NCT00532350CompletedPhase 1
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Novartis
- Enrollment
- 22
- Locations
- 2
- Primary Endpoint
- Forced expiratory volume in 1 second
Study Overview
Brief Summary
This study will assess the safety and tolerability of QAT370 compared to tiotropium in patients with COPD.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 40 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
1
Experimental
QAT370
Intervention: QAT370 (Drug)
2
Placebo Comparator
Placebo
Intervention: Placebo (Drug)
3
Active Comparator
Tiotropium
Intervention: Tiotropium (Drug)
Outcomes
Primary Outcomes
Forced expiratory volume in 1 second
Time Frame: Days 1 and 7
Secondary Outcomes
- Forced expiratory volume in 1 second and corresponding parameters for inspiratory capacity.(Days 1 and 7)
Investigators
Study Sites (2)
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