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NCT02139644 · ClinicalTrials.gov registry record · Phase 3
Study of Fluticasone Propionate MDPI Compared With Fluticasone/Salmeterol MDPI in Adolescent and Adult Patients With Persistent Asthma
A Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 3
- Development phase
- 787
- Enrollment target
NCT02139644: Completed Phase 3 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT02139644 is a Phase 3 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 787 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02139644, a Phase 3 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 787 participants
- Enrollment target
Study Summary
The primary objective of this study was to evaluate the efficacy of fluticasone propionate multidose dry powder inhaler (Fp MDPI) and fluticasone propionate/salmeterol xinafoate multidose dry powder inhaler (FS MDPI) when administered over 12 weeks in patients 12 years of age and older with persistent asthma. Study drug and placebo was supplied in Teva multidose dry powder inhaler (MDPI) devices and provided for participants to use at home. Participants performed spirometry at every visit. Each participant was given a diary at each visit for use until the next visit. Rescue medication (albuterol/salbutamol) was dispensed at each visit, if needed, as determined by the investigational center personnel.
Primary Outcome
A subset of approximately 300 patients who performed postdose serial spirometry is based on sample size calculation. Data from these assessments were used to analyze the primary endpoint of baseline adjusted FEV1 AUEC0-12h at week 12 using the trapezoidal rule based on actual time of measurement. It was standardized by dividing it by the number of hours between the start time of dose administration and the end time of the last nonmissing FEV1 measurement. The baseline FEV1 was the average of th
Interventions
- DRUG Placebo MDPI
- DRUG Beclomethasone dipropionate
- DRUG Fp MDPI
- DRUG FS MDPI
- DRUG albuterol/salbutamol
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 787 participants |
| Start Date | 2014-06 |
| Est. Completion | 2015-09 |
| Phase | Phase 3 |
What the finished NCT02139644 record still lists
NCT02139644 is an interventional study that assigns participants to a tested intervention. The registered 787 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 5 interventions - of which Placebo MDPI is the first listed.
NCT02139644 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02139644 about?
NCT02139644 is a clinical study titled "Study of Fluticasone Propionate MDPI Compared With Fluticasone/Salmeterol MDPI in Adolescent and Adult Patients With Persistent Asthma". The primary objective of this study was to evaluate the efficacy of fluticasone propionate multidose dry powder inhaler (Fp MDPI) and fluticasone propionate/salmeterol xinafoate multidose dry powder inhaler (FS MDPI) when administered over 12 weeks in patients 12 years of age and older with persiste...
What is the current status of trial NCT02139644?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 787 participants. The study started on 2014-06. Estimated completion is 2015-09.
What interventions are being tested in trial NCT02139644?
The interventions under investigation include: Placebo MDPI (DRUG), Beclomethasone dipropionate (DRUG), Fp MDPI (DRUG), FS MDPI (DRUG), albuterol/salbutamol (DRUG).
Who is sponsoring clinical trial NCT02139644?
This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02139644's enrollment target sits among peer trials
787 431st of 2000 higher than 1,570 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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