Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
A Randomized, Double-blind, Double-dummy, Three Period Incomplete Cross-over Study to Evaluate the Safety and Efficacy of Multiple Daily Doses of QAX028 as Compared to Tiotropium Bromide (Positive Control) and Placebo in COPD Patients
Verified date | May 2012 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will assess the bronchodilator effects of multiple doses of QAX028 at two different dose levels when compared to tiotropium and placebo in a COPD population.
Status | Completed |
Enrollment | 62 |
Est. completion date | August 2010 |
Est. primary completion date | August 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility | Inclusion Criteria: - Diagnosis of COPD according to GOLD guidelines - Post-bronchodilator 30%=FEV1<80% of predicted normal and ost-bronchodilator FEV1/FVC <0.7 - Smoking history of at least 10 pack years Exclusion Criteria: - Requiring oxygen therapy on a daily basis - Exacerbation of airway disease in the 6 weeks prior to screening or between screening and dosing - Lung reduction surgery - Respiratory tract infection in the 6 weeks prior to screening - Significant cardiac history - History of asthma with onset of symptoms prior to age 40 years - Active use of certain COPD medications, beta blockers Other protocol-defined inclusion/exclusion criteria may apply |
Country | Name | City | State |
---|---|---|---|
United States | Advanced Clinical Research Institute, 1211 W. La Palma Ave | Anaheim | California |
United States | New Orleans Center for Clinical Research - Knoxville, 1928 Alcoa Highway | Knoxville | Tennessee |
United States | Sneeze, Wheeze, & Itch Associates, LLC, 2010 Jacobssen Drive | Normal | Illinois |
United States | Spartanburg Medical Research, 485 Simuel Road | Spartanburg | South Carolina |
Lead Sponsor | Collaborator |
---|---|
Novartis Pharmaceuticals |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Measure: Compare the efficacy of QAX028 at a high dose, as measured by trough forced expiratory volume in 1 second (FEV1), to tiotropium | 7 days treatment | ||
Secondary | Compare the efficacy of QAX028 at a low dose, as measured by trough FEV1, to tiotropium | 7 days treatment | ||
Secondary | Measure: Compare the efficacy of QAX028 at two dose levels, as measured by trough FEV1, to placebo | 7 days treatment | ||
Secondary | Measure: Evaluate the safety and tolerability of two dose levels of QAX028 in COPD patients | 7 days treatment | ||
Secondary | Measure: Evaluate the pharmacokinetics of multiple inhaled does of QAX028 | 7 days treatment | ||
Secondary | Measure: Assess bronchodilatory profile, as measured by FEV1, of multiple inhaled doses of QAX028 in COPD patients | 7 days treatment |
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