A randomized, placebo-controlled, dose-ranging, multi-centre trial of QAW039 (1-450 mg p.o.) to investigate the effect on FEV1 and ACQ in patients with moderate-to-severe, persistent, allergic asthma, inadequately controlled with ICS therapy (CQAW039A2206)

Phase 2

Completed

• Conditions: asthma; allergic asthma; 10006436

• Registration Number: NL-OMON37185
• Lead Sponsor: ovartis Pharma BV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

• Male or female adults aged 18-65 years.
• Asthma as per [GINA] guidelines, and currently prescribed ICS therapy.
• Pre-bronchodilator FEV1 40% to 80% of predicted at screening and at randomization. Value at the randomization should be within 15% of the screening FEV1.
• Patients should be allergic or atopic, as diagnosed historically or prior to entry into the study.
• Reversible airway obstruction or airways hyper-reactivity or have shown either of such responses in previous test(s) within the last 5 years.
• ACQ score >= 1.5 at randomization.

Exclusion Criteria

• Recent use of other investigational drugs (see protocol page 13 for details).
• History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes (CRTh2 antagonists).
• History of long QT syndrome or QTc measured at Visit 2 (Fridericia method) is prolonged (>450 ms for males and females).
• History of malignancy (see protocol page 14 for exceptions) in the last 5 years.
• Pregnancy and breast feeding. Inadequate contraception, if relevant.
• Serious co-morbidities (see protocol page 14 for details).

Study & Design

• Study Type: Interventional
• Study Design: Not specified