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

Sponsor

Novartis (Industry)

Overall Status

Completed

CT.gov ID

NCT00532350

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

7.3

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: QAT370 Drug: Placebo Drug: Tiotropium	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Primary Purpose:

Treatment

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

Study Start Date :

Jul 1, 2007

Actual Study Completion Date :

Jan 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 QAT370	Drug: QAT370
Placebo Comparator: 2 Placebo	Drug: Placebo
Active Comparator: 3 Tiotropium	Drug: Tiotropium

Arm

Intervention/Treatment

Experimental: 1

QAT370

Drug: QAT370

Placebo Comparator: 2

Placebo

Drug: Placebo

Active Comparator: 3

Tiotropium

Drug: Tiotropium

Outcome Measures

Primary Outcome Measures

Forced expiratory volume in 1 second [Days 1 and 7]

Secondary Outcome Measures

Forced expiratory volume in 1 second and corresponding parameters for inspiratory capacity. [Days 1 and 7]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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