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NCT01479621 · 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 in Adolescents and Adults Who Have Asthma That is Not Controlled by Asthma Medications Not Containing Steroids

A Phase 2 study, sponsored by Teva Branded Pharmaceutical Products R&D.

Completed
Registry status
Phase 2
Development phase
909
Enrollment target

NCT01479621: Completed Phase 2 study, sponsored by Teva Branded Pharmaceutical Products R&D.

NCT01479621 is a Phase 2 study that has completed, run by Teva Branded Pharmaceutical Products R&D. The registered enrollment target is 909 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (583% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01479621, a Phase 2 study, has completed, sponsored by Teva Branded Pharmaceutical Products R&D.

COMPLETED
Registry status
Phase 2
Development phase
909 participants
Enrollment target

Study Summary

This is a randomized, double-blind, placebo- and open-label active controlled, parallel-group, multicenter, dose ranging study in male or female subjects ages 12 years and older with persistent asthma who are uncontrolled on non-steroidal therapy. The primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate delivered as Fluticasone Propionate DPI (Dry Powder Inhaler) when administered twice daily.

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 + s

Interventions

  • DRUG Placebo MDPI
  • DRUG Fp MDPI
  • DRUG albuterol/salbutamol
  • DRUG Flovent Diskus

Trial Details

FieldValue
Enrollment Target 909 participants
Start Date 2012-01
Est. Completion 2013-07
Phase Phase 2

What the finished NCT01479621 record still lists

NCT01479621 is an interventional study that assigns participants to a tested intervention. The registered 909 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 (583% higher).

The record links to 0 conditions, and to 4 interventions - of which Placebo MDPI is the first listed.

NCT01479621 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01479621 about?

NCT01479621 is a clinical study titled "A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler in Adolescents and Adults Who Have Asthma That is Not Controlled by Asthma Medications Not Containing Steroids". This is a randomized, double-blind, placebo- and open-label active controlled, parallel-group, multicenter, dose ranging study in male or female subjects ages 12 years and older with persistent asthma who are uncontrolled on non-steroidal therapy. The primary objective of this study is to evaluate t...

What is the current status of trial NCT01479621?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 909 participants. The study started on 2012-01. Estimated completion is 2013-07.

What interventions are being tested in trial NCT01479621?

The interventions under investigation include: Placebo MDPI (DRUG), Fp MDPI (DRUG), albuterol/salbutamol (DRUG), Flovent Diskus (DRUG).

Who is sponsoring clinical trial NCT01479621?

This trial is sponsored by Teva Branded Pharmaceutical Products R&D, which has 167 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01479621's enrollment target sits among peer trials

909 30th of 2000 higher than 1,971 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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Source: ClinicalTrials.gov NCT01479621, the US trial registry maintained by the National Library of Medicine. NCT01479621 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.