CompletedNCT04609878KALOSUpdated Jun 30, 2026Results posted

Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)

A Phase 3 interventional study of BGF MDI 320/28.8/9.6 μg and BGF MDI 320/14.4/9.6 μg in Asthma, sponsored by AstraZeneca. Completed at 360 sites in 21 countries. Open to participants aged 12 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-06-30.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 2,274
Allocation: Randomized
Ages: 12 Years to 80 Years
Sex: All

Study summary

This is a variable length study to evaluate the efficacy and safety of budesonide/glycopyrronium/formoterol inhaler in adults and adolescents with severe asthma inadequately controlled with standard of care

Read the detailed description

This is a randomized, double-blind, double dummy, parallel group, multicenter 24 to 52 week variable length study to assess the efficacy and safety of budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler (MDI) relative to budesonide and formoterol fumarate MDI and Symbicort® pressurized MDI in adult and adolescent participants with inadequately controlled asthma. Approximately 2200 participants will be randomized globally.

Conditions studied

Asthma

Browse trials for

Asthma 3,921

In context

Asthma

3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.

This study's enrollment of 2,274 is above the median of 83 across 2,752 interventional studies indexed under Asthma.

Browse Asthma studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 357 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 12 Years to 80 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

12 to 80 years of age, male and female, BMI \<40 kg/m2; females must be not of childbearing potential or using a form of highly effective birth control.
Documented history of physician-diagnosed asthma > and/or = 1 year prior to V1.
Regularly using a stable daily ICS/LABA regimen (including a stable ICS dose) with medium-to-high ICS doses for at least 4 weeks prior to V1.
ACQ-7 total score ≥1.5 at Visits 1, 3, and 5 (pre-randomization).
FEV1 % (assessed as an average of the 60 and 30 minute pre-dose assessments) predicted normal at V1, 2, 3, 4, and 5 (pre-randomization)
- Participants ≥ 18 years of age: \< 80%
- Participants 12 to \<18 years of age: \< 90%
FEV1 post-albuterol at V2 or V3 (if repeat needed).
- Participants > and/or = 18 years of age: Increase > and/or = 12% and > and/or = 200 mL.
- Participants 12 to \<18 years of age: Increase =12% either in the 12 months prior to Visit 1 or at Visit 2, or at Visit 3.
- Note: Even if there is documented history of reversibility, all participants must be assessed for reversibility at Visit 2 (and Visit 3, if reversibility is not demonstrated at Visit 2) to provide reversibility baseline data for characterization.
Willing and, in the opinion of the Investigator, able to adjust current asthma therapy, as required by the protocol.
Demonstrate acceptable MDI/pMDI administration technique.
Received no asthma medication other than run-in BFF MDI BID and albuterol as needed during screening (except for allowed medications as defined in Table 9 and systemic corticosteroid or ICS for the treatment of an asthma exacerbation).
eDiary 14-day compliance ≥70% during screening (defined as completing the daily eDiary for any 10 mornings and any 10 evenings and answering "Yes" to taking 2 puffs of run-in BFF MDI for any 10 mornings and 10 evenings in the last 14 days prior to randomization).
No respiratory infection in the 4 weeks prior to randomization, or asthma exacerbation treated with systemic corticosteroid and/or additional ICS treatment in the 4 weeks prior to randomization.

Exclusion criteria

Exclusion Criteria:

1. Completed treatment for respiratory infection or asthma exacerbation with systemic corticosteroids within 4 weeks of V1.

2a. Participants where, in the opinion of the Investigator, treatment with biological therapy for asthma would be appropriate.

2b. Any marketed or investigational biologics within 3 months or 5 half-lives of V1, whichever is longer and must not be used during study duration.

3. Current smokers, former smokers with >10 pack-years history, or former smokers who stopped smoking \<6 months prior to V1 (including all forms of tobacco, e-cigarettes or other vaping devices, and marijuana).

4. Current evidence of Chronic Obstructive Pulmonary Disease (COPD).

5a. Oral and IV corticosteroid use (any dose) within 4 weeks of V1.

5b. Use of systemic corticosteroids for any other reason except for the acute treatment of severe asthma exacerbation is prohibited for the duration of the study.

5c. Depot corticosteroid use for any reason within 3 months of V1.

6. Use of Long-Acting Muscarinic Antagonist (LAMA), either alone or as part of an inhaled combination therapy, in the 12 weeks prior to V1.

7. Use of oral beta2-agonist within 3 months of V1.

8. Use of any immunomodulators or immunosuppressive medication within 3 months or 5 half-lives, whichever is longer, and must not be used during the study duration.

9. Narrow angle glaucoma not adequately treated and/or change in vision that may be relevant, in the opinion of the Investigator, within 3 months of Visit 1.

10. Life-threatening asthma defined as a history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s).

11. Hospitalization for asthma within 2 months of Visit 1.

12. Known history of drug or alcohol abuse within 12 months of Visit 1.

13. Regular use of a nebulizer or a home nebulizer for receiving asthma medications.

14. Using any herbal products by inhalation or nebulizer within 4 weeks of Visit 1 and does not agree to stop during the study duration.

15. Participation in another clinical study with a study intervention administered in the last 30 days or 5 half-lives, whichever is longer. Any other study intervention that is not identified in the protocol is prohibited for use during study duration.

16. Participants with a known hypersensitivity to beta2-agonists, corticosteroids, anticholinergics, or any component of the MDI or pMDI.

17. Study Investigators, sub-Investigators, coordinators, and their employees or immediate family members.

18. For women only - currently pregnant (confirmed with positive highly sensitive pregnancy test), breast-feeding, or planned pregnancy during the study or not using acceptable contraception measures, as judged by the Investigator.

Please refer to the study protocol for the complete inclusion and exclusion criteria list.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 2,274 participants (actual)

Study arms

Experimental
Budesonide, glycopyrronium, and formoterol fumarate (BGF) MDI 320/28.8/9.6 μg
BGF MDI 320/28.8/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI)
Drug: BGF MDI 320/28.8/9.6 μg
Experimental
BGF MDI 320/14.4/9.6 μg
BGF MDI 320/14.4/9.6 μg Budesonide, glycopyrronium, and formoterol fumarate (PT010) Metered Dose Inhaler (MDI)
Drug: BGF MDI 320/14.4/9.6 μg
Active comparator
Budesonide and formoterol fumarate (BFF) MDI 320/9.6 μg
BFF MDI 320/9.6 μg (Experimental/Comparator) Budesonide and formoterol fumarate (PT009) Metered Dose Inhaler (MDI)
Drug: BFF MDI 320/9.6 μg
Active comparator
Symbicort®
Budesonide/ formoterol fumarate pressurized metered dose inhaler (pMDI) 320/9 μg
Drug: BFF pMDI 320/9 μg

Interventions

DrugBGF MDI 320/28.8/9.6 μg
Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler
Also known as: BGF
DrugBGF MDI 320/14.4/9.6 μg
Budesonide, glycopyrronium, and formoterol fumarate metered dose inhaler
Also known as: BGF
DrugBFF MDI 320/9.6 μg
Budesonide and formoterol fumarate metered dose inhaler
Also known as: BFF
DrugBFF pMDI 320/9 μg
Budesonide/formoterol fumarate pressurized metered dose inhaler
Also known as: Symbicort®

What researchers measure

Primary outcomes

Change From Baseline in FEV1 AUC0-3 (L) at Week 24
Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24. Treatment policy was implemented to handle all intercurrent events (ICEs) with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Time frame: Week 24
Pooled (KALOS/LOGOS): Rate of Severe Asthma Exacerbations
Rate of severe asthma exacerbations was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). An asthma exacerbation was severe if it resulted in at least 1 of the following: a course of systemic corticosteroids for 3 days to treat symptoms of asthma worsening, an ER/urgent care visit that required treatment with systemic corticosteroids, an inpatient hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event of the highest severity. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Time frame: Up to 52 weeks

Secondary outcomes

Change From Baseline in Morning Pre-dose Trough FEV1 (L) at Week 24
Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Time frame: Week 24
Onset of Action on Day 1: Absolute Change in FEV1 (L) at 5 Minutes on Day 1
Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Time frame: Day 1
Percentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at Week 24
Percentage of responders in the Asthma Control Questionnaire (ACQ)-7 (≥0.5 decrease equals response) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Time frame: Week 24
Percentage of Responders in the ACQ-5 (≥0.5 Decrease Equals Response) at Week 24
Percentage of responders in ACQ-5 (≥0.5 decrease equals response) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Time frame: Week 24
Percentage of Responders in AQLQ(s)+12 (≥0.5 Increase Equals Response) at Week 24
Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(s)+12) (≥0.5 increase equals response) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Time frame: Week 24
Percentage of Responders in SGRQ (≥4.0 Decrease Equals Response) at Week 24
Percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (≥4.0 decrease equals response) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Time frame: Week 24
Pooled (KALOS/LOGOS): Rate of Severe Asthma Exacerbations for Participants With Percent Predicted FEV1 ≤55% at Baseline
Rate of severe asthma exacerbations for participants with percent predicted FEV1 ≤55% at baseline was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). An asthma exacerbation was severe if it resulted in at least 1 of the following: a course of systemic corticosteroids for 3 days to treat symptoms of asthma worsening, an ER/urgent care visit that required treatment with systemic corticosteroids, an inpatient hospitalization , or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event of the highest severity. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Time frame: Up to 52 weeks
Pooled (KALOS/LOGOS): Rate of Severe Asthma Exacerbations for Participants With ≥1 Severe Exacerbation in the 12 Months Prior to Visit 1
Rate of severe asthma exacerbations for participants with ≥1 severe exacerbation in the 12 months prior to Visit 1 was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). An asthma exacerbation was considered severe if it resulted in at least 1 of the following: a course of systemic corticosteroids for 3 days to treat symptoms of asthma worsening, an ER/urgent care visit that required treatment with systemic corticosteroids, an inpatient hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event of the highest severity. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Time frame: Up to 52 weeks
Pooled (KALOS/LOGOS): Time to First Severe Asthma Exacerbation
Time to first severe asthma exacerbation was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). Time to first severe asthma exacerbation was the time from the first dose of study medication to the time of onset of the first severe asthma exacerbation. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Time frame: Up to 52 weeks
Pooled (KALOS/LOGOS): Rate of Moderate or Severe Asthma Exacerbations
Rate of moderate or severe asthma exacerbations was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). An asthma exacerbation was severe if it resulted in at least 1 of the following: a course of systemic corticosteroids for 3 days to treat symptoms of asthma worsening, an ER/urgent care visit that required systemic corticosteroids, an inpatient hospitalization, or death related to asthma. A moderate asthma exacerbation was a worsening of symptoms that resulted in an additional ICS for 3 days. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event of the highest severity. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Time frame: Up to 52 weeks
Pooled (KALOS/LOGOS): Time to First Moderate or Severe Asthma Exacerbation
Time to first moderate/severe asthma exacerbation was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). Time to first moderate or severe asthma exacerbation was the time from the first dose of study medication to the time of onset of the first moderate or severe asthma exacerbation. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Time frame: Up to 52 weeks
Pooled (KALOS/LOGOS): Percentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at Week 24
Pooled percentage of responders in ACQ-7 (≥0.5 decrease equals response) at Week 24 was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Time frame: Week 24
Pooled (KALOS/LOGOS): Percentage of Responders in ACQ-5 (≥0.5 Decrease Equals Response) at Week 24
Pooled percentage of responders in ACQ-5 (≥0.5 decrease equals response) at Week 24 was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Time frame: Week 24
Pooled (KALOS/LOGOS): Percentage of Responders in AQLQ(s)+12 (≥0.5 Increase Equals Response) at Week 24
Pooled percentage of responders in AQLQ(s)+12 (≥0.5 increase equals response) at Week 24 was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.
Time frame: Week 24

Results

Posted Jun 30, 2026

Limitations and caveats

The study was conducted during the SARS-CoV-2 pandemic, resulting in recruitment difficulties. As such, protocol amendments were instituted to facilitate recruitment, including removal of history of exacerbation criterion and terminating recruitment to the BGF MDI 320/14.4/9.6 μg treatment group.

Participant flow

A total of 2274 subjects were randomized at 378 study centers in 20 countries from 15 December 2020. The last subject completed their last study visit on 21 March 2025. Of the 2274 randomized subjects, all populations excluded 125 subjects due to GCP violations and 5 subjects due to not receiving study therapy.

Participant flow — Overall Study
Milestone	BGF MDI 320/14.4/9.6 μg BID	BGF MDI 320/28.8/9.6 μg BID	BFF MDI 320/9.6 μg BID	Symbicort® pMDI 320/9 μg BID
Started	342	594	606	602
Completed	316	541	560	551
Not completed	26	53	46	51
Withdrew: Withdrawal by subject	12	30	29	28
Withdrew: Physician decision	3	3	8	4
Withdrew: Lost to follow-up	2	5	2	6
Withdrew: Other/not specified	2	6	1	3
Withdrew: Adverse event	4	2	2	3
Withdrew: Lack of efficacy	1	1	1	3
Withdrew: Death	1	1	1	2
Withdrew: Withdrawal by parent/guardian	0	2	1	1
Withdrew: Failure to meet randomization criteria	1	0	1	1
Withdrew: Non-compliance with study drug	0	2	0	0
Withdrew: Development of study-specific withdrawal criteria	0	1	0	0

Outcome measures

PrimaryChange From Baseline in FEV1 AUC0-3 (L) at Week 24

Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve 0 to 3 hours (AUC0-3) at Week 24. Treatment policy was implemented to handle all intercurrent events (ICEs) with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.

