A Phase 3 interventional study of BGF MDI 320/14.4/9.6 μg and GFF MDI (PT003) 14.4/9.6 μg in COPD, sponsored by Pearl Therapeutics, Inc.. Completed at 190 sites in 4 countries. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-12-24.
Sponsored by Pearl Therapeutics, Inc. (part of AstraZeneca) · Phase 3, Interventional, and Treatment
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Among 43 studies testing budesonide in Pulmonary Disease, Chronic Obstructive — 3 open to participants now, 3 under way, 1 of them phase 3. Budesonide · Pulmonary Disease, Chronic Obstructive.
Among the 43 studies testing budesonide in Pulmonary Disease, Chronic Obstructive, this one is the 5th largest by enrollment, is one of 7 that started in 2015, is one of 15 in phase 3, and was the 23rd registered.
5,522 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 857 are open to participants now.
Browse Pulmonary Disease, Chronic Obstructive studies →3 of the 43 studies testing budesonide in Pulmonary Disease, Chronic Obstructive are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in Germany, United Kingdom
Ages 40–80
Maria Joyera Rodríguez · Sites in Germany, Netherlands, Spain and 1 more country
Ages 40+
AstraZeneca · Sites in United States, Argentina, Australia and 34 more countries
Ages 40–80
By country, each count listing its studies:
Budesonide: first FDA approval 1994 (RHINOCORT), first EMA approval 2014. What it is approved for, and how studies give it, is on its page →
Of the 557 Pulmonary Disease, Chronic Obstructive studies recruiting now, 306 (55%) set no upper age limit and 82 (15%) stop at 75 or younger; 29 take children under 18; 88 take healthy volunteers.
This study: 40 Years to 80 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
43 studies; the count open now beside each. This study's row is marked.
First in 1999; this study’s year is marked. 7 started in 2015.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,902 is above the median of 62 across 3,840 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Median enrollment 99 across the 43 interventional studies. Of the 37 that completed or were terminated, 16 (43%) have results posted.
This tab as a report to print or save as PDF → With an account.
25 of 43 have an industry lead sponsor. The 10 most frequent:
This study is registered under Pearl Therapeutics, Inc., one of the names counted as AstraZeneca. Under that name alone:
Pearl Therapeutics, Inc. is the lead sponsor of 42 studies on the registry; none are open to participants now.
Of its 16 completed or terminated interventional studies of FDA-regulated products, 15 (94%) have results posted.
284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca: 14 open now, 15 under way, 4 of them phase 3. Of 264 finished, 127 (48%) have results posted.
Among the 284 studies in Pulmonary Disease, Chronic Obstructive by AstraZeneca, this one is the 11th largest by enrollment of the 194 interventional ones that give a count, is one of 19 that started in 2015, is one of 76 in phase 3, and was the 172nd registered.
AstraZeneca’s Pulmonary Disease, Chronic Obstructive studies by the year they started, since 1999.
1 of the studies testing budesonide in Pulmonary Disease, Chronic Obstructive that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07073950AstraZenecaA Study to Investigate the Effect of Budesonide/Glycopyrronium/Formoterol Fumarate Metered Dose Inhaler (BGF MDI) Compared With Placebo MDI on Heart and Lung Function in Participants With Chronic Obstructive Pulmonary Disease (COPD) and Hyperinflation | 2027-05-31 |
Add it to your calendar (.ics) → With an account.
Among the 43 studies testing budesonide in Pulmonary Disease, Chronic Obstructive, from their registry updates:
Nothing recorded among them since 2026-09-25.
Among AstraZeneca’s 284 in Pulmonary Disease, Chronic Obstructive:
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Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease.
A Randomized, Double-Blind, Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared With Symbicort® Turbuhaler® as an Active Control in Subjects with Moderate to Very Severe Chronic Obstructive Pulmonary Disease
This study includes the following 3 sub-studies: 12-hour Pulmonary Function Test (PFT), Pharmacokinetic (PK) Profile, and Hypothalamic-pituitary-adrenal Axis.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Please refer to the study protocol for the complete inclusion criteria list.
