A Phase IIa Randomized, Placebo-Controlled, Double-Blind (Sponsor Open) Study to Investigate the Clinical Efficacy, Safety, and Tolerability of Nemiralisib (GSK2269557) in Symptomatic COPD Participants with a History of Exacerbations (205739)

Phase 2

Completed

• Conditions: COPD; chronic obstructive airway disease; 10006436

• Registration Number: NL-OMON45791
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 20

Inclusion Criteria

* Males and females * 40 and * 80 years of age.
* Established clinical history of COPD. See protocol page 37-38 for details.
* *2 moderate or *1 severe COPD exacerbation(s) in the preceding 12 months. See protocol page 38 for details.
* Current or former cigarette smoker with a history of *10 pack-years.
* A score of *10 on the COPD Assessment Test (CAT) at Screening.
* Existing prescribed inhaled COPD maintenance therapy must be a stable daily inhaled COPD maintenance therapy for at least 3 months prior to Screening. See protocol page 38 for details.
* Post-bronchodilator FEV1/FVC ratio * 0.70 and post-bronchodilator FEV1 * 80% of predicted in the past 5 years..
* No antibiotics and/or oral corticosteroids for a COPD exacerbation within 6 weeks prior to Screening.
* Female participant of childbearing potential who agrees to follow the contraceptive guidance in appendix 5 of the protocol. See protocol page 38-39 for details.

Exclusion Criteria

* Asthma.
* Pneumonia (chest X-ray or CT confirmed) within the last 3 months prior to Screening
* Other respiratory disorders or other diseases, see protocol page 39-40 for details.
* Prior/Concomitant Therapies, see protocol page 40-42 for details.
* Prior/Concurrent Clinical Study Experience: see protocol page 42-43 for details.
* Pregnancy or breastfeeding.

Study & Design

• Study Type: Interventional
• Study Design: Not specified