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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01836471
• Date of registration: 17/04/2013
• Prospective Registration: Yes
• Primary sponsor: Novartis Pharmaceuticals
• Public title: A Study to Assess the Effect of QAW039 in Non-atopic Asthmatic Patients
• Scientific title: A Double-blind, Placebo-controlled, Study Examining the Effect of Orally Administered QAW039 (450 mg QD) on FEV1 and ACQ in Non-atopic, Asthmatic Patients With a Baseline, Pre-bronchodilator FEV1 of 40-80% Predicted, Inadequately Controlled With Low Dose ICS Therapy
• Date of first enrolment: May 2013
• Target sample size: 345
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01836471
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

Belgium, Colombia, Czech Republic, Germany, India, Korea, Republic of, Poland, Romania, South Africa, United States

Contacts

• Name: Richard Kay
• Affiliation: Novartis Pharmaceuticals

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Drug: Placebo QAW039

Drug: QAW039

Drug: Fluticasone 100 mcg

Drug: Fluticasone 250 mcg

Primary Outcome(s)

Change From Baseline in Trough FEV1 (L) in Non-atopic Patients at Week 12 - Full Analysis Set [Time Frame: baseline,12 weeks]

Secondary Outcome(s)

Change From Baseline in ACQ-6 Score at Week 12 Non-atopic and Atopic Patients at Week 12 - Full Analysis Set [Time Frame: baseline,12 weeks]

Change From Baseline in ACQ-6 Score at Week 12 Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set [Time Frame: baseline,12 weeks]

Change From Baseline in Trough FEV1 (L) in Atopic Patients at Week 12 - Full Analysis Set [Time Frame: baseline,12 weeks]

Change From Baseline in Trough FEV1 (L) in Non-atopic Compared to Atopic Patients at Week 12 - Full Analysis Set [Time Frame: baseline,12 weeks]

Secondary ID(s)

2012-003995-38

CQAW039A2214

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 20/03/2017
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01836471