Time frame:: Week 24
Reported as:: Least squares mean · Liters

Change From Baseline in FEV1 AUC0-3 (L) at Week 24
Liters	BGF MDI 320/14.4/9.6 μg BID	BGF MDI 320/28.8/9.6 μg BID	BFF MDI 320/9.6 μg BID	Symbicort® pMDI 320/9 μg BID
Change From Baseline in FEV1 AUC0-3 (L) at Week 24	0.281 ± 0.018	0.316 ± 0.014	0.249 ± 0.014	0.220 ± 0.014

Statistical analysis

BGF MDI 320/14.4/9.6 μg BID vs BFF MDI 320/9.6 μg BID · ANCOVA · p = 0.168 · Ls mean difference: 0.032 · 95% CI -0.013 to 0.077An increase in estimate for comparison favors study drug. Number of subjects analyzed is based on the Efficacy Set. Only subjects with nonmissing covariates used in the analysis model were included in the analysis.
BGF MDI 320/28.8/9.6 μg BID vs BFF MDI 320/9.6 μg BID · ANCOVA · p = <0.001 · Ls mean difference: 0.068 · 95% CI 0.029 to 0.106An increase in estimate for comparison favors study drug. Number of subjects analyzed is based on the Efficacy Set. Only subjects with nonmissing covariates used in the analysis model were included in the analysis.

PrimaryPooled (KALOS/LOGOS): Rate of Severe Asthma Exacerbations

Rate of severe asthma exacerbations was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). An asthma exacerbation was severe if it resulted in at least 1 of the following: a course of systemic corticosteroids for 3 days to treat symptoms of asthma worsening, an ER/urgent care visit that required treatment with systemic corticosteroids, an inpatient hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event of the highest severity. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.

Time frame:: Up to 52 weeks
Reported as:: Number · Exacerbations/Subject Years

Pooled (KALOS/LOGOS): Rate of Severe Asthma Exacerbations
Exacerbations/Subject Years	BGF MDI 320/14.4/9.6 μg BID	BGF MDI 320/28.8/9.6 μg BID	BFF MDI 320/9.6 μg BID	Symbicort® pMDI 320/9 μg BID
Pooled (KALOS/LOGOS): Rate of Severe Asthma Exacerbations	0.533	0.541	0.604	0.662

Statistical analysis

BGF MDI 320/14.4/9.6 μg BID vs BFF MDI 320/9.6 μg BID · Negative binomial regression · p = 0.120 · Rate ratio: 0.882 · 95% CI 0.754 to 1.033A rate ratio \<1 favors study drug. Number of subjects analyzed based on the Efficacy Set, which excluded 7 subjects in D5982C00008 who were randomized across multiple Sponsor studies. Only subjects with nonmissing covariates were included.
BGF MDI 320/28.8/9.6 μg BID vs BFF MDI 320/9.6 μg BID · Negative binomial regression · p = 0.124 · Rate ratio: 0.896 · 95% CI 0.779 to 1.031A rate ratio \<1 favors study drug. Number of subjects analyzed based on the Efficacy Set, which excluded 7 subjects in D5982C00008 who were randomized across multiple Sponsor studies. Only subjects with nonmissing covariates were included.

SecondaryChange From Baseline in Morning Pre-dose Trough FEV1 (L) at Week 24

Change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.

Time frame:: Week 24
Reported as:: Least squares mean · Liters

Change From Baseline in Morning Pre-dose Trough FEV1 (L) at Week 24
Liters	BGF MDI 320/14.4/9.6 μg BID	BGF MDI 320/28.8/9.6 μg BID	BFF MDI 320/9.6 μg BID	Symbicort® pMDI 320/9 μg BID
Change From Baseline in Morning Pre-dose Trough FEV1 (L) at Week 24	0.119 ± 0.017	0.157 ± 0.013	0.115 ± 0.013	0.073 ± 0.013

Statistical analysis

BGF MDI 320/14.4/9.6 μg BID vs BFF MDI 320/9.6 μg BID · ANCOVA · p = 0.864 · Ls mean difference: 0.004 · 95% CI -0.039 to 0.046An increase in estimate for comparison favors study drug. Number of subjects analyzed is based on the Efficacy Set. Only subjects with nonmissing covariates were included in the analysis.
BGF MDI 320/28.8/9.6 μg BID vs BFF MDI 320/9.6 μg BID · ANCOVA · p = 0.022 · Ls mean difference: 0.042 · 95% CI 0.006 to 0.078An increase in estimate for comparison favors study drug. Number of subjects analyzed is based on the Efficacy Set. Only subjects with nonmissing covariates were included in the analysis.

SecondaryOnset of Action on Day 1: Absolute Change in FEV1 (L) at 5 Minutes on Day 1

Onset of action on Day 1: Absolute change in FEV1 at 5 minutes on Day 1. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.

Time frame:: Day 1
Reported as:: Mean · Liters

Onset of Action on Day 1: Absolute Change in FEV1 (L) at 5 Minutes on Day 1
Liters	BGF MDI 320/14.4/9.6 μg BID	BGF MDI 320/28.8/9.6 μg BID	BFF MDI 320/9.6 μg BID	Symbicort® pMDI 320/9 μg BID
Onset of Action on Day 1: Absolute Change in FEV1 (L) at 5 Minutes on Day 1	0.129 ± 0.194	0.161 ± 0.194	0.143 ± 0.202	0.122 ± 0.182

Statistical analysis

BGF MDI 320/14.4/9.6 μg BID · t-test, 1 sided · p = 0.003 · Within bgf mdi group t-test estimate: 0.129 · 95% CI 0.108 to 0.150Number of subjects analyzed is based on the Efficacy Set. Only subjects with nonmissing value at the visit were included in the analysis.
BGF MDI 320/28.8/9.6 μg BID · t-test, 1 sided · p = <0.001 · Within bgf mdi group t-test estimate: 0.161 · 95% CI 0.145 to 0.177Number of subjects analyzed is based on the Efficacy Set. Only subjects with nonmissing value at the visit were included in the analysis.

SecondaryPercentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at Week 24

Percentage of responders in the Asthma Control Questionnaire (ACQ)-7 (≥0.5 decrease equals response) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.

Time frame:: Week 24
Reported as:: Count of participants · Participants

Percentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at Week 24
Participants	BGF MDI 320/14.4/9.6 μg BID	BGF MDI 320/28.8/9.6 μg BID	BFF MDI 320/9.6 μg BID	Symbicort® pMDI 320/9 μg BID
Percentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at Week 24	207	370	373	342

Statistical analysis

BGF MDI 320/14.4/9.6 μg BID vs BFF MDI 320/9.6 μg BID · Regression, Logistic · p = 0.984 · Odds ratio (or): 1.00 · 95% CI 0.75 to 1.33An odds ratio \>1 for the comparison favors study drug. Number of subjects analyzed is based on the Efficacy Set. Only subjects with nonmissing covariates were included in the analysis.
BGF MDI 320/28.8/9.6 μg BID vs BFF MDI 320/9.6 μg BID · Regression, Logistic · p = 0.705 · Odds ratio (or): 1.05 · 95% CI 0.82 to 1.34An odds ratio \>1 for the comparison favors study drug. Number of subjects analyzed is based on the Efficacy Set. Only subjects with nonmissing covariates were included in the analysis.

