Trial intelligence / Profile preview

FlutiForm versus fluticasone inhalers in moderate to severe asthma

2007-005653-37Phase 3

Key facts

Status
Terminated
Start
Dec 2007
Countries
1
Sponsor
Skyepharma
Modality
Orthosteric Ligands → Classical Binding Small Molecules → Small Molecules
Conditions
asthma
01

Overview

Phase 3, randomised, double-blind trial of fluticasone propionate + formoterol and fluticasone propionate in asthma (3 arms), sponsored by Skyepharma. Started Dec 2007; status: terminated.

02

Design

3 arms
Study design
RandomizedDouble-blind
  • FlutiForm combination inhaler

    Fluticasone propionate + formoterol fumarate combination inhaler twice daily.

  • SKP fluticasone inhaler

    Fluticasone propionate monotherapy inhaler twice daily.

  • Flovent HFA inhaler

    Commercial fluticasone propionate monotherapy inhaler twice daily.

03

Who it enrols

Adolescents and adults aged 12 years or older with moderate to severe asthma were eligible. Patients with recent life-threatening or near-fatal asthma, asthma-related hospitalization or intubation within the past year, or emergency room visit for asthma within the prior 3 months were excluded.

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