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Efficacy, Safety, and Pharmacokinetics of QAW039

This study has been completed.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals ) Identifier:
First received: December 1, 2010
Last updated: October 29, 2013
Last verified: August 2013
This study will assess the safety, efficacy and pharmacokinetics of QAW039 in steroid-free patients with mild to moderate persistent asthma.

Condition Intervention Phase
Persistent Asthma
Drug: QAW039 capsules once daily for 28 days
Drug: Placebo to QAW039 capsules once daily for 28 days
Drug: Fluticasone propionate inhaler twice daily for 28 days
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized, Placebo-controlled, Parallel Group Study to Assess the Efficacy, Safety, and Pharmacokinetics of QAW039 in Steroid-free Patients With Mild to Moderate Persistent Asthma

Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change in trough forced expiratory volume in 1 second (FEV1) compared to placebo. [ Time Frame: 28 days ]

Secondary Outcome Measures:
  • To assess the safety of a 28 day administration of QAW039 compared to placebo, measured by vital signs, laboratory evaluations and electrocardiograms. [ Time Frame: 28 days ]

Enrollment: 170
Study Start Date: November 2010
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
QAW039 capsules once daily for 28 days
Drug: QAW039 capsules once daily for 28 days
Experimental: 2
Placebo to QAW039 capsules once daily for 28 days
Drug: Placebo to QAW039 capsules once daily for 28 days
Experimental: 3
Fluticasone propionate inhaler twice daily for 28 days
Drug: Fluticasone propionate inhaler twice daily for 28 days


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with a medical history of mild to moderate persistent allergic asthma.
  • Patients must weigh at least 45 kg to participate in the study, and must have abody mass index (BMI) of >17 kg/m2.
  • Female patients must be surgically sterilized, postmenopausal or using a double-barrier method of contraception

Exclusion Criteria:

  • Women of child-bearing potential.
  • Smokers defined as history of smoking in the previous 6 months or a smoking history of more than 10 pack years, a pack year being defined as smoking the equivalent of 20 cigarettes - a pack - every day for the period of 1 year
  • Patients with severe persistent asthma

Other protocol-defined inclusion/exclusion criteria may apply.

  Contacts and Locations
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Please refer to this study by its identifier: NCT01253603

  Show 26 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Novartis Pharmaceuticals Identifier: NCT01253603     History of Changes
Other Study ID Numbers: CQAW039A2201
2010-020177-16 ( EudraCT Number )
Study First Received: December 1, 2010
Last Updated: October 29, 2013

Keywords provided by Novartis:

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents processed this record on April 24, 2017