SecondaryPercentage of Responders in the ACQ-5 (≥0.5 Decrease Equals Response) at Week 24

Percentage of responders in ACQ-5 (≥0.5 decrease equals response) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.

Time frame:: Week 24
Reported as:: Count of participants · Participants

Percentage of Responders in the ACQ-5 (≥0.5 Decrease Equals Response) at Week 24
Participants	BGF MDI 320/14.4/9.6 μg BID	BGF MDI 320/28.8/9.6 μg BID	BFF MDI 320/9.6 μg BID	Symbicort® pMDI 320/9 μg BID
Percentage of Responders in the ACQ-5 (≥0.5 Decrease Equals Response) at Week 24	223	381	394	361

Statistical analysis

BGF MDI 320/14.4/9.6 μg BID vs BFF MDI 320/9.6 μg BID · Regression, Logistic · p = 0.572 · Odds ratio (or): 1.09 · 95% CI 0.81 to 1.46An odds ratio \>1 for the comparison favors study drug. Number of subjects analyzed is based on the Efficacy Set. Only subjects with nonmissing covariates were included in the analysis.
BGF MDI 320/28.8/9.6 μg BID vs BFF MDI 320/9.6 μg BID · Regression, Logistic · p = 0.872 · Odds ratio (or): 0.98 · 95% CI 0.76 to 1.26An odds ratio \>1 for the comparison favors study drug. Number of subjects analyzed is based on the Efficacy Set. Only subjects with nonmissing covariates were included in the analysis.

SecondaryPercentage of Responders in AQLQ(s)+12 (≥0.5 Increase Equals Response) at Week 24

Percentage of responders in the Asthma Quality of Life Questionnaire for 12 years and older (AQLQ(s)+12) (≥0.5 increase equals response) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.

Time frame:: Week 24
Reported as:: Count of participants · Participants

Percentage of Responders in AQLQ(s)+12 (≥0.5 Increase Equals Response) at Week 24
Participants	BGF MDI 320/14.4/9.6 μg BID	BGF MDI 320/28.8/9.6 μg BID	BFF MDI 320/9.6 μg BID	Symbicort® pMDI 320/9 μg BID
Percentage of Responders in AQLQ(s)+12 (≥0.5 Increase Equals Response) at Week 24	171	291	292	279

Statistical analysis

BGF MDI 320/14.4/9.6 μg BID vs BFF MDI 320/9.6 μg BID · Regression, Logistic · p = 0.780 · Odds ratio (or): 1.04 · 95% CI 0.78 to 1.39An odds ratio \>1 for the comparison favors study drug. Number of subjects analyzed is based on the Efficacy Set. Only subjects with nonmissing covariates were included in the analysis.
BGF MDI 320/28.8/9.6 μg BID vs BFF MDI 320/9.6 μg BID · Regression, Logistic · p = 0.827 · Odds ratio (or): 1.03 · 95% CI 0.80 to 1.32An odds ratio \>1 for the comparison favors study drug. Number of subjects analyzed is based on the Efficacy Set. Only subjects with nonmissing covariates were included in the analysis.

SecondaryPercentage of Responders in SGRQ (≥4.0 Decrease Equals Response) at Week 24

Percentage of responders in the St. George's Respiratory Questionnaire (SGRQ) (≥4.0 decrease equals response) at Week 24. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.

Time frame:: Week 24
Reported as:: Count of participants · Participants

Percentage of Responders in SGRQ (≥4.0 Decrease Equals Response) at Week 24
Participants	BGF MDI 320/14.4/9.6 μg BID	BGF MDI 320/28.8/9.6 μg BID	BFF MDI 320/9.6 μg BID	Symbicort® pMDI 320/9 μg BID
Percentage of Responders in SGRQ (≥4.0 Decrease Equals Response) at Week 24	181	346	310	298

Statistical analysis

BGF MDI 320/14.4/9.6 μg BID vs BFF MDI 320/9.6 μg BID · Regression, Logistic · p = 0.763 · Odds ratio (or): 1.05 · 95% CI 0.78 to 1.39An odds ratio \>1 for the comparison favors study drug. Number of subjects analyzed is based on the Efficacy Set. Only subjects with nonmissing covariates were included in the analysis.
BGF MDI 320/28.8/9.6 μg BID vs BFF MDI 320/9.6 μg BID · Regression, Logistic · p = 0.026 · Odds ratio (or): 1.33 · 95% CI 1.03 to 1.70An odds ratio \>1 for the comparison favors study drug. Number of subjects analyzed is based on the Efficacy Set. Only subjects with nonmissing covariates were included in the analysis.

SecondaryPooled (KALOS/LOGOS): Rate of Severe Asthma Exacerbations for Participants With Percent Predicted FEV1 ≤55% at Baseline

Rate of severe asthma exacerbations for participants with percent predicted FEV1 ≤55% at baseline was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). An asthma exacerbation was severe if it resulted in at least 1 of the following: a course of systemic corticosteroids for 3 days to treat symptoms of asthma worsening, an ER/urgent care visit that required treatment with systemic corticosteroids, an inpatient hospitalization , or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event of the highest severity. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.

Time frame:: Up to 52 weeks
Reported as:: Number · Exacerbations/Subject Years

Pooled (KALOS/LOGOS): Rate of Severe Asthma Exacerbations for Participants With Percent Predicted FEV1 ≤55% at Baseline
Exacerbations/Subject Years	BGF MDI 320/14.4/9.6 μg BID	BGF MDI 320/28.8/9.6 μg BID	BFF MDI 320/9.6 μg BID	Symbicort® pMDI 320/9 μg BID
Pooled (KALOS/LOGOS): Rate of Severe Asthma Exacerbations for Participants With Percent Predicted FEV1 ≤55% at Baseline	0.733	0.663	0.780	0.815

Statistical analysis

BGF MDI 320/14.4/9.6 μg BID vs BFF MDI 320/9.6 μg BID · Negative binomial regression · p = 0.620 · Rate ratio: 0.940 · 95% CI 0.736 to 1.200A rate ratio \<1 favors study drug. Number of subjects analyzed based on the Efficacy Set, which excluded 7 subjects in D5982C00008 who were randomized across multiple Sponsor studies. Only subjects with nonmissing covariates were included.
BGF MDI 320/28.8/9.6 μg BID vs BFF MDI 320/9.6 μg BID · Negative binomial regression · p = 0.146 · Rate ratio: 0.850 · 95% CI 0.682 to 1.058A rate ratio \<1 favors study drug. Number of subjects analyzed based on the Efficacy Set, which excluded 7 subjects in D5982C00008 who were randomized across multiple Sponsor studies. Only subjects with nonmissing covariates were included.

