Clinical Trials/NCT01437735

NCT01437735

Completed

Phase 2

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.

Novartis Pharmaceuticals1 site in 1 country1,043 target enrollmentAugust 2011

ConditionsAsthma

InterventionsQAW039 Montelukast Placebo

DrugsQAW039 Montelukast Placebo

Overview

Phase: Phase 2
Intervention: QAW039
Conditions: Asthma
Sponsor: Novartis Pharmaceuticals
Enrollment: 1043
Locations: 1
Primary Endpoint: Change in trough Forced Expiratory Volume in 1 second (FEV1) from baseline to week 12
Status: Completed
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to demonstrate a clinically significant improvement in Forced Expiratory Volume in one second (FEV1) in moderate to severe allergic asthmatics inadequately controlled by Inhaled Corticosteroid (ICS) therapy. Patients will be treated with QAW039, an active comparator, or placebo. This will be a randomized, placebo-controlled, dose-ranging, multi-centre trial.

Registry

clinicaltrials.gov

Start Date

August 2011

End Date

November 2013

Last Updated

5 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Physician diagnosis of asthma, as per the Global Initiative for Asthma (GINA) (2009) guidelines, and currently prescribed Inhaled Corticosteroids (ICS) therapy.
•Patients with a pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) value of 40% to 80% of individual predicted value.
•Patients should be allergic or atopic, as diagnosed historically or prior to entry into the study.
•Patients who are demonstrated to have reversible airway obstruction or airways hyper-reactivity or have shown either of such responses in previous test(s) within the last year.
•An Asthma Control Questionnaire (ACQ) score ≥ 1.5 at randomization.

Exclusion Criteria

•Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (\> 5 mIU/mL).
•Patients with serious co-morbidities including uncontrolled diabetes (HbA1c≥8%), heart failure, cancer, neurodegenerative diseases, rheumatoid arthritis and other autoimmune diseases, other lung diseases including chronic bronchitis, chronic obstructive pulmonary diseases or emphysema or other conditions characterized by eosinophilia and pulmonary symptoms (i.e. Churg-Strauss syndrome, allergic bronchopulmonary aspergillosis, eosinophilic pneumonia, etc.).
•Acute illness other than asthma at the start of the study
•History of life-threatening asthma, including a history of significant hypercarbia (pCO2\>45mmHg), prior intubation, respiratory arrest, or seizures as a result of asthma.
•Patients who have had a respiratory tract infection within 4 weeks of the screening visit. Patients who develop a respiratory tract infection between screening and the randomization visit must be screen failed, and may be permitted to re-enroll at a later date.
•Current smokers or ex-smokers who stopped smoking within 6 months prior to screening or have a smoking history of ≥ 10 pack years.

Arms & Interventions

QAW039 po dose 1

Intervention: QAW039

QAW039 po dose 8

Intervention: QAW039

QAW039 po dose 2

Intervention: QAW039

QAW039 po dose 3

Intervention: QAW039

QAW039 po dose 4

Intervention: QAW039

QAW039 po dose 5

Intervention: QAW039

QAW039 po dose 6

Intervention: QAW039

QAW039 po dose 7

Intervention: QAW039

QAW039 po dose 9

Intervention: QAW039

QAW039 po dose 10

Intervention: QAW039

QAW039 po dose 11

Intervention: QAW039

QAW039 po dose 12

Intervention: QAW039

QAW039 po dose 13

Intervention: QAW039

Montelukast po 10 mg

Comparator leukotriene receptor antagonist (LRTA)

Intervention: Montelukast

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

Change in trough Forced Expiratory Volume in 1 second (FEV1) from baseline to week 12

Time Frame: Baseline and week 12

Forced Expiratory Volume in 1 second (FEV1) (measured in litters), and the trough measurement is taken 24 hours after morning dose on the previous day.

Secondary Outcomes

Comparison of efficacy of QAW039 with that of active comparator as an add-on therapy to Inhaled Corticosteroids (ICS)(Baseline and week 12)
Change in Asthma Control Questionnaire (ACQ) score from baseline to week 12(Baseline and week 12)
Comparison of vital signs, ECG, laboratory tests and adverse events across QAW039 doses and placebo.(Baseline and week 12)
Assess the effect of QAW039 on asthma symptoms as measured by asthma control diary.(Baseline and week 12)
Change in Forced Expiratory Volume in 1 second (FEV1) from baseline to weeks 2, 4 and 8.(Baseline, week 2, week 4 and week 8)
Change in the Asthma Control Questionnaire (ACQ) score from baseline to weeks 2, 4 and 8.(Baseline, week 2, week 4 and week 8)
Change in the dose response relationship among QAW039 doses with respect to Forced Expiratory Volume in 1 second (FEV1) after 12 weeks treatment.(Baseline and week 12)