Safety of Exercise and High-dose Salbutamol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Receiving Therapeutic Doses of Indacaterol (QAB 149) and Salmeterol

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”

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.

Intervention(s) in this Clinical Trial

• Drug: QAB149
• Drug: Placebo
• Drug: Salmeterol

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • QAB149
• Placebo Comparator: 2
  • Placebo
• Active Comparator: 3
  • Salmeterol

Primary Measures

• • 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
  • Time Frame: End of study
    

Secondary Measures

• • 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
  • Time Frame: End of study
    

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 40 Years

Maximum Age for this Clinical Trial: 75 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Novartis Industry

Overall Clinical Trial Officials and Contacts

Novartis Principal Investigator Investigative site  

Information obtained from ClinicalTrials.gov on February 09, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00531050

Study ID Number: CQAB149B2217

ClinicalTrials.gov Identifier: NCT00531050

Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products