Exclusion Criteria
Please refer to the study protocol for the complete inclusion criteria list.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BGF MDI 320/14.4/9.6 μg,Budesonide, Glycopyrronium, Formoterol Fumarate Inhalation Aerosol
Drug: BGF MDI 320/14.4/9.6 μg
GFF MDI 14.4/9.6 μg ex-actuator Glycopyrronium, Formoterol Fumarate Inhalation Aerosol
Drug: GFF MDI (PT003) 14.4/9.6 μg
BFF MDI 320/9.6 μg, Budesonide, Formoterol Fumarate Inhalation Aerosol
Drug: BFF MDI (PT009) 320/9.6 μg
Symbicort® Turbuhaler® (TBH) Inhalation Powder 200/6 μg
Drug: Symbicort® Turbuhaler® (TBH) Inhalation Powder
Drug pages: Budesonide · Glycopyrrolate · Formoterol
Budesonide, Glycopyrronium, and Formoterol Fumarate Inhalation Aerosol (PT010, BGF metered dose inhaler \[MDI\])
Also known as: BGF
Glycopyrronium and Formoterol Fumarate Inhalation Aerosol (PT003, GFF MDI)
Also known as: GFF
Drug pages: Budesonide · Formoterol
Budesonide and Formoterol Fumarate Inhalation Aerosol (PT009, BFF MDI)
Also known as: BFF
FEV1 AUC0-4
FEV1 AUC0-4 (L) for The Efficacy Estimand (Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 4 hours (AUC0-4) AUC was normalized for length of follow up (e.g. typically 4 hours)).
Time frame: at Week 24
Change From Baseline in Morning Pre-dose Trough FEV1
Morning Pre-Dose Trough FEV1 (L) for The Efficacy Estimand
Time frame: at Week 24
Change From Baseline in Morning Pre-dose Trough FEV1
Morning Pre-Dose Trough FEV1 (L) for The Efficacy Estimand
Time frame: over 24 Weeks
Peak Change From Baseline in FEV1 Within 4 Hours Post-dosing
Peak Change from Baseline in FEV1 (L) Within 4 Hours Post-Dose for The Efficacy Estimand
Time frame: at Week 24
Rate of Moderate or Severe COPD Exacerbations
Rate of Moderate or Severe COPD Exacerbations for the Efficacy Estimand
Time frame: over 24 weeks
Percentage of Subjects Achieving a Minimal Clinically Important Difference (MCID) of 4 Units or More in SGRQ Total Score (SGRQ Responders)
Change from BGF
Time frame: at Week 24
Change From Baseline in Average Daily Rescue Ventolin HFA Use
Change from Baseline in Mean Daily Number of Puffs of Rescue Ventolin HFA for The Efficacy Estimand
Time frame: over 24 Weeks
Time to Onset of Action on Day 1, 5 Minutes Post Dose
FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand
Time frame: Day 1
Time to Onset of Action on Day 1, 15 Minutes Post Dose
FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand
Time frame: Day 1
Time to Onset of Action on Day 1, 30 Minutes Post Dose
FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand
Time frame: Day 1
Time to Onset of Action on Day 1, 1 Hour Post Dose
FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand
Time frame: Day 1
Time to Onset of Action on Day 1, 2 Hours Post Dose
FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand
Time frame: Day 1
Time to Onset of Action on Day 1, 4 Hours Post Dose
FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand
Time frame: Day 1
This study was conducted at 208 sites in four countries, from August 2015 until January 2018. The entire study period could take up to a maximum of 30 weeks.
