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Efficacy, Safety, and Pharmacokinetics of QAW039

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01253603
Recruitment Status : Completed
First Posted : December 3, 2010
Last Update Posted : November 21, 2013
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
This study will assess the safety, efficacy and pharmacokinetics of QAW039 in steroid-free patients with mild to moderate persistent asthma.

Condition or disease Intervention/treatment 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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (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
Study Start Date : November 2010
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
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



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

Secondary Outcome Measures :
  1. 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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01253603


Locations
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United States, California
Novartis Investigative Site
Encinitas, California, United States, 92024
Novartis Investigative Site
Huntington Beach, California, United States, 92647
Novartis Investigative Site
Los Angeles, California, United States, 90025
Novartis Investigative Site
Los Angeles, California, United States, 90048
Novartis Investigative Site
Mission Viejo, California, United States, 92691
Novartis Investigative Site
San Diego, California, United States, 92120
Novartis Investigative Site
San Diego, California, United States, 92123
Novartis Investigative Site
San Jose, California, United States, 95117
Novartis Investigative Site
Stockton, California, United States, 95207
United States, Georgia
Novartis Investigative Site
Stockbridge, Georgia, United States, 30281
United States, Massachusetts
Novartis Investigative Site
North Dartmouth, Massachusetts, United States, 02747
United States, Nebraska
Novartis Investigative Site
Bellevue, Nebraska, United States, 68123
United States, New Jersey
Novartis Investigative Site
Berlin, New Jersey, United States, 08009
Novartis Investigative Site
Skillman, New Jersey, United States, 08558
United States, North Carolina
Novartis Investigative Site
Raleigh, North Carolina, United States, 27607
United States, Oregon
Novartis Investigative Site
Medford, Oregon, United States, 97504
United States, Pennsylvania
Novatis Investigative Site
Upland, Pennsylvania, United States, 19013
United States, Texas
Novartis Investigative Site
Dallas, Texas, United States, 75231
Belgium
Novartis Investigative Site
Jambes, Belgium
Germany
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Frankfurt, Germany
Novartis Investigative Site
Hamburg, Germany
Novartis Investigative Site
Koeln, Germany
Novartis Investigative Site
Wiesbaden, Germany
Korea, Republic of
Novartis Investigative Site
Seoul, Korea, Republic of
Romania
Novartis Investigative Site
Bucharest, Romania
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01253603    
Other Study ID Numbers: CQAW039A2201
2010-020177-16 ( EudraCT Number )
First Posted: December 3, 2010    Key Record Dates
Last Update Posted: November 21, 2013
Last Verified: August 2013
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Asthma
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Indoleacetic Acids
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
Plant Growth Regulators
Growth Substances