Safety and Tolerability QAT370 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease

• Status: Completed
• Trial end date: 2008-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will assess the safety and tolerability of QAT370 compared to tiotropium in patients with COPD.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Tiotropium Bromide

Criteria

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