Completed PHASE3 INTERVENTIONAL 3-arm NCT00394199

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

A Randomized, Double-blind, Active-controlled, Parallel Group, 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 Fluticasone (100 µg Twice Daily) and Formoterol (10 µg Twice Daily) Alone in Adolescent & 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

Updated 8 times since 2017 Last updated: Jun 8, 2011 Started: Jun 30, 2006 Primary completion: Feb 29, 2008 Completion: Feb 29, 2008

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

Listed as NCT00394199, this PHASE3 trial focuses on Asthma and remains completed. Sponsored by SkyePharma AG, it has been updated 8 times since 2006, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

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

Jun 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

Asheville, United States , Bethesda, United States , Birmingham, United States , Chattanooga, United States , Cincinnati, United States , Denver, United States , Easton, United States , El Paso, United States , Elizabeth, United States , Greenfield, United States and 30 more locations