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

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00532350
First received: September 19, 2007
Last updated: September 1, 2010
Last verified: September 2010
History of Changes
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novartis:

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

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

Enrollment: 22
Study Start Date: July 2007
Study Completion Date: January 2008
Arms Assigned Interventions
Experimental: 1
QAT370
 Drug: QAT370
Placebo Comparator: 2
Placebo
 Drug: Placebo
Active Comparator: 3
Tiotropium
 Drug: Tiotropium

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00532350

Locations
Germany
Novartis investigative site
Berlin, Germany
Novartis Investigative site
Mannheim, Germany
Novartis Investigative site
Wiesbaden, Germany
Sponsors and Collaborators
Novartis
Investigators
Principal Investigator: Novartis Investigative site
  More Information

No publications provided

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00532350     History of Changes
Other Study ID Numbers: CQAT370A2103
Study First Received: September 19, 2007
Last Updated: September 1, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Novartis:
COPD
pharmacokinetics
plethysmography
 cycle ergometry
exercise testing
spirometry

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

ClinicalTrials.gov processed this record on June 18, 2013