CompletedNCT06644924MITCHELLUpdated Aug 27, 2026Results posted

A Study Evaluating the Effect of Inhaled PT007(AS MDI) Versus Placebo MDI and Ventolin Evohaler on Lung Function in Adult Participants With Asthma

A Phase 2 interventional study of Intervention: AS MDI and Intervention: Ventolin Evohaler in Asthma, sponsored by AstraZeneca. Completed at 22 sites in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-27.

Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment

Phase: Phase 2
Study type: Interventional
Enrollment: 118
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

Phase II study, to investigate the therapeutic efficacy and safety of inhaled PT007 (referred to as AS MDI) compared with placebo MDI and open-label Ventolin Evohaler in male and female participants aged 18 to 65 years (inclusive) with asthma.

This study consists of a screening/run-in period, a treatment period, and a follow-up phone call.

Read the detailed description

This is a randomized, double-blind, single-dose, placebo-controlled, 3-period, 3-treatment, crossover, multicenter study to assess the bronchodilatory effect and safety of AS MDI (180 μg) compared with placebo MDI and open-label Ventolin Evohaler (200 μg) in adult participants (aged 18 to 65 years, inclusive) with asthma (pre-bronchodilator FEV1 of ≥ 40% of the predicted normal value) and demonstrated FEV1 reversibility to Ventolin hydrofluoroalkane (HFA) (improvement in FEV1 at 30 minutes post-Ventolin HFA dosing of ≥ 12% and ≥ 200 mL).

The study duration will be a minimum of 15 days and up to a maximum of 52 days.

Including:

screening/run-in period: 3 to 28 days treatment period: 9 to 17 days follow-up phone call: 3 to 7 days after the final dose of study intervention

Eligible participants will be randomized to 1 of 6 predefined treatment sequences in a 1:1:1:1:1:1 ratio. Each sequence will contain AS MDI, placebo MDI, and Ventolin Evohaler in a randomized order.

Eligible participants will receive a single dose of randomized study intervention at each of 3 treatment visits (Visits 2, 3, and 4), with a 3- to 7-day washout period between treatment visits.

Conditions studied

Asthma

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Keywords

Asthma, Bronchial
Bronchial Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Anti-Asthmatic Agents
Respiratory System Agents

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Inclusion Criteria:

Age

Participant must be aged 18 to 65 years (inclusive), at the time of signing the informed consent.
Type of Participant and Disease Characteristics
Participants should have a documented history of physician-diagnosed asthma ≥ 6 months prior to Visit 1.
Must be receiving one of the following required inhaled asthma therapies listed below for at least the last 30 days:
1. Only SABA, which is used as needed for rescue.
2. Low to medium doses of ICS (alone or in combination with LABA), used regularly as maintenance asthma therapy.
Pre-BD FEV1 of ≥ 40% of the PN value at Visit 1, after withholding SABA for ≥ 6 hours (and Visit 1a and/or Visit 1b, if applicable).
Confirmed FEV1 reversibility to 4 actuations of Ventolin HFA, defined as a post-Ventolin HFA increase in FEV1 at 30 minutes of ≥ 12% and ≥ 200 mL at either Visit 1, Visit 1a, or Visit 1b; only 2 reversibility testing attempts are allowed.
Demonstrate acceptable spirometry performance (ie, meet ATS/ERS acceptability/repeatability criteria).
Willing and, in the opinion of the investigator, able to adjust current asthma therapy, as required by the protocol.
Demonstrate acceptable MDI administration technique. Note: Use of a spacer device during the screening and randomized treatment periods is not permitted.
Weight
Body mass index \< 40 kg/m2. Sex and Contraceptive/Barrier Requirements
Contraceptive use by females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Female participants: A participant of childbearing potential, must have a negative urine pregnancy test at Visit 1 (to be read locally).
Participants not of childbearing potential are defined as those who are physiologically incapable of becoming pregnant, including any participant who is 2 years postmenopausal, or surgically sterile (defined as having a bilateral oophorectomy, hysterectomy, tubal ligation, or other permanent birth control measures).
Participants aged ≥ 50 years will be considered postmenopausal if they have been amenorrheic for 12 consecutive months or more following cessation of all exogenous hormonal treatment.
Participants aged \< 50 years will be considered postmenopausal if they have been amenorrheic for 12 consecutive months or more following cessation of exogenous hormonal treatment and in the absence of any alternative medical cause, as judged by the investigator.
Participants of childbearing potential must use a highly effective form of contraception from signing of the ICF to 14 days after the last study intervention. Highly effective birth control methods are listed below:
Total sexual abstinence is an acceptable method provided it is the usual lifestyle of the participant (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments).
Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation):
- Oral
- Intravaginal (eg, NuvaRing®)
- Transdermal (eg, Evra Patch™, Xulane™)
Progestogen-only hormonal contraception associated with inhibition of ovulation:
- Oral
- Injectable (eg, Depo-Provera™)
- Implantable (eg, Implanon®) Intrauterine device or intrauterine hormone-releasing system Bilateral tubal occlusion Male partner sterilization/vasectomy with documentation of azoospermia prior to the female participant's entry into the study, and this male is the sole partner for that participant. The documentation on male sterility can come from the site personnel's review of participant's medical records, medical examination and/or semen analysis, or medical history interview provided by her or her partner.
Note: Periodic abstinence (calendar, ovulation, symptothermal, post-ovulation methods), withdrawal (coitus interruptus), declaration of abstinence for the duration of exposure to study intervention, spermicides only, and lactational amenorrhea method are not acceptable methods of contraception.
Informed Consent
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
Other Inclusion Criteria
Compliance: must be willing to remain at the study site as required per protocol to complete all visit assessments.

