A Phase 2 interventional study of AS MDI and Proventil in Asthma, sponsored by AstraZeneca. Completed at 5 sites in United States. Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2019-07-23.
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 185th largest by enrollment of the 248 interventional ones that give a count, is one of 13 that started in 2017, is one of 50 in phase 2, and was the 231st registered.
4,846 studies on the registry are indexed under Asthma; 602 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; 146 take children under 18; 104 take healthy volunteers.
This study: 18 Years to 45 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 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 46 is below the median of 79 across 3,342 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.
This is a randomized, cumulative dose, open-label, 2-period crossover, multi-center study to assess the safety, efficacy, PK, and extrapulmonary PD of cumulative doses of AS MDI compared to cumulative doses of Proventil as an active control in subjects with mild to moderate asthma
This is a randomized, cumulative dose, open-label, 2-period crossover, multi-center study to assess the safety, efficacy, PK, and extrapulmonary pharmacodynamics (PD) of cumulative doses of Albuterol Sulfate Pressurized Inhalation Suspension (hereafter referred to as AS MDI) compared to cumulative doses of Proventil® hydrofluoroalkane (HFA; hereafter referred to as Proventil) as an active control in subjects with mild to moderate asthma.
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.
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.
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.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
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.
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.
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.
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.
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.
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.
AS MDI 1+1+2+4+8 inhalations of 90 μg per inhalation
Drug: AS MDI
Proventil 1+1+2+4+8 inhalations of 90 μg per inhalation
Drug: Proventil
AS MDI 1+1+2+4+8 inhalations of 90 μg per inhalation
Proventil 1+1+2+4+8 inhalations of 90 μg per inhalation
Baseline-adjusted FEV1 30 Minutes After Each Cumulative Dose
Forced expiratory volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation
Time frame: At the two study treatment visits, FEV1 (forced expiratory volume in 1 second) will be measured prior to drug administration and 5 times, once at 30 minutes after each of the 5 doses
Baseline-adjusted FEV1 AUC0-6 After the Last Cumulative Dose
The baseline-adjusted FEV1 AUC0-6 is the area under the curve for change from baseline calculated using the trapezoidal rule and normalized by dividing the AUC by the length of follow up post the last cumulative dose (typically 6 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose) normalized for length of follow up).
Time frame: Over 6 hours post dose on Day 1
| Milestone | Treatment Sequence A | Treatment Sequence B |
|---|---|---|
| Started | 23 | 23 |
| Completed | 23 | 23 |
| Not completed | 0 | 0 |
| Milestone | Treatment Sequence A | Treatment Sequence B |
|---|---|---|
| Started | 23 | 23 |
| Completed | 23 | 22 |
| Not completed | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
| Milestone | Treatment Sequence A | Treatment Sequence B |
|---|---|---|
| Started | 23 | 22 |
| Completed | 23 | 22 |
| Not completed | 0 | 0 |
Forced expiratory volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation
| Liter | AS MDI | Proventil |
|---|---|---|
| Dose 1 - 90 μg | 0.421 (0.300 to 0.543) | 0.488 (0.367 to 0.610) |
| Cumulative Dose - 180 μg | 0.548 (0.432 to 0.665) | 0.586 (0.469 to 0.702) |
| Cumulative Dose - 360 μg | 0.619 (0.502 to 0.737) | 0.647 (0.529 to 0.765) |
| Cumulative Dose - 720 μg | 0.659 (0.544 to 0.775) | 0.690 (0.575 to 0.805) |
| Cumulative Dose - 1440 μg | 0.721 (0.602 to 0.840) | 0.805 (0.686 to 0.925) |
The baseline-adjusted FEV1 AUC0-6 is the area under the curve for change from baseline calculated using the trapezoidal rule and normalized by dividing the AUC by the length of follow up post the last cumulative dose (typically 6 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose) normalized for length of follow up).
| Liter | AS MDI | Proventil |
|---|---|---|
| Baseline-adjusted FEV1 AUC0-6 After the Last Cumulative Dose | 0.561 (0.448 to 0.674) | 0.602 (0.489 to 0.715) |
Collected over Adverse events were collected from the time the subject signed informed consent throughout the treatment period and up to 14 days following the last dose of study drug. Non-serious events are listed at a 2% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AS MDI | 0/45 (0%) | 0/45 (0%) | 8/45 (17.8%) |
| Proventil | 0/46 (0%) | 0/46 (0%) | 10/46 (21.7%) |
| Event | AS MDI | Proventil |
|---|---|---|
| Feeling JitteryGeneral disorders | 3/45 | 6/46 |
| TremorNervous system disorders | 2/45 | 2/46 |
| HeadacheNervous system disorders | 2/45 | 0/46 |
| DizzinessNervous system disorders | 1/45 | 0/46 |
| VomitingGastrointestinal disorders | 1/45 | 0/46 |
| Blood Potassium decreasedInvestigations | 0/45 | 1/46 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 0/45 | 1/46 |
| Age, Continuous(Years) | mITT Population |
|---|---|
| Least squares mean | 34.2 ± 7.4 |
| Sex: Female, Male(Participants) | mITT Population |
|---|---|
| Female | 22 |
| Male | 23 |
| Ethnicity (NIH/OMB)(Participants) | mITT Population |
|---|---|
| Hispanic or Latino | 7 |
| Not Hispanic or Latino | 38 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | mITT Population |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 11 |
| White | 34 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2017 to primary completion in Mar 2018, 2 months.
Results were first posted in Jul 2019, 1 year 3 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 2 months is below that.
Counting every sponsor, half of 198 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 Jun 2019. You cannot join it, but the record below documents what was studied.
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