A Phase 2 interventional study of AS MDI 90 μg and AS MDI 180 µg in Asthma, sponsored by AstraZeneca. Completed at 10 sites in United States. Open to participants aged 12 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-07-24.
Sponsored by AstraZeneca · Phase 2, Interventional, and Treatment
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Among 72 studies testing albuterol in Asthma — 8 open to participants now, 9 under way, 1 of them phase 3. Albuterol · Asthma.
Among the 72 studies testing albuterol in Asthma, this one is the 29th largest by enrollment, is one of 5 that started in 2017, is one of 8 in phase 2, and was the 48th registered.
4,843 studies on the registry are indexed under Asthma; 602 are open to participants now.
Browse Asthma studies →8 of the 72 studies testing albuterol in Asthma are open now, in 6 countries. Recruiting first, the newest first:
University of Miami · Sites in United States
Ages 18–75
Massachusetts General Hospital · Sites in United States
Ages 18–54
University of British Columbia · Sites in Canada
Ages 18–55 · Healthy volunteers
GlaxoSmithKline · Sites in United Kingdom
Ages 18–65
Hat Yai Medical Education Center · Sites in Thailand
Ages 18–60
By country, each count listing its studies:
Albuterol: first FDA approval 1981 (PROVENTIL). What it is approved for, and how studies give it, is on its page →
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: 12 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.
72 studies; the count open now beside each. This study's row is marked.
First in 1993; this study’s year is marked. 5 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 86 is close to the median of 79 across 3,342 interventional studies indexed under Asthma.
Median enrollment 63 across the 72 interventional studies. Of the 53 that completed or were terminated, 27 (51%) have results posted.
This tab as a report to print or save as PDF → With an account.
36 of 72 have an industry lead sponsor. The 10 most frequent:
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.
359 studies in Asthma by AstraZeneca: 19 open now, 28 under way, 8 of them phase 3. Of 330 finished, 129 (39%) have results posted.
Among the 359 studies in Asthma by AstraZeneca, this one is the 160th 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.
AstraZeneca’s Asthma studies by the year they started, since 1996.
2 of the studies testing albuterol in Asthma that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06433921GlaxoSmithKlineA Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive | 2027-04-16 |
| NCT07166939Massachusetts General Hospital45th Multicenter Airway Research Collaboration | 2027-06 |
Add all 2 to your calendar (.ics) → With an account.
Among the 72 studies testing albuterol in Asthma, from their registry updates:
Among AstraZeneca’s 359 in Asthma:
This tab as a report to print or save as PDF → With an account.
This is a randomized, double-blind, single-dose, placebo-controlled, 5-period, 5-treatment, crossover, multi-center study to assess the bronchodilatory effect and safety of 2 dose levels of Albuterol Sulfate Pressurized Inhalation Suspension (hereafter referred to as AS MDI), 90 μg and 180 μg, compared with placebo for AS MDI (hereafter referred to as Placebo MDI) and open-label Proventil® hydrofluoroalkane (HFA; hereafter referred to as Proventil) 90 μg and 180 μg in adult and adolescent subjects with mild to moderate asthma. This study design utilizes 10 treatment sequences.
This is a 5-period crossover study. Each Treatment Period is 1 day. Subjects will receive a single dose of randomized study drug at each of the 5 Treatment Visits (Visits 2, 3, 4, 5, and 6), with a 3- to 7-day Washout Period between Treatment Visits.
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.
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.
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.
(2 actuations of 45 µg/actuation)
Drug: AS MDI 90 μg
(2 actuations of 90 µg/actuation)
Drug: AS MDI 180 µg
(2 actuations)
Other: Placebo MDI
(1 actuation of 90 µg/actuation)
Drug: Proventil 90 μg
(2 actuations of 90 µg/actuation)
Drug: Proventil 180 μg
AS MDI 90 μg (2 actuations of 45 μg/actuation)
Also known as: AS MDI
AS MDI 180 μg (2 actuations of 90 μg/actuation)
Also known as: AS MDI
Placebo MDI (2 actuations)
Proventil 90 μg (1 actuation of 90 μg/actuation)
Also known as: Proventil
Proventil 180 μg (2 actuations of 90 μg/actuation)
Also known as: Proventil
Change From Baseline in FEV1 AUC0-6
Change from baseline in FEV1 (Forced expiratory volume in 1 second) AUC0-6 (Area under the curve from 0 to 6 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose) normalized for length of follow up.
Time frame: Over 6 hours post dose on Day 1
Change From Baseline in FEV1 AUC0-4
Change from baseline in FEV1 (Forced expiratory volume in 1 second) AUC0-4 (Area under the curve from 0 to 4 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 4 hours post dose on Day 1
Peak Change From Baseline in FEV1
Peak Change from baseline in FEV1 (Forced expiratory volume in 1 second)
Time frame: Over 6 hours post dose on Day 1
This study was conducted at 10 sites in the United States, from December 2017 to March 2018. The study was anticipated to run for at least 23 days but not to exceed 68 days.
| Milestone | Subjects |
|---|---|
| Started | 86 |
| Placebo mdi | 82 |
| As mdi 90 µg | 81 |
| As mdi 180 µg | 81 |
| Proventil 90 µg | 82 |
| Proventil 180 µg | 79 |
| Completed | 78 |
| Not completed | 8 |
| Withdrew: Withdrawal by subject | 4 |
| Withdrew: Protocol violation | 2 |
| Withdrew: Lost to follow-up | 2 |
Change from baseline in FEV1 (Forced expiratory volume in 1 second) AUC0-6 (Area under the curve from 0 to 6 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, 240, 300, and 360 minutes post-dose) normalized for length of follow up.
| Liters | AS MDI 180 µg | AS MDI 90 µg | Proventil 180 µg | Proventil 90 µg | Placebo MDI |
|---|---|---|---|---|---|
| Change From Baseline in FEV1 AUC0-6 | 0.266 (0.219 to 0.313) | 0.203 (0.156 to 0.251) | 0.282 (0.234 to 0.329) | 0.240 (0.193 to 0.288) | 0.070 (0.022 to 0.117) |
Change from baseline in FEV1 (Forced expiratory volume in 1 second) AUC0-4 (Area under the curve from 0 to 4 hours) (spirometry will be obtained at 5, 15, 30, 45, 60, 120, 180, and 240 minutes post-dose) normalized for length of follow up.
| Liters | AS MDI 180 µg | AS MDI 90 µg | Proventil 180 µg | Proventil 90 µg | Placebo MDI |
|---|---|---|---|---|---|
| Change From Baseline in FEV1 AUC0-4 | 0.331 (0.280 to 0.381) | 0.263 (0.213 to 0.313) | 0.349 (0.299 to 0.400) | 0.297 (0.247 to 0.348) | 0.080 (0.030 to 0.131) |
Peak Change from baseline in FEV1 (Forced expiratory volume in 1 second)
| Liters | AS MDI 180 µg | AS MDI 90 µg | Proventil 180 µg | Proventil 90 µg | Placebo MDI |
|---|---|---|---|---|---|
| Peak Change From Baseline in FEV1 | 0.509 (0.451 to 0.567) | 0.433 (0.375 to 0.491) | 0.516 (0.458 to 0.574) | 0.472 (0.414 to 0.530) | 0.233 (0.176 to 0.291) |
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 |
|---|---|---|---|
| Placebo MDI | 0/82 (0%) | 0/82 (0%) | 0/82 (0%) |
| AS MDI 90 µg | 0/81 (0%) | 0/81 (0%) | 0/81 (0%) |
| Proventil 180 µg | 0/81 (0%) | 0/81 (0%) | 0/81 (0%) |
| Proventil 90 µg | 0/82 (0%) | 0/82 (0%) | 0/82 (0%) |
| • Proventil 180 µg | 0/79 (0%) | 0/79 (0%) | 0/79 (0%) |
Overall number of Baseline Participants is from the Safety set.
| Age, Continuous(Years) | Overall Study |
|---|---|
| Mean | 42.7 ± 13.4 |
| Sex: Female, Male(Participants) | Overall Study |
|---|---|
| Female | 47 |
| Male | 39 |
| Ethnicity (NIH/OMB)(Participants) | Overall Study |
|---|---|
| Hispanic or Latino | 14 |
| Not Hispanic or Latino | 72 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Overall Study |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 20 |
| White | 62 |
| More than one race | 0 |
| Unknown or Not Reported | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Ran from Dec 2017 to primary completion in Mar 2018, 3 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 3 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 Jul 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Albuterol