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NCT02980133 · ClinicalTrials.gov registry record · Phase 3
Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler
A Phase 3 study of Asthma, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 841
- Enrollment target
- 20
- Study locations
NCT02980133: Completed Phase 3 study of Asthma, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT02980133 is a Phase 3 study of Asthma that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 841 participants, below the 1,561-participant average among 374 other Asthma trials with a reported enrollment target (46% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02980133, a Phase 3 study of Asthma, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 841 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is to evaluate the safety and efficacy of fluticasone propionate and fluticasone propionate salmeterol in pediatric participants with a documented history of persistent asthma.
Primary Outcome
FEV1 was the volume of air exhaled in the first second of a forced expiration as measured by spirometer. The baseline 1-hour trough morning percent predicted FEV1 was defined as the predose trough morning percent predicted FEV1 measurement at the randomization visit (Baseline \[Day 1\]) at the investigational center. The IMP dose was administered right after the predose FEV1 measurement (within a 10 minute window). Participant then performed 1-hour (±10 minutes) postdose lung function assessment
Conditions Studied
Interventions
- DRUG Fluticasone Propionate
- DRUG Fluticasone Propionate/Salmeterol
- DRUG Placebo MDPI
Study Locations (20)
California
- Teva Investigational Site 13906 - Bakersfield
- Teva Investigational Site 14615 - Corona
- Teva Investigational Site 13892 - Downey
- Teva Investigational Site 13875 - Fountain Valley
- Teva Investigational Site 13904 - Huntington Beach
- Teva Investigational Site 13877 - Huntington Beach
- Teva Investigational Site 14668 - Long Beach
- Teva Investigational Site 13914 - Napa
- Teva Investigational Site 13918 - Paramount
- Teva Investigational Site 14618 - Rolling Hills Estates
- Teva Investigational Site 13912 - Roseville
- Teva Investigational Site 13847 - Stockton
- Teva Investigational Site 13848 - Thousand Oaks
Colorado
- Teva Investigational Site 13856 - Centennial
- Teva Investigational Site 13910 - Colorado Springs
- Teva Investigational Site 13868 - Longmont
Florida
- Teva Investigational Site 13913 - Chiefland
- Teva Investigational Site 14616 - DeLand
Alabama
- Teva Investigational Site 13881 - Birmingham
Arkansas
- Teva Investigational Site 13883 - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 841 participants |
| Start Date | 2016-12-28 |
| Est. Completion | 2019-04-13 |
| Phase | Phase 3 |
What the finished NCT02980133 record still lists
NCT02980133 is an interventional study that assigns participants to a tested intervention. The registered 841 participants enrollment target is mid-sized for trials with a published cap, below the 1,561-participant average among 374 other Asthma trials with a reported enrollment target (46% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 3 interventions - of which Fluticasone Propionate is the first listed.
NCT02980133 names 20 study sites across 5 states, led by California, Colorado, Florida.
Frequently Asked Questions
What is clinical trial NCT02980133 about?
NCT02980133 is a clinical study titled "Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler". This study is to evaluate the safety and efficacy of fluticasone propionate and fluticasone propionate salmeterol in pediatric participants with a documented history of persistent asthma.
What is the current status of trial NCT02980133?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 841 participants. The study started on 2016-12-28. Estimated completion is 2019-04-13.
What conditions does trial NCT02980133 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT02980133?
The interventions under investigation include: Fluticasone Propionate (DRUG), Fluticasone Propionate/Salmeterol (DRUG), Placebo MDPI (DRUG).
Who is sponsoring clinical trial NCT02980133?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02980133 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Asthma
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02980133's enrollment target sits among peer trials
841 52nd of 374 higher than 323 of 374 other Asthma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Asthma 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.
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