Safety of Exercise and High-dose Salbutamol in Patients With Chronic Obstructive Pulmonary Disease (COPD) Receiving Therapeutic Doses of Indacaterol (QAB 149) and Salmeterol
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Intervention: Indacaterol; Placebo; Salmeterol
Intervention description: Single dose of indacaterol 300μg capsule via Concept 1 inhaler device at approximately the same time in the morning (i.e. between 8am and 9am).; Single dose indacaterol matching placebo via Concept 1 device; Single dose salmeterol 50μg via the Diskus dry powder inhaler (DPI) in part 1 of the study. Morning single inhalational dose and an evening single inhalation dose of salmeterol 50μg via the Diskus DPI in part 2 of the study.
Intervention MeSH terms: Salmeterol Xinafoate
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Enrollment: 27.0
Sex: All
Minimum age: 40 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: COPD; cycle ergometry; exercise testing; spirometry; cardiovascular; salbutamol; indacaterol; chronic obstructive pulmonary disease

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.
    

Eligibility 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