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OpenTrials
Completed

NCT Number: NCT00532350

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

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

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Key information

Conditions

Chronic Obstructive Pulmonary Disease Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Novartis investigative site, Berlin, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

QAT370

Drug

Placebo

Drug

Tiotropium

Drug

Primary outcomes

  1. Forced expiratory volume in 1 second

    Time frame: Days 1 and 7

Secondary outcomes

  1. Forced expiratory volume in 1 second and corresponding parameters for inspiratory capacity.

    Time frame: Days 1 and 7

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Important dates

Study start
2007
Study completion
2008
First posted
Sep 20, 2007
Registry last updated
Dec 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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