| Milestone | BGF MDI 320/14.4/9.6 ug | GFF MDI 14.4/9.6 ug | BFF MDI 320/9.6 ug | Symbicort TBH 400/12 ug |
|---|---|---|---|---|
| Started | 640 | 627 | 316 | 319 |
| Completed | 566 | 524 | 266 | 278 |
| Not completed | 74 | 103 | 50 | 41 |
| Withdrew: Lost to follow-up | 10 | 2 | 0 | 2 |
| Withdrew: Adverse event | 28 | 30 | 11 | 11 |
| Withdrew: Withdrawal by subject | 14 | 37 | 19 | 15 |
| Withdrew: Physician decision | 5 | 11 | 5 | 1 |
| Withdrew: Subjects that were not treated | 1 | 2 | 2 | 1 |
| Withdrew: Major protocol deviation | 3 | 4 | 4 | 4 |
| Withdrew: Lack of efficacy | 10 | 16 | 6 | 6 |
| Withdrew: Protocol violation | 3 | 1 | 3 | 1 |
FEV1 AUC0-4 (L) for The Efficacy Estimand (Change from baseline in forced expiratory volume in 1 second (FEV1) area under the curve from 0 to 4 hours (AUC0-4) AUC was normalized for length of follow up (e.g. typically 4 hours)).
| Liters | BGF MDI 320/14.4/9.6 μg | GFF MDI (PT003) 14.4/9.6 μg | BFF MDI (PT009) 320/9.6 μg | Symbicort® |
|---|---|---|---|---|
| FEV1 AUC0-4 | 0.292 (0.271 to 0.314) | 0.288 (0.266 to 0.310) | 0.177 (0.146 to 0.207) | 0.189 (0.160 to 0.219) |
Morning Pre-Dose Trough FEV1 (L) for The Efficacy Estimand
| Liters | BGF MDI 320/14.4/9.6 μg | GFF MDI (PT003) 14.4/9.6 μg | BFF MDI (PT009) 320/9.6 μg | Symbicort® |
|---|---|---|---|---|
| Change From Baseline in Morning Pre-dose Trough FEV1 | 0.124 (0.108 to 0.140) | 0.111 (0.094 to 0.127) | 0.050 (0.027 to 0.072) | 0.062 (0.039 to 0.084) |
Morning Pre-Dose Trough FEV1 (L) for The Efficacy Estimand
| Liters | BGF MDI 320/14.4/9.6 μg | GFF MDI (PT003) 14.4/9.6 μg | BFF MDI (PT009) 320/9.6 μg | Symbicort® |
|---|---|---|---|---|
| Change From Baseline in Morning Pre-dose Trough FEV1 | 0.147 (0.134 to 0.159) | 0.125 (0.112 to 0.137) | 0.073 (0.055 to 0.091) | 0.088 (0.070 to 0.105) |
Peak Change from Baseline in FEV1 (L) Within 4 Hours Post-Dose for The Efficacy Estimand
| Liters | BGF MDI 320/14.4/9.6 μg | GFF MDI (PT003) 14.4/9.6 μg | BFF MDI (PT009) 320/9.6 μg | Symbicort® |
|---|---|---|---|---|
| Peak Change From Baseline in FEV1 Within 4 Hours Post-dosing | 0.370 (0.348 to 0.393) | 0.361 (0.338 to 0.384) | 0.253 (0.221 to 0.284) | 0.264 (0.233 to 0.295) |
Rate of Moderate or Severe COPD Exacerbations for the Efficacy Estimand
| Exacerbations | BGF MDI 320/14.4/9.6 μg | GFF MDI (PT003) 14.4/9.6 μg | BFF MDI (PT009) 320/9.6 μg | Symbicort® |
|---|---|---|---|---|
| Rate of Moderate or Severe COPD Exacerbations | 0.46 ± 0.05 | 0.95 ± 0.09 | 0.56 ± 0.08 | 0.55 ± 0.08 |
Change from BGF
| Percentage | GFF MDI (PT003) 14.4/9.6 μg | BFF MDI (PT009) 320/9.6 μg | Symbicort® |
|---|---|---|---|
| Percentage of Subjects Achieving a Minimal Clinically Important Difference (MCID) of 4 Units or More in SGRQ Total Score (SGRQ Responders) | 6.06 (0.30 to 11.82) | 6.43 (-0.62 to 13.47) | 8.23 (1.23 to 15.22) |
Change from Baseline in Mean Daily Number of Puffs of Rescue Ventolin HFA for The Efficacy Estimand
| Puffs | BGF MDI 320/14.4/9.6 μg | GFF MDI (PT003) 14.4/9.6 μg | BFF MDI (PT009) 320/9.6 μg | Symbicort® |
|---|---|---|---|---|