Exclusion Criteria:

5.2 Exclusion Criteria

Participants are excluded from the study if any of the following criteria apply:

Medical Conditions and History

Any evidence of chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the participant at risk through participation, or that could affect the efficacy or safety analysis.
Life-threatening asthma defined as any history of significant asthma episode(s) requiring intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma-related syncopal episode(s) within the last 5 years.
Upper respiratory infection not resolved within 7 days of Visit 1 and throughout the screening period.
Hospitalizations for asthma exacerbation within the last 3 months prior to Visit 1.
Historical or current evidence of a clinically significant disease including, but not limited to: cardiovascular (eg, congestive heart failure, known aortic aneurysm, clinically significant cardiac arrhythmia, participants with known QTcF ≥ 480 ms, coronary heart disease), hepatic, renal, hematological, neuropsychological, endocrine (eg, uncontrolled diabetes mellitus, uncontrolled thyroid disorder, Addison's disease, Cushing's syndrome), or gastrointestinal (eg, poorly controlled peptic ulcer, gastroesophageal reflux disease). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the participant at risk through study participation, or that could affect the efficacy or safety analysis if the disease/condition exacerbated during the study.
Cancer not in complete remission for at least 5 years prior to Visit 1. Note: Participants with squamous cell carcinoma of the skin or basal cell carcinoma of the skin or cervical carcinoma in situ are eligible, if in the opinion of the investigator, the condition has been adequately worked up and clinically controlled, and the participant's participation in the study would not represent a safety concern.
Hospitalized for psychiatric disorder or attempted suicide within one year prior to Visit 1.
History of psychiatric disease, intellectual deficiency, poor motivation, or other conditions limiting informed consent validity.
Received a live attenuated vaccination within 7 days of Visit 1. Prior/Concomitant Therapy
Oral/systemic corticosteroid use (any dose) within 6 weeks of Visit 1.
Chronic use of oral corticosteroids (≥ 3 weeks use in the 3 months prior to Visit 1).
Received any marketed (eg, omalizumab, mepolizumab, reslizumab) or investigational biologic within 3 months or 5 half-lives, whichever is longer, or any other medication specifically prohibited by the protocol within the indicated exclusionary time periods.
Received tiotropium within 2 weeks of Visit 1.
Received treatment for lower respiratory infection or asthma exacerbation within 6 weeks of Visit 1.
Unable to abstain from protocol-defined prohibited medications during screening and the study.
Using any herbal products by inhalation or nebulizer within 2 weeks of Visit 1 and does not agree to stop during the study duration.
Prior/Concurrent Clinical Study Experience
Treatment with investigational study intervention (or device) in another clinical study within the last 30 days or 5 half-lives, whichever is longer, prior to Visit 1.
Hypersensitivity to β2-agonists or any component of the investigational MDI or any component of Ventolin Evohaler or HFA (or Pulmicort Flexhaler, if applicable).
Other Exclusions
Significant abuse of alcohol or drugs in the opinion of the investigator.
Current smokers, former smokers with > 10 pack-years history, or former smokers who stopped smoking \< 6 months (including all forms of tobacco, e-cigarettes [vaping], and marijuana).
Study investigators, sub-investigators, coordinators, and their employees or immediate family members, or employees of the sponsor.
Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
For female participants only: currently pregnant (confirmed with positive pregnancy test) or breastfeeding.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment: 118 participants (actual)

