COPD (chronic Obstructive Pulmonary Disease) MedDRA version: 9.1 Level: LLT Classification code 10010952 Term: COPD
Conditions
Interventions
Product Name: Indacaterol
Product Code: QAB149
Pharmaceutical Form: Inhalation powder, hard capsule
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 300-
Pharmaceuti
Sponsors
Novartis Pharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
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 0.75 L, and post- bronchodilator FEV1/FVC =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - 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.;Secondary Objective: - 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.;Primary end point(s): Effect of exercise and high dose salbutamol on maximal heart rate | — |
Countries
Belgium, Germany, Italy
Outcome results
None listed