E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
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 | 10061877 |
E.1.2 | Term | Obstructive airways disorder |
|
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 demonstrate the superiority of indacaterol (300 µg o.d) in patients with moderate to severe COPD as compared to placebo with respect to exercise endurance time (measured through constant-load cycle ergometry testing) after 3 weeks of treatment. |
|
E.2.2 | Secondary objectives of the trial |
To evaluate the effect of indacaterol (300 µg o.d.) compared to placebo on trough Inspiratory Capacity (IC) after 3 weeks of treatment To evaluate the effect of indacaterol (300 µg o.d.) compared to placebo on trough FEV1 after 3 weeks of treatment To evaluate the effects of indacaterol (300 µg o.d.) compared to placebo on pulmonary function tests after 3 weeks of treatment whilst: 1. The patient is not exercising (i.e. patient is at rest) 2. The patient is exercising To evaluate the effect of indacaterol (300 µg o.d.) compared to placebo on exertional dyspnea (Borg CR10 Scale) during exercise after 3 weeks treatment To evaluate the effect of indacaterol (300 µg o.d.) compared to placebo on leg discomfort (Borg CR10 Scale) during exercise after 3 weeks treatment To assess the effect of indacaterol (300 µg o.d.) on patient activity measured using an actigraphy device, as compared with placebo after 3 weeks treatment |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male and female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure 2. Co-operative outpatients with a diagnosis of COPD (moderate to severe as classified by the GOLD Guidelines, 2006) and: 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% (Post refers to within 15 to 30 min of inhalation of 400 µg of salbutamol - equivalent to 4 x 90 µg albuterol delivered at the mouthpiece at Visit 2) |
|
E.4 | Principal exclusion criteria |
Pregnant or nursing (lactating)women Women of child-bearing potential,unless they are using an acceptable methods of contraception. Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 2 or during the run-in period Patients requiring oxygen therapy or who experience oxygen desaturation to <80% during cycle exercise on room air Patients with a Wmax value < 20 W (as determined by the incremental cycle endurance test) at Visit 2 Patients who have had a respiratory tract infection within 6 weeks prior to Visit Patients who develop a respiratory tract infection prior to randomization must discontinue from the trial, but may be permitted to re-enroll at a later date (at least 6 weeks after the start of the respiratory tract infection) Patients with contra-indications of cardiopulmonary exercise testing s.p.pag.17) Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis 9. Patients with a history (up to and including Visit 2) of asthma indicated by (but not limited to): blood eosinophil count > 400/mm3 onset of respiratory symptoms prior to age 40 years. Patients with Type I diabetes. Patients with uncontrolled Type II diabetes signified by HbA1C > 8.0% of total Hb measured at Visit 2 11. Patients who, in the judgment of the investigator, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) unstable ischemic heart disease, arrhythmia (excluding stable AF), uncontrolled hypertension, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state or any condition which in the investigators opinion might compromise patient safety or compliance, interfere with evaluation, or preclude completion of the study 12. Any patient with lung cancer or a history of lung cancer 13. Any patient with active cancer or a history of cancer with less than 5 years disease free survival time (whether or not there is evidence of local recurrence or metastases). Localized basal cell carcinoma (without metastases) of the skin is acceptable. Patients with a history of cancer (excluding lung cancer) and 5 years or more disease free survival time may be included in the study at the investigators discretion on a case-by-case basis 14. Patients with a history of long QT syndrome or whose QTc interval (Bazetts) measured at Visit 2 or Visit 4 is prolonged: > 450 ms (males) or > 470 ms (females) as assessed by the investigator. Patients who fail the screening ECG (with the exception of machine failures) should not be re-screened. 15. Patients with a history of hypersensitivity to any of the study drugs or to drugs with similar chemical structures including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof 16. Patients who do not maintain regular day/night, waking/sleeping cycles (e.g., night shift workers) 17. Patients who have had treatment with investigational drugs at the time of enrollment, or within 30 days or 5 half-lives prior to Visit 2, whichever is longer. 18. Patients who have had live attenuated vaccinations within 30 days prior to Visit 2 or during the run-in period. (inactivated Influenza vaccination, pneumococcal vaccination or any other inactivated vaccine is acceptable provided it is not administered within 48 h prior to study visits) Patients with Type I diabetes. Patients with uncontrolled Type II diabetes signified by HbA1C > 8.0% of total Hb measured at Visit 2 11. Patients who, in the judgment of the investigator, have a clinically relevant laboratory abnormality or a clinically significant condition such as (but not limited to) unstable ischemic heart disease, arrhythmia (excluding stable AF), uncontrolled hypertension, uncontrolled hypo- and hyperthyroidism, hypokalemia, hyperadrenergic state. (see p.18-19). |
|
E.5 End points |
E.5.1 | Primary end point(s) |
To demonstrate the superiority of indacaterol (300 µg o.d) in patients with moderate to severe COPD |
|
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 | No |
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 | 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 | 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) | 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.8.4.1 | Number of sites anticipated in Member State concerned | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
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 |
|
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
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |