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NCT03364608 · ClinicalTrials.gov registry record · Phase 2
Study to Compare PT007 to Placebo MDI and Open-Label Proventil® HFA in Adult and Adolescent Subjects With Asthma
A Phase 2 study, sponsored by AstraZeneca.
- Completed
- Registry status
- Phase 2
- Development phase
- 86
- Enrollment target
NCT03364608: Completed Phase 2 study, sponsored by AstraZeneca.
NCT03364608 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 86 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03364608, a Phase 2 study, has completed, sponsored by AstraZeneca.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 86 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- OTHER Placebo MDI
- DRUG AS MDI 90 μg
- DRUG AS MDI 180 µg
- DRUG Proventil 90 μg
- DRUG Proventil 180 μg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 86 participants |
| Start Date | 2017-12-15 |
| Est. Completion | 2018-03-30 |
| Phase | Phase 2 |
What the finished NCT03364608 record still lists
NCT03364608 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 86 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (35% lower).
The record links to 0 conditions, and to 5 interventions - of which Placebo MDI is the first listed.
NCT03364608 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03364608 about?
NCT03364608 is a clinical study titled "Study to Compare PT007 to Placebo MDI and Open-Label Proventil® HFA in Adult and Adolescent Subjects With Asthma". 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, compa...
What is the current status of trial NCT03364608?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 86 participants. The study started on 2017-12-15. Estimated completion is 2018-03-30.
What interventions are being tested in trial NCT03364608?
The interventions under investigation include: Placebo MDI (OTHER), AS MDI 90 μg (DRUG), AS MDI 180 µg (DRUG), Proventil 90 μg (DRUG), Proventil 180 μg (DRUG).
Who is sponsoring clinical trial NCT03364608?
This trial is sponsored by AstraZeneca, which has 1,285 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03364608's enrollment target sits among peer trials
86 812th of 2000 higher than 1,181 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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