A Phase 3 interventional study of Budesonide/albuterol metered-dose inhaler 160/180 μg and Placebo metered-dose inhaler in Asthma, Exercise-Induced, sponsored by AstraZeneca. Completed at 6 sites in Russia. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-08-27.
Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment
The purpose of this Phase III, multicentre, randomized, double-blind, single-dose, 2-period, crossover study is to assess the efficacy and safety of PT027 (budesonide/albuterol sulfate) metered-dose inhaler compared with placebo on exercise-induced bronchoconstriction in adult patients with asthma. Subjects will receive each study treatment on separate visits and undergo a treadmill exercise challenge test so that the effect of study treatment on exercise-induced bronchoconstriction can be evaluated
52 studies on the registry are indexed under Asthma, Exercise-Induced; 3 are open to participants now.
This study's enrollment of 64 is above the median of 47 across 40 interventional studies indexed under Asthma, Exercise-Induced.
Browse Asthma, Exercise-Induced studies →AstraZeneca is the lead sponsor of 3,499 studies on the registry; 270 are open to participants now.
Of its 368 completed or terminated interventional studies of FDA-regulated products, 178 (48%) have results posted.
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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.
Receiving 1 of the following asthma therapies with stable dosing for at least the 4 weeks before Visit 1 (no other asthma therapies are permitted during the study):
Exclusion Criteria:
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.
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
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.
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.
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.
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.
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.
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.
Subjects randomized to receive a single dose of PT027 160/180 μg in treatment Period 1, and a single dose of Placebo in treatment Period 2.
Drug: Budesonide/albuterol metered-dose inhaler 160/180 μg · Drug: Placebo metered-dose inhaler
Subjects randomized to receive a single dose of Placebo in treatment Period 1, and a single dose of PT027 160/180 in treatment Period 2.
Drug: Budesonide/albuterol metered-dose inhaler 160/180 μg · Drug: Placebo metered-dose inhaler
Budesonide/albuterol combination aerosol for inhalation, single dose (given as 2 actuations of 80/90 μg)
Also known as: PT027 (BDA MDI) 160/180 μg
Placebo aerosol for inhalation, single dose (given as 2 actuations)
Also known as: Placebo MDI
Maximum Percentage Fall From Post-dose, Pre-exercise Baseline in Forced Expiratory Volume in 1 Second (FEV₁) Observed up to 60 Minutes Post-exercise Challenge
Lung function was measured by spirometry. Spirometry assessments were completed 5 minutes before dosing, 30 minutes after dosing (baseline; 5 minutes before the exercise challenge), and then 5, 10, 15, 30, and 60 minutes after the exercise challenge. A reduction in FEV₁ was expected due to the effects of asthma and exercise on breathing and lung function. The percentage fall in FEV₁ was calculated based on the baseline value and maximum percentage fall value during the 60-minute assessment period.
Time frame: Up to 60 minutes post-exercise challenge
Percentage of Subjects With a Maximum Percentage Fall in FEV₁ Post-exercise Challenge of <10% and <20%
The percentage fall in FEV₁ was calculated based on the baseline value and maximum percentage fall value during the 60-minute assessment period, and the percentage of subjects with a maximum percentage fall \<10% and \<20% was determined
Time frame: Up to 60 minutes post exercise challenge
Percentage Fall From Post-dose, Pre-exercise Baseline in FEV1 at Each Time Point Within 60 Minutes Post-exercise Challenge
The percentage fall in FEV₁ at each time point was calculated based on the baseline value and percentage fall value during the 60-minute assessment period at each time point.
Time frame: Up to 60 minutes post exercise challenge
Post-Exercise FEV1 Area Under the Curve From 0 to 30 Minutes (AUC0-30min)
FEV1 AUC0-30min will be derived for the changes from the post-dose, pre-exercise baseline using the trapezoidal rule and will be normalized by dividing by the actual time (in minutes) from dosing to the last included measurement, scheduled at 30 minutes post-exercise challenge.
Time frame: Up to 30 minutes post exercise challenge
Time To Recovery
Time to recovery will be derived as the time (minutes) post-exercise challenge in which the FEV1 result returns to within 10% of the value recorded at the post-dose, pre-exercise baseline.
Time frame: Up to 60 minutes post exercise challenge
Number of Participants With Adverse Events (AEs)
The safety profile will be evaluated using vital signs, physical examination, electrocardiograms (ECGs) and AE data.
Time frame: Through study completion, an average of 4 weeks
| Milestone | Budesonide/Albuterol Metered-dose Inhaler (BDA MDI) 160/180 - Placebo | Placebo - Budesonide/Albuterol Metered-dose Inhaler (BDA MDI) 160/180 |
|---|---|---|
| Started | 31 | 33 |
| Completed | 31 | 33 |
| Not completed | 0 | 0 |
| Milestone | Budesonide/Albuterol Metered-dose Inhaler (BDA MDI) 160/180 - Placebo | Placebo - Budesonide/Albuterol Metered-dose Inhaler (BDA MDI) 160/180 |
|---|---|---|
| Started | 31 | 33 |
| Completed | 31 | 33 |
| Not completed | 0 | 0 |
| Milestone | Budesonide/Albuterol Metered-dose Inhaler (BDA MDI) 160/180 - Placebo | Placebo - Budesonide/Albuterol Metered-dose Inhaler (BDA MDI) 160/180 |
|---|---|---|
| Started | 31 | 33 |
| Completed | 31 | 33 |
| Not completed | 0 | 0 |
Lung function was measured by spirometry. Spirometry assessments were completed 5 minutes before dosing, 30 minutes after dosing (baseline; 5 minutes before the exercise challenge), and then 5, 10, 15, 30, and 60 minutes after the exercise challenge. A reduction in FEV₁ was expected due to the effects of asthma and exercise on breathing and lung function. The percentage fall in FEV₁ was calculated based on the baseline value and maximum percentage fall value during the 60-minute assessment period.
| Percent fall | BDA MDI 160/180 | Placebo |
|---|---|---|
| All subjects | 6.95 (5.36 to 8.54) | 24.46 (22.87 to 26.05) |
| Non-ICS | 6.28 (3.63 to 8.93) | 26.62 (23.97 to 29.28) |
| ICS | 7.29 (5.32 to 9.25) | 23.28 (21.32 to 25.25) |
The percentage fall in FEV₁ was calculated based on the baseline value and maximum percentage fall value during the 60-minute assessment period, and the percentage of subjects with a maximum percentage fall \<10% and \<20% was determined
| Participants | BDA MDI 160/180 | Placebo |
|---|---|---|
| Maximum percentage fall <10% | 48 | 2 |
| Maximum percentage fall <20% | 62 | 14 |
The percentage fall in FEV₁ at each time point was calculated based on the baseline value and percentage fall value during the 60-minute assessment period at each time point.
| Percent | BDA MDI 160/180 | Placebo |
|---|---|---|
| 5 min Post-ECT | 1.68 (-0.11 to 3.47) | 9.79 (8.00 to 11.58) |
| 10 min Post-ECT | 3.16 (1.30 to 5.02) | 17.98 (16.12 to 19.84) |
| 15 min Post-ECT | 4.20 (2.38 to 6.03) | 19.14 (17.31 to 20.97) |
| 30 min Post-ECT | 2.64 (0.65 to 4.63) | 11.85 (9.87 to 13.84) |
| 60 min Post-ECT | 0.56 (-0.83 to 1.94) | 3.10 (1.72 to 4.48) |
FEV1 AUC0-30min will be derived for the changes from the post-dose, pre-exercise baseline using the trapezoidal rule and will be normalized by dividing by the actual time (in minutes) from dosing to the last included measurement, scheduled at 30 minutes post-exercise challenge.
