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Safety of Exercise and High-Dose Salbutamol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Receiving Therapeutic Doses of Indacaterol (QAB 149) and Salmeterol
This study has been completed.
Study NCT00531050   Information provided by Novartis
First Received: September 17, 2007   Last Updated: July 15, 2008   History of Changes

September 17, 2007
July 15, 2008
August 2007
 
• 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 ]
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.
Complete list of historical versions of study NCT00531050 on ClinicalTrials.gov Archive Site
• 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 ]
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.
 
Safety of Exercise and High-Dose Salbutamol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Receiving Therapeutic Doses of Indacaterol (QAB 149) and Salmeterol
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.

 
Phase I, Phase II
Interventional
Treatment, Randomized, Double Blind (Subject, Investigator), Active Control, Crossover Assignment, Pharmacokinetics Study
Chronic Obstructive Pulmonary Disease
  • Drug: QAB149
  • Drug: Placebo
  • Drug: Salmeterol
  • Experimental: QAB149
  • Placebo Comparator: Placebo
  • Active Comparator: Salmeterol
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Completed
24
June 2008
 

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.
Both
40 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
NCT00531050
External Affairs, Novartis
CQAB149B2217
Novartis
 
Principal Investigator: Novartis Investigative site
Novartis
July 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP