A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients

Novartis

Status and phase: Completed; Phase 2

Conditions: Asthma

Treatments: Drug: QAW039; Drug: Fluticasone 100 mcg; Drug: Placebo QAW039; Drug: Fluticasone 250 mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT01836471

CQAW039A2214

2012-003995-38 (EudraCT Number)

Details and patient eligibility

About

The purpose of the study was to assess the clinical effect of QAW039 in non-atopic asthmatics taking low dose Inhaled Corticosteroid (ICS) as background therapy.

Full description

This was a multi-centre, randomised, placebo-controlled, double blind, 3-arm study designed to compare the efficacy and safety of a once daily dose of QAW039 with placebo in non-atopic and atopic asthmatics both inadequately controlled despite receiving a low dose ICS background therapy, over a 12 week treatment period. Efficacy and safety of a once daily dose of QAW039 was also compared with an increased dose of ICS in atopic asthmatics taking low dose ICS as background therapy.

Enrollment: 345 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent must be obtained before any assessment is performed
• Patients with a diagnosis of persistent asthma (according to Global Initiative for Asthma 2011) for a period of at least 6 months prior to screening
• Patients with a pre-bronchodilator Forced Expiratory Volume In One Second (FEV1) value of 40% to 80% of individual predicted value at screening and prior to treatment
• An Asthma Control Questionnaire score ≥ 1.5 prior to treatment
• Demonstration of reversible airway obstruction

Exclusion criteria

• Pregnant or nursing (lactating) women
• Acute illness other than asthma at the start of the study
• Patients with clinically significant laboratory abnormalities at screening
• Patients with clinically significant condition which may compromise subject safety or interfere with study evaluation
• Use of other investigational drugs at the time of enrollment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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345 participants in 5 patient groups, including a placebo group

QAW039 450 mg qd Non-atopic

Experimental group

Description:

QAW039 450 mg (3 capsules of QAW039 150 mg) qd combined with background ICS (100 μg fluticasone, bid). Non-atopic patients randomized in ratio of approximately 1:1.

Treatment:

Drug: QAW039

Drug: Fluticasone 100 mcg

Placebo Non-atopic

Placebo Comparator group

Description:

Placebo to QAW039 (3 capsules of Placebo of QAW039 150 mg) combined with background ICS (100 μg fluticasone, bid). Non-atopic randomized in ratio of approximately 1:1.

Treatment:

Drug: Placebo QAW039

Drug: Fluticasone 100 mcg

QAW039 450 mg qd Atopic

Experimental group

Description:

QAW039 450 mg (3 capsules of QAW039 150 mg) qd combined with background ICS (100 μg fluticasone, bid). Atopic patients randomized in a ratio of approximate 1:1:1

Treatment:

Drug: QAW039

Drug: Fluticasone 100 mcg

Fluticasone 150 mcg bid Atopic

Active Comparator group

Description:

Placebo to QAW039 (3 capsules of Placebo of QAW039 150 mg) combined with 150 μg ICS and with background ICS (100 μg fluticasone, bid). As a consequence total ICS was 250 μg fluticasone bid. Atopic patients randomized in ratio of approximately 1:1:1

Treatment:

Drug: Placebo QAW039

Drug: Fluticasone 250 mcg

Placebo Atopic

Placebo Comparator group

Description:

Placebo to QAW039 (3 capsules of Placebo of QAW039 150 mg) combined with background ICS (100 μg fluticasone, bid). Atopic patients andomized in ratio of approximately 1:1:1

Treatment:

Drug: Placebo QAW039

Drug: Fluticasone 100 mcg