E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
chronic obstructive pulmonary disease |
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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 |
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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 confirm indacaterol (150 μg o.d.) superiority in patients with COPD as compared to placebo with respect to 24 h post dose trough FEV1 after 12 weeks of treatment. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the effect of indacaterol on the percentage of “days of poor control”. To evaluate the effect of indacaterol health related quality of life assessments To evaluate the effect of indacaterol on exacerbation To evaluate the effect of indacaterol on the TDI focal score To compare indacaterol to placebo spirometry assessments in terms of trough FEV1 , FEV1, FVC, peak response, trough response, standardized AUC for FEV1 (5 min – 1h, 5 min – 4h for a sub group) To evaluate the effect of indacaterol (150 μg o.d.) and placebo on other clinical variables such as morning (pre-medication) and evening (pre-medication) PEF, clinical symptoms and use of rescue medication over 26 weeks. To evaluate the effect of indacaterol on post inhalation events (especially cough) as compared to placebo measured over 26 weeks of treatment. To assess the long term safety of indacaterol. |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Pharmacogenetic sub-study for a 26-week treatment, multicenter, randomized, double blind, double dummy, placebo controlled, parallel group study to assess the efficacy, safety and tolerability of indacaterol (150 μg o.d.) in patients with chronic obstructive pulmonary disease, using salmeterol 50 μg bid) as an active control. release date of the sub-study : 10 May 2007 |
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E.3 | Principal inclusion criteria |
Male and female adults aged ≥ 40 years, who have signed an Informed Consent . Co-operative outpatients with a diagnosis of COPD (moderate to severe as classified by the GOLD Guidelines, 2006) and including: a) Smoking history of at least 20 pack years b) Post-bronchodilator FEV1 < 80% and ≥30% of the predicted normal value. c) Post-bronchodilator FEV1/FVC < 70%
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E.4 | Principal exclusion criteria |
Pregnant or nursing (lactating) women, or women of child-bearing potential UNLESS post-menopausal or using acceptable methods of contraception. Patients who have had a respiratory tract infection, or hospitalization for a COPD exacerbation, in the 6 weeks prior to Visit 1 or during the run-in period. Patients requiring oxygen therapy for chronic hypoxemia (>15 h per day delivered by home oxygen cylinder or concentrator). Patients with concomitant pulmonary disease, pulmonary tuberculosis or clinically significant bronchiectasis. Patients with a history (up to and including Visit 1) of asthma indicated by (but not limited to): blood eosinophil count > 400/mm3 or onset of respiratory symptoms prior to age 40 years. Patients with diabetes Type I or uncontrolled diabetes Type II. Patients who have a clinically relevant laboratory abnormality or a clinically significant condition, or any condition which in the investigator’s opinion might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study Any patient with lung cancer or a history of lung cancer; or any patient with active cancer or a history of cancer with less than 5 years disease free survival time on a case-by-case basis. Patients with a history (or family history) of long QT syndrome or whose QTc interval (Bazett’s) measured at Visit 1 or Visit 3 is prolonged: > 450 ms (males) or > 470 ms (females). Patients who do not maintain regular day/night, waking/sleeping cycles. Patients who have had treatment with investigational drugs at the time of enrollment, or within 30 days or 5 half-lives prior to Visit 1, whichever is longer. Some treatments for COPD and allied conditions, or some non-COPD medications, within at the minimum washout period specified or at any time during the study. (See other criteria in the protocol pages 14 to 17). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Superiority of Indacaterol as compared to placebo with respect to 24h post dose trough FEV1 after 12 weeks treatment. |
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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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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 | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 5 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 72 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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
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Last visit of the last subject undergoing the trial. |
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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 | 8 |
E.8.9.1 | In the Member State concerned days | 15 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 1 |