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NCT01772368 · ClinicalTrials.gov registry record · Phase 2
Dose Ranging Study of the Salmeterol Component of Fluticasone /Salmeterol Spiromax Compared to Fluticasone Spiromax and Advair Diskus in Asthma Subjects
A Phase 2 study of Asthma, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 2
- Development phase
- 72
- Enrollment target
- 10
- Study locations
NCT01772368: Completed Phase 2 study of Asthma, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT01772368 is a Phase 2 study of Asthma that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 72 participants, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (95% lower). The trial reports 10 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01772368, a Phase 2 study of Asthma, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 72 participants
- Enrollment target
- 10
- Study locations
Study Summary
The primary objective of this study is to evaluate the dose response, efficacy, and safety of 4 different doses of salmeterol Spiromax (6.25, 12.5, 25, and 50 mcg) each combined with a fixed dose of fluticasone propionate (100 mcg) delivered as Fluticasone/Salmeterol Spiromax® Inhalation Powder (FS Spiromax) when administered as a single dose in subjects 12 years of age and older with persistent asthma.
Primary Outcome
Standardized baseline-adjusted FEV1 AUC0-12 was defined as the area under the curve for baseline-adjusted FEV1 measurements from the predose to 12 hours postdose time points using the trapezoidal rule based on actual (not scheduled) time of measurement and was standardized by dividing the actual time of last non-missing FEV1 measurement. Baseline-adjusted FEV1 was calculated as postdose FEV1 after subtracting period-specific baseline FEV1. The period-specific baseline FEV1 was measured at predos
Conditions Studied
Interventions
- DRUG Albuterol
- DRUG Fp MDPI
- DRUG FS MDPI
- DRUG Advair Diskus
Study Locations (10)
Texas
- Teva Investigational Site 10457 - El Paso
- Teva Investigational Site 10450 - New Braunfels
- Teva Investigational Site 10456 - San Antonio
Oregon
- Teva Investigational Site 10451 - Medford
- Teva Investigational Site 10449 - Portland
Colorado
- Teva Investigational Site 10453 - Denver
Massachusetts
- Teva Investigational Site 10452 - North Dartmouth
Missouri
- Teva Investigational Site 10455 - St Louis
New Jersey
- Teva Investigational Site 10454 - Skillman
North Carolina
- Teva Investigational Site 10448 - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 72 participants |
| Start Date | 2013-01 |
| Est. Completion | 2013-06 |
| Phase | Phase 2 |
What the finished NCT01772368 record still lists
NCT01772368 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 72 participants, a relatively small participant target, below the 1,563-participant average among 374 other Asthma trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Asthma appearing as the primary indexed condition, and to 4 interventions - of which Albuterol is the first listed.
NCT01772368 lists 10 locations in 7 states (Texas, Oregon, Colorado).
Frequently Asked Questions
What is clinical trial NCT01772368 about?
NCT01772368 is a clinical study titled "Dose Ranging Study of the Salmeterol Component of Fluticasone /Salmeterol Spiromax Compared to Fluticasone Spiromax and Advair Diskus in Asthma Subjects". The primary objective of this study is to evaluate the dose response, efficacy, and safety of 4 different doses of salmeterol Spiromax (6.25, 12.5, 25, and 50 mcg) each combined with a fixed dose of fluticasone propionate (100 mcg) delivered as Fluticasone/Salmeterol Spiromax® Inhalation Powder (FS ...
What is the current status of trial NCT01772368?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 72 participants. The study started on 2013-01. Estimated completion is 2013-06.
What conditions does trial NCT01772368 study?
This clinical trial studies the following conditions: Asthma.
What interventions are being tested in trial NCT01772368?
The interventions under investigation include: Albuterol (DRUG), Fp MDPI (DRUG), FS MDPI (DRUG), Advair Diskus (DRUG).
Who is sponsoring clinical trial NCT01772368?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01772368 being conducted?
This trial has 10 study locations across Colorado, Massachusetts, Missouri, New Jersey, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01772368's enrollment target sits among peer trials
72 237th of 374 higher than 136 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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