| Change From Baseline in Average Daily Rescue Ventolin HFA Use | -1.3 (-1.6 to -1.1) | -1.1 (-1.3 to -0.8) | -1.1 (-1.5 to -0.8) | -1.6 (-1.9 to -1.2) |
FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand
| Liters | BGF MDI 320/14.4/9.6 μg | GFF MDI (PT003) 14.4/9.6 μg | BFF MDI (PT009) 320/9.6 μg | Symbicort® |
|---|---|---|---|---|
| Time to Onset of Action on Day 1, 5 Minutes Post Dose | 0.181 (0.169 to 0.192) | 0.194 (0.182 to 0.205) | 0.167 (0.152 to 0.182) | 0.163 (0.148 to 0.178) |
FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand
| Liters | BGF MDI 320/14.4/9.6 μg | GFF MDI (PT003) 14.4/9.6 μg | BFF MDI (PT009) 320/9.6 μg | Symbicort® |
|---|---|---|---|---|
| Time to Onset of Action on Day 1, 15 Minutes Post Dose | 0.217 (0.205 to 0.230) | 0.230 (0.218 to 0.243) | 0.197 (0.180 to 0.213) | 0.190 (0.174 to 0.207) |
FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand
| Liters | BGF MDI 320/14.4/9.6 μg | GFF MDI (PT003) 14.4/9.6 μg | BFF MDI (PT009) 320/9.6 μg | Symbicort® |
|---|---|---|---|---|
| Time to Onset of Action on Day 1, 30 Minutes Post Dose | 0.236 (0.223 to 0.249) | 0.255 (0.242 to 0.268) | 0.213 (0.195 to 0.230) | 0.208 (0.190 to 0.225) |
FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand
| Liters | BGF MDI 320/14.4/9.6 μg | GFF MDI (PT003) 14.4/9.6 μg | BFF MDI (PT009) 320/9.6 μg | Symbicort® |
|---|---|---|---|---|
| Time to Onset of Action on Day 1, 1 Hour Post Dose | 0.268 (0.254 to 0.282) | 0.282 (0.268 to 0.296) | 0.228 (0.208 to 0.247) | 0.232 (0.213 to 0.251) |
FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand
| Liters | BGF MDI 320/14.4/9.6 μg | GFF MDI (PT003) 14.4/9.6 μg | BFF MDI (PT009) 320/9.6 μg | Symbicort® |
|---|---|---|---|---|
| Time to Onset of Action on Day 1, 2 Hours Post Dose | 0.281 (0.266 to 0.295) | 0.292 (0.277 to 0.307) | 0.241 (0.220 to 0.261) | 0.244 (0.224 to 0.265) |
FEV1 (L) by Post-Dose Timepoint on Day 1 for The Efficacy Estimand
| Liters | BGF MDI 320/14.4/9.6 μg | GFF MDI (PT003) 14.4/9.6 μg | BFF MDI (PT009) 320/9.6 μg | Symbicort® |
|---|---|---|---|---|
| Time to Onset of Action on Day 1, 4 Hours Post Dose | 0.276 (0.260 to 0.292) | 0.278 (0.262 to 0.294) | 0.234 (0.213 to 0.256) | 0.247 (0.225 to 0.268) |
Collected over Serious Adverse events were collected from the time subject signed Informed Consent to the time of the final follow-up telephone call. Adverse Events were collected from the time subject was randomized.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BGF MDI 320/14.4/9.6 ug | 6/639 (0.9%) | 55/639 (8.6%) | 126/639 (19.7%) |
| GFF MDI 14.4/9.6 ug | 3/625 (0.5%) | 68/625 (10.9%) | 84/625 (13.4%) |
| BFF MDI 320/9.6 ug | 2/314 (0.6%) | 21/314 (6.7%) | 59/314 (18.8%) |
| Symbicort TBH 400/12 ug | 1/318 (0.3%) | 29/318 (9.1%) | 55/318 (17.3%) |
| Event | BGF MDI 320/14.4/9.6 ug | GFF MDI 14.4/9.6 ug | BFF MDI 320/9.6 ug | Symbicort TBH 400/12 ug |
|---|---|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 17/639 | 32/625 | 8/314 | 13/318 |
| PneumoniaInfections and infestations | 8/639 | 6/625 | 1/314 | 0/318 |
