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

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study investigated 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, salmeterol and placebo.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis
• Treatments: Albuterol; Salmeterol Xinafoate

Criteria

Inclusion Criteria:

• Patients between 40 and 75 years of age diagnosed with chronic obstructive pulmonary disease (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 medical history of, or a family history (grandparents, parents and siblings) of a prolonged QT-interval syndrome or a prolonged QT-interval at screening.

• Any clinically significant medical abnormalities (excluding COPD) limiting ability to perform standardized exercise protocol on cycle ergometer will exclude the patient. For example, 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 conditions that in the opinion of the investigator may compromise patient safety, interfere with evaluations, or preclude the completion of the trial.

Other protocol-defined inclusion/exclusion criteria may apply