Back to resultsSafety and Tolerability QAT370 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease
Primary Purpose
Chronic Obstructive Pulmonary Disease
Status
Completed
Phase
Phase 1
Locations
Germany
Study Type
Interventional
Intervention
QAT370
Placebo
Tiotropium
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, pharmacokinetics, plethysmography, cycle ergometry, exercise testing, spirometry
Eligibility 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
Sites / Locations
- Novartis investigative site
- Novartis Investigative site
- Novartis Investigative site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Active Comparator
Arm Label
1
2
3
Arm Description
QAT370
Placebo
Tiotropium
Outcomes
Primary Outcome Measures
Forced expiratory volume in 1 second
Secondary Outcome Measures
Forced expiratory volume in 1 second and corresponding parameters for inspiratory capacity.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00532350
Brief Title
Safety and Tolerability QAT370 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease
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 Type
Interventional
2. Study Status
Record Verification Date
September 2010
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
January 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study will assess the safety and tolerability of QAT370 compared to tiotropium in patients with COPD.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, pharmacokinetics, plethysmography, cycle ergometry, exercise testing, spirometry
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
QAT370
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
3
Arm Type
Active Comparator
Arm Description
Tiotropium
Intervention Type
Drug
Intervention Name(s)
QAT370
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Type
Drug
Intervention Name(s)
Tiotropium
Primary Outcome Measure Information:
Title
Forced expiratory volume in 1 second
Time Frame
Days 1 and 7
Secondary Outcome Measure Information:
Title
Forced expiratory volume in 1 second and corresponding parameters for inspiratory capacity.
Time Frame
Days 1 and 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Investigative site
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis investigative site
City
Berlin
Country
Germany
Facility Name
Novartis Investigative site
City
Mannheim
Country
Germany
Facility Name
Novartis Investigative site
City
Wiesbaden
Country
Germany
12. IPD Sharing Statement
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2637
Description
Results for CQAT370A2103 can be found on the Novartis Clinical Trial Results Website
Learn more about this trial
Safety and Tolerability QAT370 Compared to Tiotropium in Patients With Chronic Obstructive Pulmonary Disease
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