| Acute respiratory failureRespiratory, thoracic and mediastinal disorders | 4/639 | 1/625 | 0/314 | 1/318 |
| Acute myocardial infarctionCardiac disorders | 1/639 | 2/625 | 1/314 | 1/318 |
| Inguinal herniaGastrointestinal disorders | 0/639 | 2/625 | 0/314 | 0/318 |
| PneumothoraxRespiratory, thoracic and mediastinal disorders | 2/639 | 1/625 | 1/314 | 1/318 |
| Pulmonary massRespiratory, thoracic and mediastinal disorders | 0/639 | 0/625 | 1/314 | 0/318 |
| SepsisInfections and infestations | 1/639 | 1/625 | 1/314 | 1/318 |
| InfluenzaInfections and infestations | 0/639 | 1/625 | 1/314 | 0/318 |
| Pyelonephritis acuteInfections and infestations | 0/639 | 0/625 | 1/314 | 0/318 |
| Event | BGF MDI 320/14.4/9.6 ug | GFF MDI 14.4/9.6 ug | BFF MDI 320/9.6 ug | Symbicort TBH 400/12 ug |
|---|---|---|---|---|
| Upper Respiratory InfectionInfections and infestations | 65/639 | 37/625 | 18/314 | 22/318 |
| NasopharyngititsInfections and infestations | 49/639 | 41/625 | 26/314 | 30/318 |
| Muscle SpasmsMusculoskeletal and connective tissue disorders | 21/639 | 8/625 | 17/314 | 6/318 |
mITT - Modified Intent to Treat
| Age, Continuous(Years) | BGF MDI 320/14.4/9.6 ug | GFF MDI 14.4/9.6 ug | BFF MDI 320/9.6 ug | Symbicort TBH 400/12 ug | Total |
|---|---|---|---|---|---|
| Mean | 64.9 ± 7.8 | 65.1 ± 7.7 | 65.2 ± 7.2 | 65.9 ± 7.7 | 65.2 ± 7.7 |
| Sex: Female, Male(Participants) | BGF MDI 320/14.4/9.6 ug | GFF MDI 14.4/9.6 ug | BFF MDI 320/9.6 ug | Symbicort TBH 400/12 ug | Total |
|---|---|---|---|---|---|
| Female | 179 | 195 | 90 | 82 | 546 |
| Male | 460 | 430 | 224 | 236 | 1350 |
| Ethnicity (NIH/OMB)(Participants) | BGF MDI 320/14.4/9.6 ug | GFF MDI 14.4/9.6 ug | BFF MDI 320/9.6 ug | Symbicort TBH 400/12 ug | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 16 | 14 | 7 | 4 | 41 |
| Not Hispanic or Latino | 623 | 611 | 305 | 312 | 1851 |
| Unknown or Not Reported | 0 | 0 | 2 | 2 | 4 |
| Race (NIH/OMB)(Participants) | BGF MDI 320/14.4/9.6 ug | GFF MDI 14.4/9.6 ug | BFF MDI 320/9.6 ug | Symbicort TBH 400/12 ug | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 0 | 0 | 1 |
| Asian | 284 | 285 | 142 | 141 | 852 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 0 | 0 | 1 |
| Black or African American | 23 | 38 | 15 | 14 | 90 |
| White | 329 | 301 | 157 | 163 | 950 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 2 | 0 | 0 | 0 | 2 |
Showing the first 100 of 190 sites across 4 countries. Choose a country and city above to see the rest.
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes
Ran from Aug 2015 to primary completion in Jan 2018, 28 months.
Results were first posted in Dec 2020, 2 years 11 months after primary completion. A results delay was requested in Feb 2019.
Of 108 industry-sponsored phase 3 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 36. This study's 28 months is above that.
Counting every sponsor, half of 141 studies reached it within 23 months; a quarter within 14 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drugs tested here: Budesonide · Glycopyrrolate · Formoterol
Pulmonary Disease, Chronic Obstructive →