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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 24

Inclusion Criteria

- Male and female patients aged 40 to 75 years of age with a diagnostics of COPD according to GOLD criteria and >10-pack year history of smoking, a post bronchodilator FEV1 < 90% of predicted and > 0.75 L, and post- bronchodilator FEV1/FVC < 70%
-No significant medical condition or concomitant medication that in the opinion of the investigator may compromise patient safety, patient compliance, interfere with evaluations, or preclude completion of the trial.
- Ability to perform standardize exercise protocol on cycle ergomter.
- Use of only short-acting inhaled beta2 agonists or short acting inhaled anti-cholinergics as needed to relieve COPD symptoms is permitted. Patients taking long-acting inhaled muscarinic antagonists may participate, if they are switched to short-acting inhaled beta2 agonists at least 48hours prior to study participation.
- Prior to administration of any study procedures, patients must provide written informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Treatments for COPD and allied conditions: The following medications (not listed here) should NOT be allowed unless they have been stabilized.
- Participation in any clinical investigation within 4 weeks prior to dosing or longer if required by local regulations.
- Donation or loss of 400ml or more of blood within 8 weeks prior to dosing.
- Significant illness within six weeks prior to dosing.
- Medical or family history of prolonged QT-interval syndrome, or prolonged QT-interval at screening.
- History of clinically significant drug allergy or history of atopic allergy. Known hypersensitivity to study drugs or drugs similar to study drug.
- History of immunodefiency diseases
- A positive Hepatitis B surface antigen or Hepatitis C test result.
- History of drug or alcohol abuse within the 12 months prior to dosing.
- Unable ischemic heart disease.
- History of myocardial infarction
- Angina related to exertion.
- Vulnerable individuals

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: - To determine the effect of exercice on maximal heart rate in patients with COPD following therapeutic doses of QAB149 and salmeterol<br>- To determine the effect of high-dose nebulized salbutamol on maximal heart rate in patients with COPD following therapeutic doses of QAB149 and salmeterol.;Secondary Objective: - To evaluate the cardiovascular safety (BP, HR and QTc) of therapeutic doses of QAB149 and salmeterol.<br>- To evaluate the effect of exercise on change in heart rate from pre-exercice in patients with COPD following therapeutic doses of QAB149 and salmeterol.<br>- To evaluate the non-cardiovascular safety and tolerability (blood glucose and serum potassium) of therapeutic doses of QAB149 and salmeterol.<br>- To evaluate the bronchodiltor efficacy of therapeutic doses of QAB149 and salmeterol.;Primary end point(s): Effect of exercise and high dose salbutamol on maximal heart rate

Secondary Outcome Measures

Name	Time	Method

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