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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 is a Phase 2 study that has completed, run by AstraZeneca. The registered enrollment target is 86 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03364608
The ClinicalTrials.gov registry entry for NCT03364608 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 86 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is AstraZeneca, which has 1,285 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Placebo MDI is the first listed.
NCT03364608 reports 0 study locations.
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.
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