SecondaryPooled (KALOS/LOGOS): Rate of Severe Asthma Exacerbations for Participants With ≥1 Severe Exacerbation in the 12 Months Prior to Visit 1

Rate of severe asthma exacerbations for participants with ≥1 severe exacerbation in the 12 months prior to Visit 1 was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). An asthma exacerbation was considered severe if it resulted in at least 1 of the following: a course of systemic corticosteroids for 3 days to treat symptoms of asthma worsening, an ER/urgent care visit that required treatment with systemic corticosteroids, an inpatient hospitalization, or death related to asthma. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event of the highest severity. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.

Time frame:: Up to 52 weeks
Reported as:: Number · Exacerbations/Subject Years

Pooled (KALOS/LOGOS): Rate of Severe Asthma Exacerbations for Participants With ≥1 Severe Exacerbation in the 12 Months Prior to Visit 1
Exacerbations/Subject Years	BGF MDI 320/14.4/9.6 μg BID	BGF MDI 320/28.8/9.6 μg BID	BFF MDI 320/9.6 μg BID	Symbicort® pMDI 320/9 μg BID
Pooled (KALOS/LOGOS): Rate of Severe Asthma Exacerbations for Participants With ≥1 Severe Exacerbation in the 12 Months Prior to Visit 1	0.707	0.653	0.710	0.805

Statistical analysis

BGF MDI 320/14.4/9.6 μg BID vs BFF MDI 320/9.6 μg BID · Negative binomial regression · p = 0.970 · Rate ratio: 0.996 · 95% CI 0.826 to 1.202A rate ratio \<1 favors study drug. Number of subjects analyzed based on the Efficacy Set, which excluded 7 subjects in D5982C00008 who were randomized across multiple Sponsor studies. Only subjects with nonmissing covariates were included.
BGF MDI 320/28.8/9.6 μg BID vs BFF MDI 320/9.6 μg BID · Negative binomial regression · p = 0.354 · Rate ratio: 0.921 · 95% CI 0.773 to 1.097A rate ratio \<1 favors study drug. Number of subjects analyzed based on the Efficacy Set, which excluded 7 subjects in D5982C00008 who were randomized across multiple Sponsor studies. Only subjects with nonmissing covariates were included.

SecondaryPooled (KALOS/LOGOS): Time to First Severe Asthma Exacerbation

Time to first severe asthma exacerbation was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). Time to first severe asthma exacerbation was the time from the first dose of study medication to the time of onset of the first severe asthma exacerbation. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.

Time frame:: Up to 52 weeks
Reported as:: Number · Percentage of participants

Pooled (KALOS/LOGOS): Time to First Severe Asthma Exacerbation
Percentage of participants	BGF MDI 320/14.4/9.6 μg BID	BGF MDI 320/28.8/9.6 μg BID	BFF MDI 320/9.6 μg BID	Symbicort® pMDI 320/9 μg BID
Kaplan-Meier estimate at 24 weeks (%)	18.9	18.6	20.8	22.3
Kaplan-Meier estimate at 52 weeks (%)	36.0	35.5	39.2	41.5

Statistical analysis

BGF MDI 320/14.4/9.6 μg BID vs BFF MDI 320/9.6 μg BID · Regression, Cox · p = 0.145 (Endpoint not included in the Type I error control procedure.) · Hazard ratio (hr): 0.892 · 95% CI 0.765 to 1.040A hazard ratio \<1 favors study drug. Number of subjects analyzed based on the Efficacy Set, which excluded 7 subjects in D5982C00008 who were randomized across multiple Sponsor studies. Only subjects with nonmissing covariates were included.
BGF MDI 320/28.8/9.6 μg BID vs BFF MDI 320/9.6 μg BID · Regression, Cox · p = 0.061 (Endpoint not included in the Type I error control procedure.) · Hazard ratio (hr): 0.879 · 95% CI 0.767 to 1.006A hazard ratio \<1 favors study drug. Number of subjects analyzed based on the Efficacy Set, which excluded 7 subjects in D5982C00008 who were randomized across multiple Sponsor studies. Only subjects with nonmissing covariates were included.

SecondaryPooled (KALOS/LOGOS): Rate of Moderate or Severe Asthma Exacerbations

Rate of moderate or severe asthma exacerbations was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). An asthma exacerbation was severe if it resulted in at least 1 of the following: a course of systemic corticosteroids for 3 days to treat symptoms of asthma worsening, an ER/urgent care visit that required systemic corticosteroids, an inpatient hospitalization, or death related to asthma. A moderate asthma exacerbation was a worsening of symptoms that resulted in an additional ICS for 3 days. Consecutive exacerbations with start/stop days ≤7 days apart were considered the same event of the highest severity. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.

Time frame:: Up to 52 weeks
Reported as:: Number · Exacerbations/Subject Years

Pooled (KALOS/LOGOS): Rate of Moderate or Severe Asthma Exacerbations
Exacerbations/Subject Years	BGF MDI 320/14.4/9.6 μg BID	BGF MDI 320/28.8/9.6 μg BID	BFF MDI 320/9.6 μg BID	Symbicort® pMDI 320/9 μg BID
Pooled (KALOS/LOGOS): Rate of Moderate or Severe Asthma Exacerbations	0.545	0.555	0.626	0.680

Statistical analysis

BGF MDI 320/14.4/9.6 μg BID vs BFF MDI 320/9.6 μg BID · Negative binomial regression · p = 0.079 (Endpoint not included in the Type I error control procedure.) · Rate ratio: 0.869 · 95% CI 0.744 to 1.016A rate ratio \<1 favors study drug. Number of subjects analyzed based on the Efficacy Set, which excluded 7 subjects in D5982C00008 who were randomized across multiple Sponsor studies. Only subjects with nonmissing covariates were included.
BGF MDI 320/28.8/9.6 μg BID vs BFF MDI 320/9.6 μg BID · Negative binomial regression · p = 0.088 (Endpoint not included in the Type I error control procedure.) · Rate ratio: 0.886 · 95% CI 0.772 to 1.018A rate ratio \<1 favors study drug. Number of subjects analyzed based on the Efficacy Set, which excluded 7 subjects in D5982C00008 who were randomized across multiple Sponsor studies. Only subjects with nonmissing covariates were included.

SecondaryPooled (KALOS/LOGOS): Time to First Moderate or Severe Asthma Exacerbation

Time to first moderate/severe asthma exacerbation was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). Time to first moderate or severe asthma exacerbation was the time from the first dose of study medication to the time of onset of the first moderate or severe asthma exacerbation. Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.

