Overview

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