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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00532350
Recruitment Status : Completed
First Posted : September 20, 2007
Last Update Posted : September 2, 2010
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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 Type : Interventional  (Clinical Trial)
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 : July 2007
Actual Study Completion Date : January 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Forced expiratory volume in 1 second [ Time Frame: Days 1 and 7 ]

Secondary Outcome Measures :
  1. Forced expiratory volume in 1 second and corresponding parameters for inspiratory capacity. [ Time Frame: Days 1 and 7 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00532350

Novartis investigative site
Berlin, Germany
Novartis Investigative site
Mannheim, Germany
Novartis Investigative site
Wiesbaden, Germany
Sponsors and Collaborators
Principal Investigator: Novartis Investigative site

Responsible Party: External Affairs, Novartis Identifier: NCT00532350     History of Changes
Other Study ID Numbers: CQAT370A2103
First Posted: September 20, 2007    Key Record Dates
Last Update Posted: September 2, 2010
Last Verified: September 2010

Keywords provided by Novartis:
cycle ergometry
exercise testing

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Tiotropium Bromide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action