Time frame:: Up to 52 weeks
Reported as:: Number · Percentage of participants

Pooled (KALOS/LOGOS): Time to First Moderate or Severe Asthma Exacerbation
Percentage of participants	BGF MDI 320/14.4/9.6 μg BID	BGF MDI 320/28.8/9.6 μg BID	BFF MDI 320/9.6 μg BID	Symbicort® pMDI 320/9 μg BID
Kaplan-Meier estimate at 24 weeks (%)	19.1	19.1	21.4	22.9
Kaplan-Meier estimate at 52 weeks (%)	36.3	36.2	40.0	42.3

Statistical analysis

BGF MDI 320/14.4/9.6 μg BID vs BFF MDI 320/9.6 μg BID · Regression, Cox · p = 0.097 (Endpoint not included in the Type I error control procedure.) · Hazard ratio (hr): 0.878 · 95% CI 0.754 to 1.024A hazard ratio \<1 favors study drug. Number of subjects analyzed based on the Efficacy Set, which excluded 7 subjects in D5982C00008 who were randomized across multiple Sponsor studies. Only subjects with nonmissing covariates were included.
BGF MDI 320/28.8/9.6 μg BID vs BFF MDI 320/9.6 μg BID · Regression, Cox · p = 0.055 (Endpoint not included in the Type I error control procedure.) · Hazard ratio (hr): 0.877 · 95% CI 0.767 to 1.003A hazard ratio \<1 favors study drug. Number of subjects analyzed based on the Efficacy Set, which excluded 7 subjects in D5982C00008 who were randomized across multiple Sponsor studies. Only subjects with nonmissing covariates were included.

SecondaryPooled (KALOS/LOGOS): Percentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at Week 24

Pooled percentage of responders in ACQ-7 (≥0.5 decrease equals response) at Week 24 was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.

Time frame:: Week 24
Reported as:: Count of participants · Participants

Pooled (KALOS/LOGOS): Percentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at Week 24
Participants	BGF MDI 320/14.4/9.6 μg BID	BGF MDI 320/28.8/9.6 μg BID	BFF MDI 320/9.6 μg BID	Symbicort® pMDI 320/9 μg BID
Pooled (KALOS/LOGOS): Percentage of Responders in ACQ-7 (≥0.5 Decrease Equals Response) at Week 24	458	741	733	693

Statistical analysis

BGF MDI 320/14.4/9.6 μg BID vs BFF MDI 320/9.6 μg BID · Regression, Logistic · p = 0.215 (Endpoint not included in the Type I error control procedure.) · Odds ratio (or): 1.14 · 95% CI 0.93 to 1.39An odds ratio \>1 favors study drug. Number of subjects analyzed based on the Efficacy Set, which excluded 7 subjects in D5982C00008 who were randomized across multiple Sponsor studies. Only subjects with nonmissing covariates were included.
BGF MDI 320/28.8/9.6 μg BID vs BFF MDI 320/9.6 μg BID · Regression, Logistic · p = 0.123 (Endpoint not included in the Type I error control procedure.) · Odds ratio (or): 1.15 · 95% CI 0.96 to 1.37An odds ratio \>1 favors study drug. Number of subjects analyzed based on the Efficacy Set, which excluded 7 subjects in D5982C00008 who were randomized across multiple Sponsor studies. Only subjects with nonmissing covariates were included.

SecondaryPooled (KALOS/LOGOS): Percentage of Responders in ACQ-5 (≥0.5 Decrease Equals Response) at Week 24

Pooled percentage of responders in ACQ-5 (≥0.5 decrease equals response) at Week 24 was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.

Time frame:: Week 24
Reported as:: Count of participants · Participants

Pooled (KALOS/LOGOS): Percentage of Responders in ACQ-5 (≥0.5 Decrease Equals Response) at Week 24
Participants	BGF MDI 320/14.4/9.6 μg BID	BGF MDI 320/28.8/9.6 μg BID	BFF MDI 320/9.6 μg BID	Symbicort® pMDI 320/9 μg BID
Pooled (KALOS/LOGOS): Percentage of Responders in ACQ-5 (≥0.5 Decrease Equals Response) at Week 24	486	769	781	741

Statistical analysis

BGF MDI 320/14.4/9.6 μg BID vs BFF MDI 320/9.6 μg BID · Regression, Logistic · p = 0.170 (Endpoint not included in the Type I error control procedure.) · Odds ratio (or): 1.16 · 95% CI 0.94 to 1.42An odds ratio \>1 favors study drug. Number of subjects analyzed based on the Efficacy Set, which excluded 7 subjects in D5982C00008 who were randomized across multiple Sponsor studies. Only subjects with nonmissing covariates were included.
BGF MDI 320/28.8/9.6 μg BID vs BFF MDI 320/9.6 μg BID · Regression, Logistic · p = 0.444 (Endpoint not included in the Type I error control procedure.) · Odds ratio (or): 1.07 · 95% CI 0.90 to 1.28An odds ratio \>1 favors study drug. Number of subjects analyzed based on the Efficacy Set, which excluded 7 subjects in D5982C00008 who were randomized across multiple Sponsor studies. Only subjects with nonmissing covariates were included.

SecondaryPooled (KALOS/LOGOS): Percentage of Responders in AQLQ(s)+12 (≥0.5 Increase Equals Response) at Week 24

Pooled percentage of responders in AQLQ(s)+12 (≥0.5 increase equals response) at Week 24 was assessed in a pre-specified pooled analysis across replicate studies D5982C00007 and D5982C00008 (NCT04609904). Treatment policy was implemented to handle all ICEs with the exception of initiation of new asthma therapy or use of prohibited medications thought to impact efficacy in conjunction with premature discontinuation of study intervention, for which the composite strategy was implemented.

Time frame:: Week 24
Reported as:: Count of participants · Participants

Pooled (KALOS/LOGOS): Percentage of Responders in AQLQ(s)+12 (≥0.5 Increase Equals Response) at Week 24
Participants	BGF MDI 320/14.4/9.6 μg BID	BGF MDI 320/28.8/9.6 μg BID	BFF MDI 320/9.6 μg BID	Symbicort® pMDI 320/9 μg BID
Pooled (KALOS/LOGOS): Percentage of Responders in AQLQ(s)+12 (≥0.5 Increase Equals Response) at Week 24	376	588	593	568

Statistical analysis

BGF MDI 320/14.4/9.6 μg BID vs BFF MDI 320/9.6 μg BID · Regression, Logistic · p = 0.539 (Endpoint not included in the Type I error control procedure.) · Odds ratio (or): 1.07 · 95% CI 0.87 to 1.30An odds ratio \>1 favors study drug. Number of subjects analyzed based on the Efficacy Set, which excluded 7 subjects in D5982C00008 who were randomized across multiple Sponsor studies. Only subjects with nonmissing covariates were included.
BGF MDI 320/28.8/9.6 μg BID vs BFF MDI 320/9.6 μg BID · Regression, Logistic · p = 0.398 (Endpoint not included in the Type I error control procedure.) · Odds ratio (or): 1.08 · 95% CI 0.90 to 1.29An odds ratio \>1 favors study drug. Number of subjects analyzed based on the Efficacy Set, which excluded 7 subjects in D5982C00008 who were randomized across multiple Sponsor studies. Only subjects with nonmissing covariates were included.

