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NCT00532350 Clinical Trial

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

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:
A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of an Efficacious Dose of QAT370 Compared to Open-label Tiotropium Bromide Following Once Daily Dosing for 7 Days in COPD Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00532350
Other study ID # CQAT370A2103
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date July 2007
Est. completion date January 2008

Study information
Verified date September 2010
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 22
Est. completion date January 2008
Est. primary completion date
Accepts healthy volunteers No
Gender All
Age group 40 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Drug:
• QAT370

• Placebo

• Tiotropium

Locations
Country Name City State
Germany Novartis investigative site Berlin
Germany Novartis Investigative site Mannheim
Germany Novartis Investigative site Wiesbaden

Sponsors (1)
Lead Sponsor Collaborator
Novartis

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Forced expiratory volume in 1 second Days 1 and 7
Secondary Forced expiratory volume in 1 second and corresponding parameters for inspiratory capacity. Days 1 and 7
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