Safety and Tolerability QAT370 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease
Phase 1
Completed
- Conditions
- Chronic Obstructive Pulmonary Disease
- Interventions
- Registration Number
- NCT00532350
- Lead Sponsor
- Novartis
- Brief Summary
This study will assess the safety and tolerability of QAT370 compared to tiotropium in patients with COPD.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 22
Inclusion Criteria
- Patients between 40 and 80 years of age with controlled COPD.
- Women must be surgically sterilized or postmenopausal. Additional birth control and post-menopausal information will be available at time of enrollment.
- Body mass index (BMI) must be within the range of 18 to 32 kg/m2
Exclusion Criteria
- Participation in any interventional clinical investigation with 4 weeks of study start
- Blood loss or donation of 400 mL or more within 2 months of study start Significant illness (other than respiratory) within 2 weeks of study start
- Past medical personal or close family history of clinically significant ECG abnormalities
- Any medical condition that may interfere with exercise testing or that may make spirometry unsafe
- A known hypersensitivity to the drug.
- History of immunocompromise, including a positive HIV test result.
- History of drug or alcohol abuse within 12 months of study start
- Any condition that may compromise patient safety
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description 1 QAT370 QAT370 2 Placebo Placebo 3 Tiotropium Tiotropium
- Primary Outcome Measures
Name Time Method Forced expiratory volume in 1 second Days 1 and 7
- Secondary Outcome Measures
Name Time Method Forced expiratory volume in 1 second and corresponding parameters for inspiratory capacity. Days 1 and 7
Trial Locations
- Locations (2)
Novartis investigative site
🇩🇪Berlin, Germany
Novartis Investigative site
🇩🇪Wiesbaden, Germany