| liter | BDA MDI 160/180 | Placebo |
|---|---|---|
| Post-Exercise FEV1 Area Under the Curve From 0 to 30 Minutes (AUC0-30min) | -0.10 ± 0.16 | -0.44 ± 0.23 |
Time to recovery will be derived as the time (minutes) post-exercise challenge in which the FEV1 result returns to within 10% of the value recorded at the post-dose, pre-exercise baseline.
| Participants | BDA MDI 160/180 | Placebo |
|---|---|---|
| Time To Recovery | 56 | 6 |
The safety profile will be evaluated using vital signs, physical examination, electrocardiograms (ECGs) and AE data.
| Participants | BDA MDI 160/180 | Placebo |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | 1 | 2 |
Collected over Adverse events presented in the tables below were collected during up to 19 days from the time of first study treatment to follow-up telephone call. Actual time for each participant depends on duration of their participation in the study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| BDA MDI 160/180 | 0/64 (0%) | 0/64 (0%) | 1/64 (1.6%) |
| Placebo | 0/64 (0%) | 0/64 (0%) | 2/64 (3.1%) |
| Event | BDA MDI 160/180 | Placebo |
|---|---|---|
| DiarrhoeaGastrointestinal disorders | 0/64 | 1/64 |
| HeadacheNervous system disorders | 0/64 | 1/64 |
| Bronchial irritationRespiratory, thoracic and mediastinal disorders | 1/64 | 0/64 |
| Age, Continuous(years) | Budesonide/Albuterol Metered-dose Inhaler (BDA MDI) 160/180 - Placebo | Placebo - Budesonide/Albuterol Metered-dose Inhaler (BDA MDI) 160/180 | Total |
|---|---|---|---|
| Mean | 39.0 ± 14.5 | 43.2 ± 13.9 | 41.1 ± 14.2 |
| Age, Customized(Participants) | Budesonide/Albuterol Metered-dose Inhaler (BDA MDI) 160/180 - Placebo | Placebo - Budesonide/Albuterol Metered-dose Inhaler (BDA MDI) 160/180 | Total |
|---|---|---|---|
| < 65 years | 30 | 32 | 62 |
| >= 65 years | 1 | 1 | 2 |
| Sex: Female, Male(Participants) | Budesonide/Albuterol Metered-dose Inhaler (BDA MDI) 160/180 - Placebo | Placebo - Budesonide/Albuterol Metered-dose Inhaler (BDA MDI) 160/180 | Total |
|---|---|---|---|
| Female | 19 | 17 | 36 |
| Male | 12 | 16 | 28 |
| Race/Ethnicity, Customized(Participants) | Budesonide/Albuterol Metered-dose Inhaler (BDA MDI) 160/180 - Placebo | Placebo - Budesonide/Albuterol Metered-dose Inhaler (BDA MDI) 160/180 | Total |
|---|---|---|---|
| White | 31 | 33 | 64 |
| Race/Ethnicity, Customized(Participants) | Budesonide/Albuterol Metered-dose Inhaler (BDA MDI) 160/180 - Placebo | Placebo - Budesonide/Albuterol Metered-dose Inhaler (BDA MDI) 160/180 | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 31 | 32 | 63 |
| Not Reported | 0 | 1 | 1 |
| Pre-dose pre-exercise challenge test (ECT) forced expiratory volume in 1 second (FEV1)(liters) | Budesonide/Albuterol Metered-dose Inhaler (BDA MDI) 160/180 - Placebo | Placebo - Budesonide/Albuterol Metered-dose Inhaler (BDA MDI) 160/180 | Total |
|---|---|---|---|
| Mean | 2.925 ± 0.826 | 3.042 ± 0.877 | 2.985 ± 0.848 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2023 to primary completion in Jun 2024, 6 months.
Results were first posted in Aug 2025, 1 year 1 month after primary completion.
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