Completed PHASE3 INTERVENTIONAL 4-arm NCT00393991

Comparison of New Combination Inhaler (FlutiForm HFA MDI 100/10 µg) Versus Fluticasone and Formoterol Administered Alone, and Placebo, in Patients With Asthma

A Randomized, Double-blind, Placebo-controlled, Parallel, Stratified, Multi-center, 12-Week Study Comparing the Safety & Efficacy of Fluticasone and Formoterol Combination (FlutiForm(tm)100/10 µg Twice Daily) in a Single Inhaler (SkyePharma HFA pMDI)With the Administration of Placebo or Fluticasone (100 µg Twice Daily) and Formoterol (10 µg Twice Daily) Alone in Adolescent and Adult Patients With Mild to Moderate Asthma

Sponsor: SkyePharma AG

Conditions Asthma

Interventions Fluticasone propionate 100 Fluticasone propionate/formoterol fumarate 100/10 Formoterol fumarate 10 Placebo

Updated 8 times since 2017 Last updated: Jun 8, 2011 Started: Jul 31, 2006 Primary completion: Apr 30, 2008 Completion: Apr 30, 2008

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Asthma, this trial is completed. The trial is conducted by SkyePharma AG and has accumulated 8 data snapshots since 2006. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

8 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Apr 2022 — Jul 2024 [monthly]

Completed PHASE3
Jan 2021 — Apr 2022 [monthly]

Completed PHASE3

▶ Show 3 earlier versions

Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Jul 2006

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

SkyePharma AG

Data source: SkyePharma AG

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Ajax, Canada , Asheville, United States , Austin, United States , Aventura, United States , Bellingham, United States , Bethesda, United States , Brockton, United States , Centennial, United States , Cherry Hill, United States , Colorado Springs, United States and 43 more locations