Study arms

Experimental
Treatment Sequence 1
Participants will be randomized to 1 of the 6 different treatment sequences. Each treatment sequence consist of Treatment A (Ventolin Evohaler) , Treatment B (Placebo MDI), and Treatment C (Albuterol Sulfate metered dose inhaler \[AS MDI\] - PT007).
Combination Product: Intervention: AS MDI · Combination Product: Intervention: Ventolin Evohaler · Combination Product: Intervention: Placebo matching AS MDI
Experimental
Treatment Sequence 2
Participants will be randomized to 1 of the 6 different treatment sequences. Each treatment sequence consist of Treatment C (Albuterol Sulfate metered dose inhaler \[AS MDI\] - PT007), Treatment A (Ventolin Evohaler) and Treatment B (Placebo MDI).
Combination Product: Intervention: AS MDI · Combination Product: Intervention: Ventolin Evohaler · Combination Product: Intervention: Placebo matching AS MDI
Experimental
Treatment Sequence 3
Participants will be randomized to 1 of the 6 different treatment sequences. Each treatment sequence consist of Treatment B (Placebo MDI), Treatment C (Albuterol Sulfate metered dose inhaler \[AS MDI\] - PT007), Treatment A (Ventolin Evohaler).
Combination Product: Intervention: AS MDI · Combination Product: Intervention: Ventolin Evohaler · Combination Product: Intervention: Placebo matching AS MDI
Experimental
Treatment Sequence 4
Participants will be randomized to 1 of the 6 different treatment sequences. Each treatment sequence consist of Treatment C (Albuterol Sulfate metered dose inhaler \[AS MDI\] - PT007), Treatment B (Placebo MDI), Treatment A (Ventolin Evohaler).
Combination Product: Intervention: AS MDI · Combination Product: Intervention: Ventolin Evohaler · Combination Product: Intervention: Placebo matching AS MDI
Experimental
Treatment Sequence 5
Participants will be randomized to 1 of the 6 different treatment sequences. Each treatment sequence consist of Treatment B (Placebo MDI), Treatment A (Ventolin Evohaler), and Treatment C (Albuterol Sulfate metered dose inhaler \[AS MDI\] - PT007).
Combination Product: Intervention: AS MDI · Combination Product: Intervention: Ventolin Evohaler · Combination Product: Intervention: Placebo matching AS MDI
Experimental
Treatment Sequence 6
Participants will be randomized to 1 of the 6 different treatment sequences. Each treatment sequence consist of Treatment A (Ventolin Evohaler), Treatment C (Albuterol Sulfate metered dose inhaler \[AS MDI\] - PT007) and Treatment B (Placebo MDI).
Combination Product: Intervention: AS MDI · Combination Product: Intervention: Ventolin Evohaler · Combination Product: Intervention: Placebo matching AS MDI

Interventions

Combination productIntervention: AS MDI
Drug Treatment: (Albuterol Sulfate metered dose inhaler \[AS MDI\] - PT007) Randomized participants will receive a single-dose (2 inhalations)
Also known as: Albuterol Sulfate metered dose inhaler [AS MDI] - PT007)
Combination productIntervention: Ventolin Evohaler
Drug: Treatment (Ventolin Evohaler) Randomized participants will receive a single-dose (2 inhalations)
Combination productIntervention: Placebo matching AS MDI
Drug: Treatment (Placebo MDI) Randomized participants will receive a single-dose (2 inhalations to match AS MDI)

What researchers measure

Primary outcomes

Change From Baseline in FEV1 AUC 0-6 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Non-inferiority Analysis
Change from baseline FEV1 measured at each time point for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values. Area Under the Curve (AUC) 0-6 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., \~ 6 hours).
Time frame: 0 to 6 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose)
Change From Baseline in FEV1 AUC 0-6 Hours (mL) for Ventolin Evohaler Compared With Placebo - Superiority Analysis
Change from baseline in FEV1 measured at each time point for Ventolin Evohaler and Placebo. Baseline FEV1 is the period specific mean of the available pre-dose values. AUC 0-6 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., \~ 6 hours).
Time frame: 0 to 6 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose)

