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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00532350

Enrollment

Registered

2007-09-20

Start date

2007-07-31

Completion date

2008-01-31

Last updated

2020-12-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, pharmacokinetics, plethysmography, cycle ergometry, exercise testing, spirometry

Brief summary

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

Interventions

DRUGQAT370

DRUGPlacebo

DRUGTiotropium

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

40 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame
Forced expiratory volume in 1 second	Days 1 and 7

Secondary

Measure	Time frame
Forced expiratory volume in 1 second and corresponding parameters for inspiratory capacity.	Days 1 and 7

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026