Persistent Asthma Clinical Trial
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
| Verified date | August 2013 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This study will assess the safety, efficacy and pharmacokinetics of QAW039 in steroid-free patients with mild to moderate persistent asthma.
| Status | Completed |
| Enrollment | 170 |
| Est. completion date | September 2011 |
| Est. primary completion date | September 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Novartis Investigative Site | Jambes | |
| 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 | |
| Korea, Republic of | Novartis Investigative Site | Seoul | |
| Romania | Novartis Investigative Site | Bucharest | |
| United States | Novartis Investigative Site | Bellevue | Nebraska |
| United States | Novartis Investigative Site | Berlin | New Jersey |
| United States | Novartis Investigative Site | Dallas | Texas |
| United States | Novartis Investigative Site | Encinitas | California |
| United States | Novartis Investigative Site | Huntington Beach | California |
| United States | Novartis Investigative Site | Los Angeles | California |
| United States | Novartis Investigative Site | Los Angeles | California |
| United States | Novartis Investigative Site | Medford | Oregon |
| United States | Novartis Investigative Site | Mission Viejo | California |
| United States | Novartis Investigative Site | North Dartmouth | Massachusetts |
| United States | Novartis Investigative Site | Raleigh | North Carolina |
| United States | Novartis Investigative Site | San Diego | California |
| United States | Novartis Investigative Site | San Diego | California |
| United States | Novartis Investigative Site | San Jose | California |
| United States | Novartis Investigative Site | Skillman | New Jersey |
| United States | Novartis Investigative Site | Stockbridge | Georgia |
| United States | Novartis Investigative Site | Stockton | California |
| United States | Novatis Investigative Site | Upland | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
United States, Belgium, Germany, Korea, Republic of, Romania,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in trough forced expiratory volume in 1 second (FEV1) compared to placebo. | 28 days | ||
| Secondary | To assess the safety of a 28 day administration of QAW039 compared to placebo, measured by vital signs, laboratory evaluations and electrocardiograms. | 28 days |
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