Chronic obstructive pulmonary disease MedDRA version: 8.1 Level: LLT Classification code 10009033 Term: Chronic obstructive pulmonary disease
Conditions
Interventions
Product Name: indacaterol
Product Code: QAB149
Pharmaceutical Form: Inhalation powder, hard capsule
Current Sponsor code: QAB149 Drug substance
Concentration unit: µg microgram(s)
Concentration type:
Sponsors
NovartisPharma Services AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male and female adults aged 40-75 years inclusive, who have signed an Informed Consent Form prior to initiation of any study-related procedure (which includes any adjustment to their current COPD treatment). Patients with a clinical diagnosis of COPD according to the GOLD Guidelines (updated July 2005) and a history of characteristic COPD symptoms (such as cough, sputum production, dyspnea), who additionally meet the following criteria: a) Smoking history of at least 10 pack years. (1 pack year is defined as 20 cigarettes per day, every day, for one year, or 10 cigarettes a day for two years, or 40 cigarettes a day for six months etc.). b) FEV1 at Visit 1 and Visit 2 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Hospitalization for an exacerbation of COPD, or a respiratory tract infection, in the 6 weeks prior to screening; history of asthma (or history of childhood asthma) or concomitant pulmonary disease; clinically relevant laboratory abnormality or a clinically significant condition; pregnant or nursing (lactating) women, or women of child-bearing potential; long-term oxygen therapy; patients unable to use dry powder inhaler devices or perform spirometry. Treatment for COPD and allied conditions within a specified period prior to screening (or during the study): tiotropium (7 days), long-acting ß2-agonists (48 h), fixed combinations of b2-agonists and inhaled corticosteroids (48 h), theophylline and other Xanthines (1 week), parenteral or oral corticosteroids (1 month). Treatment for COPD and allied conditions for at least the minimum washout period specified, or during the study unless they have been stabilized at least one month prior to start of the study: short-acting ß2-agonists other than albuterol/salbutamol rescue medication (6 h), short-acting anti-cholinergics (8 h), fixed combinations of short-acting ß2-agonists and short-acting anti-cholinergics (8 h). Patients receiving treatment with the following medications unless they have been stabilized at least one month prior to screening: inhaled or nasal corticosteroids, cromoglycate, nedocromil, ketotifen and leukotriene antagonists, some antihistamines (unless they have been stabilized at least 5 days prior to screening). Patients receiving treatment with with non-potassium sparing diuretics, non-selective beta-blocking agents, cardiac anti-arrhythmics Class Ia or Class III, terfenadine, astemizole, mizolastin and any drug with potential to significantly prolong the QT interval, tricyclic antidepressants and monoamino-oxidase inhibitors, antibiotics (if prescribed for a respiratory tract infection).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the bronchodilatory efficacy of single doses of indacaterol 150 µg, 300 µg & 600 µg via SDDPI in patients with moderate to severe COPD as compared to placebo in terms of 24 h post-dose (trough) FEV1.;Secondary Objective: To assess the safety of single doses of indacaterol 150 µg, 300 µg & 600 µg via SDDPI compared to placebo in patients with COPD in terms of adverse events, laboratory analysis, vital signs (blood pressure and pulse rate) and ECGs. To evaluate the bronchodilatory efficacy measures of single doses of indacaterol 150 µg, 300 µg and 600 µg via SDDPI compared to placebo in terms of: Time to peak FEV1 Percent change in FEV1 compared to baseline at each time point post-dose FEV1 and FVC at each time point post-dose Standardized FEV1 AUC between baseline (pre dose) and 4 h post-dose ;Primary end point(s): 24 hour post-dose (trough) FEV1 | — |
Countries
Belgium
Outcome results
None listed