E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Obstructive Pulmonary Disease (COPD) |
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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 |
The main purpose of this extension is to provide data on the long-term (52 week) safety of indacaterol doses (150 and 300 µg o.d. via SDDPI) in patients with moderate to severe COPD.
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E.2.2 | Secondary objectives of the trial |
To evaluate the efficacy of indacaterol (150 and 300 µg o.d) versus placebo on the percentage of ‘days of poor control’ reported over 52 weeks. To evaluate the effect of indacaterol (150 and 300µg o.d) versus placebo on time to first COPD exacerbation and on the COPD exacerbation rate, over 52 weeks. To evaluate the effect of indacaterol (150 and 300µg o.d) versus placebo on the total score of the St Georges Respiratory Questionnaire (SGRQ) after 36, 44 and 52 weeks. To evaluate the effect of indacaterol (150, and 300 µg o.d) versus placebo on report of post inhalation events (especially cough), over 52 weeks. To evaluate the efficacy of indacaterol (150 and 300 µg o.d) versus placebo on early response with respect to FEV1 and FVC at all time points over 52 weeks treatment.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Details of inclusion criteria for the core study B2335S can be found in the core study protocol. Patients eligible to participate in the study extension, by definition, will have met the inclusion criteria for the core 26 weeks and not met the withdrawal criteria for the core study B2335S at Visit 14 (the last visit of the core study B2335S and the first visit of the extension study B2335SE).
In addition the following inclusion criteria specified below must be met.
1. Patients must complete Stage 2 of the core study B2335S. 2. Written informed consent to participate in the extension must be obtained. 3. Patients must be able to comply with all study requirements.
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E.4 | Principal exclusion criteria |
Details of exclusion criteria for the core study B2335S can be found in the core study protocol.
In addition the following exclusion criteria specified below must be met.
1. Patients who were randomized to open-label tiotropium in Study B2335S. 2. Patients who participated in Stage 1 of the core study (B2335S). 3. Patients discontinued irrespective of the reason from Stage 2 of the core study. 4. Patients who fail to comply with the core protocol requirements and procedures. 5. Concomitant medical conditions that may interfere with interpretation of study results as defined in the core study protocol. 6. Patients who in the Investigator’s opinion should not-participate in the extension study.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary objective of this study is to evaluate the safety of indacaterol (150 µg and 300 µg o.d. via SDDPI) in patients with moderate to severe COPD following 52 weeks treatment. The assessment of safety will include all safety measurements including adverse events and COPD exacerbations, however, particular attention will be paid to the key safety variables for this class of drug namely, serum potassium and glucose, heart rate, blood pressure, and QTc. |
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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 | Yes |
E.6.7 | Pharmacodynamic | No |
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 | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
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 | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
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.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 4 |
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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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 | 26 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 26 |