Adverse events

Collected over Up to 52 Weeks with a 2-week safety follow-up period; adverse events were collected from first intake of study intervention after Visit 1, during screening, and throughout the Treatment Period and including the follow-up period. "All-Cause Mortality" events are presented for the on-study period and SAEs are presented for the on-treatment period.. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
BGF MD I320/14.4/9.6 μg BID	1/342 (0.3%)	18/342 (5.3%)	81/342 (23.7%)
BGF MDI 320/28.8/9.6 μg BID	1/594 (0.2%)	32/594 (5.4%)	109/594 (18.4%)
BFF MDI 320/9.6 μg BID	1/606 (0.2%)	34/606 (5.6%)	123/606 (20.3%)
Symbicort® pMDI 320/9 μg BID	2/602 (0.3%)	32/602 (5.3%)	119/602 (19.8%)

Most frequent serious events

Showing 10 of 78

Most frequent serious events
Event	BGF MD I320/14.4/9.6 μg BID	BGF MDI 320/28.8/9.6 μg BID	BFF MDI 320/9.6 μg BID	Symbicort® pMDI 320/9 μg BID
AsthmaRespiratory, thoracic and mediastinal disorders	3/342	11/594	11/606	8/602
PneumoniaInfections and infestations	0/342	4/594	4/606	1/602
Iron deficiency anaemiaBlood and lymphatic system disorders	2/342	0/594	0/606	0/602
Coronary artery diseaseCardiac disorders	0/342	0/594	3/606	0/602
Atrial fibrillationCardiac disorders	0/342	2/594	0/606	0/602
Pneumonia bacterialInfections and infestations	1/342	0/594	2/606	1/602
PericarditisCardiac disorders	0/342	0/594	2/606	0/602
Lung abscessInfections and infestations	1/342	0/594	0/606	1/602
Pneumonia viralInfections and infestations	1/342	0/594	0/606	0/602
Pyelonephritis acuteInfections and infestations	1/342	0/594	0/606	0/602

Most frequent other events

Most frequent other events
Event	BGF MD I320/14.4/9.6 μg BID	BGF MDI 320/28.8/9.6 μg BID	BFF MDI 320/9.6 μg BID	Symbicort® pMDI 320/9 μg BID
NasopharyngitisInfections and infestations	37/342	49/594	51/606	52/602
Upper respiratory tract infectionInfections and infestations	21/342	43/594	52/606	39/602
COVID-19Infections and infestations	28/342	30/594	30/606	33/602

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	BGF MDI 320/14.4/9.6 μg BID	BGF MDI 320/28.8/9.6 μg BID	BFF MDI 320/9.6 μg BID	Symbicort® pMDI 320/9 μg BID	Total
Age group (years) — <=18 years	10	16	22	22	70
Age group (years) — Between 18 and 65 years	247	437	450	432	1566
Age group (years) — >=65 years	85	141	134	148	508

Sex: Female, Male
Sex: Female, Male(Participants)	BGF MDI 320/14.4/9.6 μg BID	BGF MDI 320/28.8/9.6 μg BID	BFF MDI 320/9.6 μg BID	Symbicort® pMDI 320/9 μg BID	Total
Sex — Female	228	384	376	403	1391
Sex — Male	114	210	230	199	753

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	BGF MDI 320/14.4/9.6 μg BID	BGF MDI 320/28.8/9.6 μg BID	BFF MDI 320/9.6 μg BID	Symbicort® pMDI 320/9 μg BID	Total
Ethnicity — Hispanic or Latino	112	184	178	190	664
Ethnicity — Not Hispanic or Latino	230	410	428	412	1480
Ethnicity — Unknown or Not Reported	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	BGF MDI 320/14.4/9.6 μg BID	BGF MDI 320/28.8/9.6 μg BID	BFF MDI 320/9.6 μg BID	Symbicort® pMDI 320/9 μg BID	Total
Race — American Indian or Alaska Native	4	2	5	4	15
Race — Asian	72	147	142	157	518
Race — Native Hawaiian or Other Pacific Islander	0	0	0	0	0
Race — Black or African American	9	12	15	9	45
Race — White	216	384	397	378	1375
Race — More than one race	41	49	47	54	191
Race — Unknown or Not Reported	0	0	0	0	0

Region of Enrollment
Region of Enrollment(Participants)	BGF MDI 320/14.4/9.6 μg BID	BGF MDI 320/28.8/9.6 μg BID	BFF MDI 320/9.6 μg BID	Symbicort® pMDI 320/9 μg BID	Total
Argentina	59	102	100	100	361
Belgium	1	0	0	1	2
Bulgaria	51	81	85	81	298
Canada	10	14	15	14	53
Chile	11	25	25	23	84
Hungary	25	36	33	36	130
India	25	37	36	42	140
Italy	3	5	7	6	21
Japan	5	18	13	16	52
New Zealand	1	0	1	0	2
Peru	40	42	41	41	164
Philippines	10	34	32	35	111
Poland	22	60	59	58	199
Korea, Republic Of	7	9	10	14	40
Romania	11	19	22	19	71
Spain	4	8	11	10	33
Taiwan, China	5	12	10	7	34
Thailand	6	12	18	14	50
United States	35	57	69	63	224
Viet Nam	11	23	19	22	75

Baseline Reversibility (%)
Baseline Reversibility (%)(Percentage)	BGF MDI 320/14.4/9.6 μg BID	BGF MDI 320/28.8/9.6 μg BID	BFF MDI 320/9.6 μg BID	Symbicort® pMDI 320/9 μg BID	Total
Mean	24.5 ± 19.8	23.6 ± 19.9	22.5 ± 17.4	22.0 ± 16.9	23.0 ± 18.4

Baseline Pre-bronchodilator Percent Predicted FEV1 (%)
Baseline Pre-bronchodilator Percent Predicted FEV1 (%)(Percentage)	BGF MDI 320/14.4/9.6 μg BID	BGF MDI 320/28.8/9.6 μg BID	BFF MDI 320/9.6 μg BID	Symbicort® pMDI 320/9 μg BID	Total
Mean	58.6 ± 12.6	58.3 ± 12.2	59.3 ± 12.1	58.5 ± 12.5	58.7 ± 12.3

Baseline Severe Asthma Exacerbation History Within the Prior Year
Baseline Severe Asthma Exacerbation History Within the Prior Year(Participants)	BGF MDI 320/14.4/9.6 μg BID	BGF MDI 320/28.8/9.6 μg BID	BFF MDI 320/9.6 μg BID	Symbicort® pMDI 320/9 μg BID	Total
0 exacerbations	74	204	216	204	698
1 exacerbation	186	275	261	272	994
≥2 exacerbations	82	115	129	126	452

1 further baseline measures are reported on the registry.

Study locations

360 sites

Research Site
Saraland, Alabama 36571, United States
Research Site
Phoenix, Arizona 85018, United States
Research Site
Phoenix, Arizona 85027, United States
Research Site
Sun City West, Arizona 85375, United States
Research Site
Tucson, Arizona 85715, United States
Research Site
Tucson, Arizona 85745, United States
Research Site
Little Rock, Arkansas 72209, United States
Research Site
Covina, California 91723, United States
Research Site
Encinitas, California 92024, United States
Research Site
Fresno, California 93701, United States
Research Site
Laguna Hills, California 92653, United States
Research Site
Long Beach, California 90806, United States
Research Site
Los Angeles, California 90017, United States
Research Site
Los Angeles, California 90027, United States
Research Site
Mission Hills, California 91345, United States
Research Site
Newport Beach, California 92663, United States
Research Site
Northridge, California 91324, United States
Research Site
San Diego, California 92119, United States
Research Site
Stockton, California 95207, United States
Research Site
Thousand Oaks, California 91360, United States
Research Site
Upland, California 91786, United States
Research Site
Westminster, California 92683, United States
Research Site
Colorado Springs, Colorado 80923, United States
Research Site
Lakewood, Colorado 80228, United States
Research Site
Brandon, Florida 33511, United States
Research Site
Miami, Florida 33175, United States
Research Site
Tampa, Florida 33607, United States
Research Site
Adairsville, Georgia 30103, United States
Research Site
Atlanta, Georgia 30344, United States
Research Site
Columbus, Georgia 31904, United States
Research Site
Lawrenceville, Georgia 30046, United States
Research Site
Rincon, Georgia 31326, United States
Research Site
Savannah, Georgia 31406, United States
Research Site
Tyrone, Georgia 30290, United States
Research Site
Chicago, Illinois 60657, United States
Research Site
River Forest, Illinois 60305, United States
Research Site
Brownsburg, Indiana 46112, United States
Research Site
Indianapolis, Indiana 46202, United States
Research Site
Louisville, Kentucky 40217, United States
Research Site
Crowley, Louisiana 70526, United States
Research Site
Lafayette, Louisiana 70508, United States
Research Site
Lake Charles, Louisiana 70601, United States
Research Site
Bangor, Maine 04401, United States
Research Site
Potomac, Maryland 20854, United States
Research Site
Waldorf, Maryland 20601, United States
Research Site
Boston, Massachusetts 02115, United States
Research Site
Hannibal, Missouri 63401, United States
Research Site
St Louis, Missouri 63141, United States
Research Site
Missoula, Montana 59808, United States
Research Site
Bellevue, Nebraska 68123, United States
Research Site
Lincoln, Nebraska 68510, United States
Research Site
Las Vegas, Nevada 89106, United States
Research Site
Toms River, New Jersey 08755, United States
Research Site
Albuquerque, New Mexico 87108, United States
Research Site
New Hyde Park, New York 11042, United States
Research Site
New Windsor, New York 12553, United States
Research Site
New York, New York 10016, United States
Research Site
The Bronx, New York 10455, United States
Research Site
Charlotte, North Carolina 28277, United States
Research Site
Denver, North Carolina 28037, United States
Research Site
Gastonia, North Carolina 28054, United States
Research Site
Raleigh, North Carolina 27607, United States
Research Site
Fargo, North Dakota 58104, United States
Research Site
Cincinnati, Ohio 45229, United States
Research Site
Cincinnati, Ohio 45231, United States
Research Site
Maumee, Ohio 43537, United States
Research Site
Toledo, Ohio 43617, United States
Research Site
Edmond, Oklahoma 73034, United States
Research Site
Oklahoma City, Oklahoma 73120, United States
Research Site
Tulsa, Oklahoma 74133, United States
Research Site
Grants Pass, Oregon 97527, United States
Research Site
DuBois, Pennsylvania 15801, United States
Research Site
Pittsburgh, Pennsylvania 15236, United States
Research Site
Pittsburgh, Pennsylvania 15241, United States
Research Site
Scottdale, Pennsylvania 15683, United States
Research Site
Smithfield, Pennsylvania 15478, United States
Research Site
East Providence, Rhode Island 02914, United States
Research Site
Anderson, South Carolina 29621, United States
Research Site
Greenville, South Carolina 29607, United States
Research Site
North Charleston, South Carolina 29406, United States
Research Site
Franklin, Tennessee 37067, United States
Research Site
Amarillo, Texas 79106, United States
Research Site
Austin, Texas 78759, United States
Research Site
Boerne, Texas 78006, United States
Research Site
Cypress, Texas 77429, United States
Research Site
Dallas, Texas 75231, United States
Research Site
El Paso, Texas 79912, United States
Research Site
Harlingen, Texas 78550, United States
Research Site
Houston, Texas 77021, United States
Research Site
Houston, Texas 77030, United States
Research Site
Kerrville, Texas 78028, United States
Research Site
Lampasas, Texas 76550, United States
Research Site
Nederland, Texas 77627, United States
Research Site
Pearland, Texas 77584, United States
Research Site
Red Oak, Texas 75154, United States
Research Site
San Antonio, Texas 78215, United States
Research Site
San Antonio, Texas 78229, United States
Research Site
San Antonio, Texas 78258, United States
Research Site
Spring, Texas 77386, United States
Research Site
Tomball, Texas 77375, United States

Showing the first 100 of 360 sites across 21 countries.

References and documents

Publications

Papi A, Wise RA, Jackson DJ, Lugogo N, Chen R, Trasieva T, Obasi C, Movitz C, Helman J, Salter P, Springer K, Bondoc M, Shah M, Knappenberger K, Bowen K, Pandya H, Megally A, Patel M; KALOS and LOGOS study investigators. Budesonide-glycopyrronium-formoterol fumarate dihydrate in uncontrolled asthma (KALOS and LOGOS): twin multicentre, double-blind, double-dummy, parallel-group, randomised, phase 3 trials. Lancet Respir Med. 2026 Apr;14(4):350-362. doi: 10.1016/S2213-2600(25)00457-6. Epub 2026 Feb 12. PubMed 41692019 ↗
Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2. PubMed 36472162 ↗

Study documents

Study protocol · Nov 19, 2024
Statistical analysis plan · Mar 24, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure

Supporting information: Study protocol, Sap

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jun 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04609878
Lead sponsor: AstraZeneca
Responsible party: Sponsor
First posted: Oct 30, 2020
Start date: Dec 15, 2020
Primary completion: Mar 21, 2025
Completion: Mar 21, 2025
Results posted: Jun 30, 2026
Last update: Jun 30, 2026

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Asthma→

Other studies from this sponsor

AstraZeneca

Start the discussion

Study to Assess PT010 in Adult and Adolescent Participants With Inadequately Controlled Asthma (KALOS)

Study summary

Conditions studied

Browse trials for

In context

Asthma

Lead sponsor

Who can participate

✓Inclusion criteria

✕Exclusion criteria

Study design

Study arms

Interventions

What researchers measure

Primary outcomes

Secondary outcomes

Results

Participant flow

Outcome measures

Adverse events

Baseline characteristics

Study locations

References and documents

Publications

Related links

Study documents

Individual participant data

Updates

Registry details

Key details

Oversight

Not currently enrolling

Follow this study

Discussion

Other studies in this condition

Other studies from this sponsor

Inclusion criteria

Exclusion criteria