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NCT01576718 · ClinicalTrials.gov registry record · Phase 2
A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler (Puffer) in Adolescents and Adults Who Have Asthma That is Not Controlled by High Dose Inhaled Corticosteroid Asthma Medications
A Phase 2 study, sponsored by Teva Branded Pharmaceutical Products R&D.
- Completed
- Registry status
- Phase 2
- Development phase
- 889
- Enrollment target
NCT01576718: Completed Phase 2 study, sponsored by Teva Branded Pharmaceutical Products R&D.
NCT01576718 is a Phase 2 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 889 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (568% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01576718, a Phase 2 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 889 participants
- Enrollment target
Study Summary
The primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate (50, 100, 200, and 400mcg) delivered as Fluticasone Spiromax® Inhalation Powder (Fp Spiromax) when administered twice daily in subjects 12 years of age and older with severe persistent asthma who are uncontrolled on high dose ICS therapy.
Primary Outcome
Trough FEV1 was measured electronically by spirometry at morning (AM) investigational site visits, before administration of the AM dose of study drug, and before albuterol/salbutamol administration. The highest FEV1 value from 3 acceptable and 2 reproducible maneuvers was used. All FEV1 data were submitted to a central reading center for evaluation. The p-values for the treatment comparisons to placebo are from an MMRM model excluding FLOVENT DISKUS data: change from baseline = baseline FEV1 +
Interventions
- DRUG Fp MDPI
- DRUG albuterol/salbutamol
- DRUG Flovent Diskus
- OTHER Placebo MDPI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 889 participants |
| Start Date | 2012-04 |
| Est. Completion | 2013-10 |
| Phase | Phase 2 |
What the finished NCT01576718 record still lists
NCT01576718 is an interventional study that assigns participants to a tested intervention. The registered 889 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (568% higher).
The record links to 0 conditions, and to 4 interventions - of which Fp MDPI is the first listed.
NCT01576718 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01576718 about?
NCT01576718 is a clinical study titled "A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler (Puffer) in Adolescents and Adults Who Have Asthma That is Not Controlled by High Dose Inhaled Corticosteroid Asthma Medications". The primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate (50, 100, 200, and 400mcg) delivered as Fluticasone Spiromax® Inhalation Powder (Fp Spiromax) when administered twice daily in subjects 12 years of age and older w...
What is the current status of trial NCT01576718?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 889 participants. The study started on 2012-04. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01576718?
The interventions under investigation include: Fp MDPI (DRUG), albuterol/salbutamol (DRUG), Flovent Diskus (DRUG), Placebo MDPI (OTHER).
Who is sponsoring clinical trial NCT01576718?
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 NCT01576718's enrollment target sits among peer trials
889 33rd of 2000 higher than 1,968 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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