Efficacy, Safety, and Pharmacokinetics of QAW039

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01253603
First received: December 1, 2010
Last updated: October 29, 2013
Last verified: August 2013
  Purpose

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 (Subject, Caregiver, 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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: Yes ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01253603

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

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01253603     History of Changes
Other Study ID Numbers: CQAW039A2201, 2010-020177-16
Study First Received: December 1, 2010
Last Updated: October 29, 2013
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
Russia: Ministry of Health of the Russian Federation
Russia: Pharmacological Committee, Ministry of Health
Romania: National Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Bulgaria: Bulgarian Drug Agency
Hungary: National Institute of Pharmacy
Belgium: Federal Agency for Medicinal Products and Health Products
Turkey: Ministry of Health
Taiwan: Department of Health
Taiwan: Institutional Review Board
Taiwan: National Bureau of Controlled Drugs
South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Novartis:
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents

ClinicalTrials.gov processed this record on October 02, 2014