E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
COPD (chronic Obstructive Pulmonary Disease) |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010952 |
E.1.2 | Term | COPD |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
- To determine the effect of exercice on maximal heart rate in patients with COPD following therapeutic doses of QAB149 and salmeterol - To determine the effect of high-dose nebulized salbutamol on maximal heart rate in patients with COPD following therapeutic doses of QAB149 and salmeterol. |
|
E.2.2 | Secondary objectives of the trial |
- To evaluate the cardiovascular safety (BP, HR and QTc) of therapeutic doses of QAB149 and salmeterol. - 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. - To evaluate the non-cardiovascular safety and tolerability (blood glucose and serum potassium) of therapeutic doses of QAB149 and salmeterol. - To evaluate the bronchodiltor efficacy of therapeutic doses of QAB149 and salmeterol. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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 |
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E.5 End points |
E.5.1 | Primary end point(s) |
Effect of exercise and high dose salbutamol on maximal heart rate |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 3 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
Last visit (Study completion) of last subject enrolled in trial |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 6 |