A Phase III, randomized, double-blind, active controlled, parallel group study, comparing the efficacy, safety and tolerability of the fixed dose combination FF/UMEC/VI with the fixed dose dual combination of FF/VI, administered once-daily via a dry powder inhaler in subjects with inadequately controlled asthma (study 205715)

Phase 3

Completed

• Conditions: asthma; bronchial asthma; 10006436

• Registration Number: NL-OMON45467
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

* Inadequately controlled asthma (ACQ-6 score *1.5) at Visit 2.
* A best pre-bronchodilator morning (AM) FEV1 *30% and <85% of the predicted normal value at Visit 2. Predicted values will be based upon the ERS Global Lung Function Initiative.

Exclusion Criteria

* Occurrence of a culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear during the run-in period that led to a change in asthma management or, in the opinion of the Investigator, is expected to affect the subject*s asthma status or the subject*s ability to participate in the study.
* Evidence of a severe exacerbation during screening or the run-in period, defined as deterioration of asthma requiring the use of systemic corticosteroids for at least 3 days (1) or an in-patient hospitalization or emergency department visit due to asthma that required systemic corticosteroids.
(1) For subjects on maintenance systemic corticosteroids, at least double the existing maintenance dose for at least 3 days is required.
* Changes in asthma medication (excluding run-in medication and salbutamol inhalation aerosol provided at Visit 1).
* Pregnancy or breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Trough FEV1 at week 24.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Annualized rate of moderate/severe asthma exacerbations. FEV1 3h post dose<br /><br>(week 24), Mean change from baseline in ACQ-7, SGRQ, total score at Week 24.<br /><br>Mean change from baseline in Evaluating Respiratory Symptoms (E-RS) total score<br /><br>over the first 24 weeks of the treatment period. Adverse effects.</p><br>