Secondary outcomes

Change From Baseline in FEV1 AUC 0-6 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Equivalence Analysis
Change from baseline FEV1 measured at each time point for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values. AUC 0-6 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., \~ 6 hours).
Time frame: 0 to 6 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose)
Change From Baseline in FEV1 AUC 0-4 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Non-inferiority Analysis
Change from baseline FEV1 measured at each time point for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values. AUC 0-4 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., \~ 4 hours).
Time frame: 0 to 4 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose)
Change From Baseline in FEV1 AUC 0-4 Hours (mL) for Ventolin Evohaler Compared With Placebo - Superiority Analysis
Change from baseline FEV1 measured at each time point for Ventolin Evohaler and Placebo. Baseline FEV1 is the period specific mean of the available pre-dose values. AUC 0-4 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., \~ 4 hours).
Time frame: 0 to 4 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose)
Change From Baseline in FEV1 AUC 0-4 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Equivalence Analysis
Change from baseline FEV1 measured at each time point for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values. AUC 0-4 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., \~ 4 hours).
Time frame: 0 to 4 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose)
Peak Change From Baseline in FEV1 (mL) for AS MDI Relative to Ventolin Evohaler - Non-inferiority Analysis
Peak change from baseline in FEV1 is the difference between the maximum FEV1 value measured during the 6 hour post dose period and the baseline FEV1 for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values.
Time frame: 0 to 6 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose)
Peak Change From Baseline in FEV1 (mL) for Ventolin Evohaler Compared With Placebo - Superiority Analysis
Peak change from baseline in FEV1 is the difference between the maximum FEV1 value measured during the 6 hour post dose period and the baseline FEV1 for Ventolin Evohaler and Placebo. Baseline FEV1 is the period specific mean of the available pre-dose values.
Time frame: 0 to 6 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose)
Peak Change From Baseline in FEV1 (mL) for AS MDI Relative to Ventolin Evohaler - Equivalence Analysis
Peak change from baseline in FEV1 is the difference between the maximum FEV1 value measured during the 6 hour post dose period and the baseline FEV1 for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values.
Time frame: 0 to 6 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose)

Results

Posted Aug 27, 2026

Participant flow

This study was conducted at 23 sites in the United States, from February 2025 to May 2025. The study was anticipated to run for at least 15 days but not to exceed 52 days.

Treatment Period 1

Participant flow — Treatment Period 1
Milestone	Treatment Sequence 1 - Ventolin Evohaler 200 μg \| Placebo \| AS MDI 180 μg	Treatment Sequence 2 - AS MDI 180 μg \| Ventolin Evohaler 200 μg \| Placebo	Treatment Sequence 3 - Placebo \| AS MDI 180 μg \| Ventolin Evohaler 200 μg	Treatment Sequence 4 - AS MDI 180 μg \| Placebo \| Ventolin Evohaler 200 μg	Treatment Sequence 5 - Placebo \| Ventolin Evohaler 200 μg \| AS MDI 180 μg	Treatment Sequence 6 - Ventolin Evohaler 200 μg \| AS MDI 180 μg \| Placebo
Started	20	19	19	19	21	20
Completed	20	18	18	18	18	19
Not completed	0	1	1	1	3	1
Withdrew: The subject left town for a job out of town and would not be able to attend study visits.	0	0	0	1	0	0
Withdrew: Withdrawal by subject	0	0	0	0	1	0
Withdrew: Physician decision	0	0	1	0	0	1
Withdrew: Adverse event	0	0	0	0	1	0
Withdrew: Protocol violation	0	1	0	0	1	0

Treatment Period 2

Participant flow — Treatment Period 2
Milestone	Treatment Sequence 1 - Ventolin Evohaler 200 μg \| Placebo \| AS MDI 180 μg	Treatment Sequence 2 - AS MDI 180 μg \| Ventolin Evohaler 200 μg \| Placebo	Treatment Sequence 3 - Placebo \| AS MDI 180 μg \| Ventolin Evohaler 200 μg	Treatment Sequence 4 - AS MDI 180 μg \| Placebo \| Ventolin Evohaler 200 μg	Treatment Sequence 5 - Placebo \| Ventolin Evohaler 200 μg \| AS MDI 180 μg	Treatment Sequence 6 - Ventolin Evohaler 200 μg \| AS MDI 180 μg \| Placebo
Started	20	18	18	18	18	19
Completed	20	18	17	17	18	18
Not completed	0	0	1	1	0	1
Withdrew: Withdrawal by subject	0	0	1	0	0	0
Withdrew: Adverse event	0	0	0	0	0	1
Withdrew: Protocol violation	0	0	0	1	0	0

Treatment Period 3

Participant flow — Treatment Period 3
Milestone	Treatment Sequence 1 - Ventolin Evohaler 200 μg \| Placebo \| AS MDI 180 μg	Treatment Sequence 2 - AS MDI 180 μg \| Ventolin Evohaler 200 μg \| Placebo	Treatment Sequence 3 - Placebo \| AS MDI 180 μg \| Ventolin Evohaler 200 μg	Treatment Sequence 4 - AS MDI 180 μg \| Placebo \| Ventolin Evohaler 200 μg	Treatment Sequence 5 - Placebo \| Ventolin Evohaler 200 μg \| AS MDI 180 μg	Treatment Sequence 6 - Ventolin Evohaler 200 μg \| AS MDI 180 μg \| Placebo
Started	20	18	17	17	18	18
Completed	20	18	17	17	18	18
Not completed	0	0	0	0	0	0

Outcome measures

SecondaryChange From Baseline in FEV1 AUC 0-6 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Equivalence Analysis

Change from baseline FEV1 measured at each time point for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values. AUC 0-6 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., \~ 6 hours).

