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
1 other identifier
interventional
22
1 country
3
Brief Summary
This study will assess the safety and tolerability of QAT370 compared to tiotropium in patients with COPD.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 chronic-obstructive-pulmonary-disease
Started Jul 2007
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2007
CompletedFirst Submitted
Initial submission to the registry
September 19, 2007
CompletedFirst Posted
Study publicly available on registry
September 20, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2008
CompletedDecember 19, 2020
September 1, 2010
September 19, 2007
December 16, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Forced expiratory volume in 1 second
Days 1 and 7
Secondary Outcomes (1)
Forced expiratory volume in 1 second and corresponding parameters for inspiratory capacity.
Days 1 and 7
Study Arms (3)
1
EXPERIMENTALQAT370
2
PLACEBO COMPARATORPlacebo
3
ACTIVE COMPARATORTiotropium
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novartislead
Study Sites (3)
Novartis investigative site
Berlin, Germany
Novartis Investigative site
Mannheim, Germany
Novartis Investigative site
Wiesbaden, Germany
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Novartis
Investigative site
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
September 19, 2007
First Posted
September 20, 2007
Study Start
July 1, 2007
Study Completion
January 1, 2008
Last Updated
December 19, 2020
Record last verified: 2010-09