Safety of Exercise and High-Dose Salbutamol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Receiving Therapeutic Doses of Indacaterol (QAB 149) and Salmeterol
Information source: Novartis
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Obstructive Pulmonary Disease
Intervention: QAB149 (Drug); Placebo (Drug); Salmeterol (Drug)
Phase: Phase 1/Phase 2
Status: Active, not recruiting
Sponsored by: Novartis Official(s) and/or principal investigator(s):
Novartis, Principal Investigator, Affiliation: Investigative site
Summary
This study will investigate the effect of exercise and high-dose salbutamol on the maximum
heart rate in patients with chronic obstructive pulmonary disease (COPD) receiving
therapeutic doses of indacaterol or placebo and salmeterol.
Clinical Details
Official title: A Double-Blind, Randomized, Cross-Over, Placebo-Controlled, 2-Part Study to Compare the Effect of Exercise and High-Dose Salbutamol on Maximal Heart-Rate in Patients With COPD Following Therapeutic Doses of Inhaled QAB149 and Salmeterol
Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Pharmacokinetics Study
Primary outcome: • Effect of exercise on maximal heart rate in patients with COPD receiving therapeutic doses of indacaterol and salmeterol
• Effect of high-dose salbutamol on maximal heart rate
Secondary outcome: • Cardiovascular safety of therapeutic doses of indacaterol and salmeterol
• Exercise effect on change in heart rate from pre-exercise
• Non-cardiovascular safety and tolerability
• Bronchodilator efficacy
Eligibility
Minimum age: 40 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients between 40 and 75 years of age diagnosed with COPD. Female patients must be
surgically sterilized, postmenopausal or using a double-barrier method of
contraception.
- Body mass index (BMI) must be within the range of 18 to 32.
Exclusion Criteria:
- Participation in any clinical investigation with experimental drug therapy within four
weeks prior to dosing or longer as required by local regulation.
- Donation or loss of 400 mL or more of blood within two months prior to dosing.
- Significant illness (other than respiratory) within two weeks prior to dosing.
- A past personal or close family (grandparents, parents and siblings) medical history
of heart abnormalities, heart attacks, or heart disease, including irregular
heartbeats and exercise-induced angina.
- Any medical condition that may interfere with exercise testing such as. arthritis
- History of clinically significant drug allergy or history of atopic allergy (asthma,
urticaria, eczematous dermatitis).
- A known hypersensitivity to the study drug or drugs similar to the study drug.
- History of immunocompromise, including a positive HIV, Hepatitis B or C test result.
- History of drug or alcohol abuse within the 12 months prior to dosing
- Any condition that in the opinion of the investigator may compromise patient safety,
interfere with evaluations, or preclude the completion of the trial.
Locations and Contacts
Novartis Investigative site, Antwerp, Belgium
Additional Information
Starting date: August 2007
Ending date: July 2008
Last updated: June 6, 2008
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