Time frame:: 0 to 6 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose)
Reported as:: Least squares mean · milliliters (mL)

Change From Baseline in FEV1 AUC 0-6 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Equivalence Analysis
milliliters (mL)	AS MDI 180 μg	Ventolin Evohaler 200 μg
Change From Baseline in FEV1 AUC 0-6 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Equivalence Analysis	186.77 (146.73 to 226.81)	207.33 (167.29 to 247.38)

Statistical analysis

AS MDI 180 μg vs Ventolin Evohaler 200 μg · Difference in least square means: -20.56 · 90% CI -52.01 to 10.89The analysis was performed using a linear mixed-effects model. The dependent variable was the change from baseline in FEV1 AUC 0-6 hours (mL).

SecondaryChange From Baseline in FEV1 AUC 0-4 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Non-inferiority Analysis

Change from baseline FEV1 measured at each time point for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values. AUC 0-4 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., \~ 4 hours).

Time frame:: 0 to 4 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose)
Reported as:: Least squares mean · milliliters (mL)

Change From Baseline in FEV1 AUC 0-4 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Non-inferiority Analysis
milliliters (mL)	AS MDI 180 μg	Ventolin Evohaler 200 μg
Change From Baseline in FEV1 AUC 0-4 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Non-inferiority Analysis	228.32 (186.06 to 270.57)	248.77 (206.51 to 291.03)

Statistical analysis

AS MDI 180 μg vs Ventolin Evohaler 200 μg · Difference in least square means: -20.46 · 90% CI -52.16 to 11.24The analysis was performed using a linear mixed-effects model. The dependent variable was the change from baseline in FEV1 AUC 0-4 hours (mL).

SecondaryChange From Baseline in FEV1 AUC 0-4 Hours (mL) for Ventolin Evohaler Compared With Placebo - Superiority Analysis

Change from baseline FEV1 measured at each time point for Ventolin Evohaler and Placebo. Baseline FEV1 is the period specific mean of the available pre-dose values. AUC 0-4 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., \~ 4 hours).

Time frame:: 0 to 4 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose)
Reported as:: Least squares mean · milliliters (mL)

Change From Baseline in FEV1 AUC 0-4 Hours (mL) for Ventolin Evohaler Compared With Placebo - Superiority Analysis
milliliters (mL)	Ventolin Evohaler 200 μg	Placebo
Change From Baseline in FEV1 AUC 0-4 Hours (mL) for Ventolin Evohaler Compared With Placebo - Superiority Analysis	246.34 (208.97 to 283.72)	69.15 (31.78 to 106.52)

Statistical analysis

Ventolin Evohaler 200 μg vs Placebo · Linear mixed effect model · p = <0.001 · Difference in least square means: 177.19 · 95% CI 132.96 to 221.42The analysis was performed using a linear mixed-effects model. The dependent variable was the change from baseline in FEV1 AUC 0-4 hours (mL).

SecondaryChange From Baseline in FEV1 AUC 0-4 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Equivalence Analysis

Time frame:: 0 to 4 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose)
Reported as:: Least squares mean · milliliters (mL)

Change From Baseline in FEV1 AUC 0-4 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Equivalence Analysis
milliliters (mL)	AS MDI 180 μg	Ventolin Evohaler 200 μg
Change From Baseline in FEV1 AUC 0-4 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Equivalence Analysis	228.32 (186.06 to 270.57)	248.77 (206.51 to 291.03)

Statistical analysis

AS MDI 180 μg vs Ventolin Evohaler 200 μg · Difference in least square means: -20.46 · 90% CI -52.16 to 11.24The analysis was performed using a linear mixed-effects model. The dependent variable was the change from baseline in FEV1 AUC 0-4 hours (mL).

SecondaryPeak Change From Baseline in FEV1 (mL) for AS MDI Relative to Ventolin Evohaler - Non-inferiority Analysis

Peak change from baseline in FEV1 is the difference between the maximum FEV1 value measured during the 6 hour post dose period and the baseline FEV1 for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values.

Time frame:: 0 to 6 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose)
Reported as:: Least squares mean · milliliters (mL)

Peak Change From Baseline in FEV1 (mL) for AS MDI Relative to Ventolin Evohaler - Non-inferiority Analysis
milliliters (mL)	AS MDI 180 μg	Ventolin Evohaler 200 μg
Peak Change From Baseline in FEV1 (mL) for AS MDI Relative to Ventolin Evohaler - Non-inferiority Analysis	384.54 (330.04 to 439.05)	434.03 (379.51 to 488.54)

Statistical analysis

AS MDI 180 μg vs Ventolin Evohaler 200 μg · Difference in least square means: -49.48 · 90% CI -91.17 to -7.80The analysis was performed using a linear mixed-effects model. The dependent variable was the peak change from baseline in FEV1 (mL).

