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
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Among 359 studies in Asthma by AstraZeneca — 19 open to participants now, 28 under way, 8 of them phase 3. Asthma · AstraZeneca.
Among the 359 studies in Asthma by AstraZeneca, this one is the 144th largest by enrollment of the 248 interventional ones that give a count, is one of 13 that started in 2025, is one of 50 in phase 2, and was the 334th registered.
4,846 studies on the registry are indexed under Asthma; 603 are open to participants now.
Browse Asthma studies →19 of the 359 studies in Asthma by AstraZeneca are open now, in 12 countries. Recruiting first, the newest first:
AstraZeneca · Sites in Korea, Republic of
AstraZeneca · Sites in China
AstraZeneca · Sites in United States, Argentina, Austria and 11 more countries
Ages 6+
AstraZeneca · Sites in China
Ages 18–75
AstraZeneca · Sites in United States, Argentina, Czechia and 4 more countries
Ages 4–11
By country, each count listing its studies:
Of the 417 Asthma studies recruiting now, 140 (34%) set no upper age limit and 205 (49%) stop at 75 or younger; 147 take children under 18; 105 take healthy volunteers.
This study: 18 Years to 65 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.
359 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 46 · Phase 2 52 · Phase 3 123 · Phase 4 23
First in 1996; this study’s year is marked. 13 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 118 is above the median of 79 across 3,344 interventional studies indexed under Asthma.
Median enrollment 175 across the 248 interventional studies, 500 across the 110 observational. Of the 330 that completed or were terminated, 129 (39%) have results posted.
This tab as a report to print or save as PDF → With an account.
AstraZeneca is the lead sponsor of 3,503 studies on the registry; 273 are open to participants now.
Of its 369 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
13 of the studies in Asthma by AstraZeneca that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05692180Phase 3AstraZenecaA Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma | 2026-12-23 |
| NCT06473779Phase 3AstraZenecaOpen-label Study to Assess Reduction of Background Asthma Medication While Sustaining Asthma Control and Clinical Remission With Tezepelumab in Patients 12-80yrs With Severe Asthma. | 2027-06-25 |
| NCT06471257Phase 3AstraZenecaA Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma | 2027-10-04 |
| NCT06307665Phase 3AstraZenecaEvaluating the Efficacy and Safety of PT027 Compared With PT007 Administered As Needed in Participants 12 to < 18 Years of Age With Asthma | 2027-10-13 |
| NCT07218172AstraZenecaCharacterization and Clinical Outcomes of Severe Asthma Patients in Israel Treated With Benralizumab (SAIL-B) | 2026-11-30 |
Add all 13 to your calendar (.ics) → With an account.
Among the 359 studies in Asthma by AstraZeneca, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
Inclusion Criteria:
Age
Participant must be aged 18 to 65 years (inclusive), at the time of signing the .
Type of Participant and Disease Characteristics
Must be receiving one of the following required inhaled asthma therapies listed below for at least the last 30 days:
Demonstrate acceptable MDI administration technique. Note: Use of a spacer device during the screening and randomized treatment periods is not permitted.
Weight
Female participants: A participant of , 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 , 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):
Progestogen-only hormonal contraception associated with inhibition of ovulation:
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
Exclusion Criteria:
5.2 Exclusion Criteria
Participants are excluded from the study if any of the following criteria apply:
Medical Conditions and History
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
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
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.
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.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
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).
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
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.
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.
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.
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.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
QT and QTc
On an ECG, the QT interval is the time the heart’s lower chambers take to activate electrically and recover in each beat. QTc is that time adjusted for heart rate (QTcF by Fridericia’s formula, QTcB by Bazett’s). Some medicines lengthen it, and a long QTc can raise the risk of a dangerous heart rhythm.
The study may name a correction formula and a limit in milliseconds, often around 450–480.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
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.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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.
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
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
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
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
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
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
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)
Drug: Treatment (Ventolin Evohaler) Randomized participants will receive a single-dose (2 inhalations)
Drug: Treatment (Placebo MDI) Randomized participants will receive a single-dose (2 inhalations to match AS MDI)
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)
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)
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.
| 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 |
| 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 |
| 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 |
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).
| 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) |
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).
| 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) |
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).
| 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) |
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).
| 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) |
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.
| 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) |
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.
| 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) |
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.
| 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) |
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).
| 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) |
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).
| 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) |
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.
| 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%) |
| 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 |
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(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(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)(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)(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(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(%) | 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 |
PDFs hosted by the registry, ClinicalTrials.gov.
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, Statistical analysis plan
Time frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Phrma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access criteria: When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.
Data sharing details ↗ · vivli.org
Ran from Feb 2025 to primary completion in Jun 2025, 3 months.
Results were first posted in Aug 2026, 1 year 2 months after primary completion.
Of 137 industry-sponsored phase 2 interventional studies under Asthma, half reached primary completion within 16 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 23. This study's 3 months is below that.
Counting every sponsor, half of 199 studies reached it within 20 months; a quarter within 12 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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