SecondaryPeak Change From Baseline in FEV1 (mL) for Ventolin Evohaler Compared With Placebo - Superiority Analysis

Peak change from baseline in FEV1 is the difference between the maximum FEV1 value measured during the 6 hour post dose period and the baseline FEV1 for Ventolin Evohaler and Placebo. Baseline FEV1 is the period specific mean of the available pre-dose values.

Time frame:: 0 to 6 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose)
Reported as:: Least squares mean · milliliters (mL)

Peak Change From Baseline in FEV1 (mL) for Ventolin Evohaler Compared With Placebo - Superiority Analysis
milliliters (mL)	Ventolin Evohaler 200 μg	Placebo
Peak Change From Baseline in FEV1 (mL) for Ventolin Evohaler Compared With Placebo - Superiority Analysis	433.43 (382.76 to 484.10)	235.59 (184.93 to 286.24)

Statistical analysis

Ventolin Evohaler 200 μg vs Placebo · Linear mixed effect model · p = <0.001 · Difference in least square means: 197.84 · 95% CI 135.80 to 259.88The analysis was performed using a linear mixed-effects model. The dependent variable was peak change from baseline in FEV1 (mL).

SecondaryPeak Change From Baseline in FEV1 (mL) for AS MDI Relative to Ventolin Evohaler - Equivalence Analysis

Time frame:: 0 to 6 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose)
Reported as:: Least squares mean · milliliters (mL)

Peak Change From Baseline in FEV1 (mL) for AS MDI Relative to Ventolin Evohaler - Equivalence Analysis
milliliters (mL)	AS MDI 180 μg	Ventolin Evohaler 200 μg
Peak Change From Baseline in FEV1 (mL) for AS MDI Relative to Ventolin Evohaler - Equivalence Analysis	384.54 (330.04 to 439.05)	434.03 (379.51 to 488.54)

Statistical analysis

AS MDI 180 μg vs Ventolin Evohaler 200 μg · Difference in least square means: -49.48 · 90% CI -91.17 to -7.80The analysis was performed using a linear mixed-effects model. The dependent variable was the peak change from baseline in FEV1 (mL).

PrimaryChange From Baseline in FEV1 AUC 0-6 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Non-inferiority Analysis

Change from baseline FEV1 measured at each time point for AS MDI and Ventolin Evohaler. Baseline FEV1 is the period specific mean of the available pre-dose values. Area Under the Curve (AUC) 0-6 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., \~ 6 hours).

Time frame:: 0 to 6 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose)
Reported as:: Least squares mean · milliliters (mL)

Change From Baseline in FEV1 AUC 0-6 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Non-inferiority Analysis
milliliters (mL)	AS MDI 180 μg	Ventolin Evohaler 200 μg
Change From Baseline in FEV1 AUC 0-6 Hours (mL) for AS MDI Relative to Ventolin Evohaler - Non-inferiority Analysis	186.77 (146.73 to 226.81)	207.33 (167.29 to 247.38)

Statistical analysis

AS MDI 180 μg vs Ventolin Evohaler 200 μg · Difference in least square means: -20.56 · 90% CI -52.01 to 10.89The analysis was performed using a linear mixed-effects model. The dependent variable was the change from baseline in FEV1 AUC 0-6 hours (mL).

PrimaryChange From Baseline in FEV1 AUC 0-6 Hours (mL) for Ventolin Evohaler Compared With Placebo - Superiority Analysis

Change from baseline in FEV1 measured at each time point for Ventolin Evohaler and Placebo. Baseline FEV1 is the period specific mean of the available pre-dose values. AUC 0-6 hours is calculated using the trapezoidal rule and normalized by dividing by the time in hours from dosing to the last measurement included (i.e., \~ 6 hours).

Time frame:: 0 to 6 hours (Spirometry will be obtained 60 and 30 minutes pre-dose and 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose)
Reported as:: Least squares mean · milliliters (mL)

Change From Baseline in FEV1 AUC 0-6 Hours (mL) for Ventolin Evohaler Compared With Placebo - Superiority Analysis
milliliters (mL)	Ventolin Evohaler 200 μg	Placebo
Change From Baseline in FEV1 AUC 0-6 Hours (mL) for Ventolin Evohaler Compared With Placebo - Superiority Analysis	205.27 (168.61 to 241.92)	67.84 (31.19 to 104.48)

Statistical analysis

Ventolin Evohaler 200 μg vs Placebo · Linear mixed effect model · p = <0.001 · Difference in least square means: 137.43 · 95% CI 92.67 to 182.19The analysis was performed using a linear mixed-effects model. The dependent variable was the change from baseline in FEV1 AUC 0-6 hours (mL).

Adverse events

Collected over On-treatment Adverse events include adverse events with an onset date on or 1 day after the dose of study intervention. This includes worsening of pre-existing events before randomisation.. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
AS MDI 180 μg	0/113 (0%)	0/113 (0%)	1/113 (0.9%)
Ventolin Evohaler 200 μg	0/110 (0%)	0/110 (0%)	1/110 (0.9%)
Placebo	0/114 (0%)	0/114 (0%)	1/114 (0.9%)

Most frequent other events

Most frequent other events
Event	AS MDI 180 μg	Ventolin Evohaler 200 μg	Placebo
DiarrhoeaGastrointestinal disorders	0/113	1/110	0/114
VomitingGastrointestinal disorders	0/113	1/110	0/114
Acute sinusitisInfections and infestations	1/113	0/110	0/114
Conjunctivitis bacterialInfections and infestations	0/113	0/110	1/114

Baseline characteristics

Participants in the Full Analysis Set (FAS) who were randomized to study intervention and received at least one inhalation of the study intervention.

Age, Continuous
Age, Continuous(Years)	Treatment Sequence 1 - Ventolin Evohaler 200 μg \| Placebo \| AS MDI 180 μg	Treatment Sequence 2 - AS MDI 180 μg \| Ventolin Evohaler 200 μg \| Placebo	Treatment Sequence 3 - Placebo \| AS MDI 180 μg \| Ventolin Evohaler 200 μg	Treatment Sequence 4 - AS MDI 180 μg \| Placebo \| Ventolin Evohaler 200 μg	Treatment Sequence 5 - Placebo \| Ventolin Evohaler 200 μg \| AS MDI 180 μg	Treatment Sequence 6 - Ventolin Evohaler 200 μg \| AS MDI 180 μg \| Placebo	Total
Age (years)	41.7 ± 11.6	44.4 ± 13.8	43.3 ± 11.7	44.6 ± 12.5	41.0 ± 13.2	47.1 ± 12.9	43.6 ± 12.5

Sex: Female, Male
Sex: Female, Male(Participants)	Treatment Sequence 1 - Ventolin Evohaler 200 μg \| Placebo \| AS MDI 180 μg	Treatment Sequence 2 - AS MDI 180 μg \| Ventolin Evohaler 200 μg \| Placebo	Treatment Sequence 3 - Placebo \| AS MDI 180 μg \| Ventolin Evohaler 200 μg	Treatment Sequence 4 - AS MDI 180 μg \| Placebo \| Ventolin Evohaler 200 μg	Treatment Sequence 5 - Placebo \| Ventolin Evohaler 200 μg \| AS MDI 180 μg	Treatment Sequence 6 - Ventolin Evohaler 200 μg \| AS MDI 180 μg \| Placebo	Total
Sex — Female	9	10	10	10	12	13	64
Sex — Male	11	9	9	9	9	7	54

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Treatment Sequence 1 - Ventolin Evohaler 200 μg \| Placebo \| AS MDI 180 μg	Treatment Sequence 2 - AS MDI 180 μg \| Ventolin Evohaler 200 μg \| Placebo	Treatment Sequence 3 - Placebo \| AS MDI 180 μg \| Ventolin Evohaler 200 μg	Treatment Sequence 4 - AS MDI 180 μg \| Placebo \| Ventolin Evohaler 200 μg	Treatment Sequence 5 - Placebo \| Ventolin Evohaler 200 μg \| AS MDI 180 μg	Treatment Sequence 6 - Ventolin Evohaler 200 μg \| AS MDI 180 μg \| Placebo	Total
Ethnicity — Hispanic or Latino	8	4	8	9	8	10	47
Ethnicity — Not Hispanic or Latino	12	15	11	10	13	10	71
Ethnicity — Unknown or Not Reported	0	0	0	0	0	0	0

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Treatment Sequence 1 - Ventolin Evohaler 200 μg \| Placebo \| AS MDI 180 μg	Treatment Sequence 2 - AS MDI 180 μg \| Ventolin Evohaler 200 μg \| Placebo	Treatment Sequence 3 - Placebo \| AS MDI 180 μg \| Ventolin Evohaler 200 μg	Treatment Sequence 4 - AS MDI 180 μg \| Placebo \| Ventolin Evohaler 200 μg	Treatment Sequence 5 - Placebo \| Ventolin Evohaler 200 μg \| AS MDI 180 μg	Treatment Sequence 6 - Ventolin Evohaler 200 μg \| AS MDI 180 μg \| Placebo	Total
Race — American Indian or Alaska Native	0	0	0	0	0	0	0
Race — Asian	0	0	0	0	0	0	0
Race — Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0
Race — Black or African American	3	8	6	4	6	5	32
Race — White	16	9	11	14	14	13	77
Race — More than one race	1	2	1	0	1	2	7
Race — Unknown or Not Reported	0	0	1	1	0	0	2

Lung function data at screening
Lung function data at screening(FEV1 (mL))	Treatment Sequence 1 - Ventolin Evohaler 200 μg \| Placebo \| AS MDI 180 μg	Treatment Sequence 2 - AS MDI 180 μg \| Ventolin Evohaler 200 μg \| Placebo	Treatment Sequence 3 - Placebo \| AS MDI 180 μg \| Ventolin Evohaler 200 μg	Treatment Sequence 4 - AS MDI 180 μg \| Placebo \| Ventolin Evohaler 200 μg	Treatment Sequence 5 - Placebo \| Ventolin Evohaler 200 μg \| AS MDI 180 μg	Treatment Sequence 6 - Ventolin Evohaler 200 μg \| AS MDI 180 μg \| Placebo	Total
Pre-bronchodilator FEV1 (mL)	2489.5 ± 740.4	2261.6 ± 824.9	2183.2 ± 583.4	2233.7 ± 627.4	2201.9 ± 682.9	2008.0 ± 571.9	2227.3 ± 677.3
Post-bronchodilator FEV1 (mL)	3057.4 ± 800.5	2851.6 ± 792.2	2715.8 ± 573.9	2830.0 ± 702.0	2741.0 ± 755.2	2582.0 ± 677.4	2793.5 ± 720.6

Bronchodilator responsiveness at screening
Bronchodilator responsiveness at screening(%)	Treatment Sequence 1 - Ventolin Evohaler 200 μg \| Placebo \| AS MDI 180 μg	Treatment Sequence 2 - AS MDI 180 μg \| Ventolin Evohaler 200 μg \| Placebo	Treatment Sequence 3 - Placebo \| AS MDI 180 μg \| Ventolin Evohaler 200 μg	Treatment Sequence 4 - AS MDI 180 μg \| Placebo \| Ventolin Evohaler 200 μg	Treatment Sequence 5 - Placebo \| Ventolin Evohaler 200 μg \| AS MDI 180 μg	Treatment Sequence 6 - Ventolin Evohaler 200 μg \| AS MDI 180 μg \| Placebo	Total
Mean	16.4 ± 3.8	18.8 ± 6.4	16.4 ± 6.4	18.6 ± 6.8	15.6 ± 3.0	18.7 ± 9.5	17.4 ± 6.3

Study locations

22 sites

Research Site
Encinitas, California 92024, United States
Research Site
Lancaster, California 93534, United States
Research Site
Los Angeles, California 90048, United States
Research Site
Newport Beach, California 92663, United States
Research Site
San Diego, California 92123, United States
Research Site
San Jose, California 95117, United States
Research Site
Stockton, California 95207, United States
Research Site
Clearwater, Florida 33765, United States
Research Site
Miami, Florida 33175, United States
Research Site
Tallahassee, Florida 32308, United States
Research Site
Tampa, Florida 33607, United States
Research Site
White Marsh, Maryland 21162, United States
Research Site
Columbia, Missouri 65203, United States
Research Site
Saint Charles, Missouri 63301, United States
Research Site
St Louis, Missouri 63141, United States
Research Site
Raleigh, North Carolina 27607, United States
Research Site
Medford, Oregon 97504, United States
Research Site
Portland, Oregon 97202, United States
Research Site
Austin, Texas 78759, United States
Research Site
El Paso, Texas 79912, United States
Research Site
Victoria, Texas 77901, United States
Research Site
Milwaukee, Wisconsin 53228, United States

References and documents

Study documents

Study protocol · Sep 10, 2024
Statistical analysis plan · Sep 10, 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 Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Supporting information: Study protocol, Sap

Registry details

Key details

Study ID: NCT06644924
Lead sponsor: AstraZeneca
Responsible party: Sponsor
First posted: Oct 16, 2024
Start date: Feb 10, 2025
Primary completion: Jun 4, 2025
Completion: Jun 4, 2025
Results posted: Aug 27, 2026
Last update: Aug 27, 2026

Oversight

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

View the source record on ClinicalTrials.gov ↗

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A Study Evaluating the Effect of Inhaled PT007(AS MDI) Versus Placebo MDI and Ventolin Evohaler on Lung Function in Adult Participants With Asthma

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