E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009025 |
E.1.2 | Term | Chronic obstruct airways disease |
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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 demonstrate superiority of 150 μg o.d. of indacaterol versus tiotropium 18 μg o.d. with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment. Trough is defined as the mean of FEV1 measurements at 23h 10 min and 23h 45 min post morning dose. |
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E.2.2 | Secondary objectives of the trial |
To demonstrate that indacaterol 150 μg o.d, is non inferior to tiotropium 18 μg o.d. with regard to the rate of exacerbations during 52 weeks of treatment |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion criteria: Male and female adults aged &#8805;40 years, who have signed an Informed Consent form prior to initiation of any study-related procedure Co-operative outpatients with a diagnosis of severe COPD (severe as classified by the GOLD Guidelines, 2007 and including: a) Smoking history of at least 10 pack years b) Post-bronchodilator FEV1 <50% and &#8805;30% of the predicted normal value c) Post-bronchodilator FEV1/FVC <70% d) A documented history of at least 1 moderate or severe exacerbation in the previous 12 months. see Section 7.4.2 for the definition of a COPD exacerbation (Post refers to within 15 min of inhalation of 400 &#956;g (4x100&#956;g) of salbutamol, equivalent to 4 x 90 &#956;g albuterol delivered at the mouthpiece, at Visit 2). |
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E.4 | Principal exclusion criteria |
Exclusion criteria 1. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive serum human chorionic gonadotrophin laboratory test (>5 mIU/mL) 2. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, UNLESS they meet the following definition of postmenopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/mL or are using one or more of the following acceptable methods of contraception. a) surgical sterilization (e.g. bilateral tubal ligation, hysterectomy) b) hormonal contraception (implantable, patch, oral) c) double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap) Acceptable methods of contraception may include total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the patient ensures compliance. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception. Reliable contraception should be maintained throughout the study and for 30 days after study drug discontinuation 3. Patients whose body mass index is less than 15 or greater than 40 kg/m2 4. Patients requiring oxygen therapy for chronic hypoxemia (excluding acute COPD exacerbation). This is typically patients requiring oxygen therapy >15 h per day delivered by home oxygen cylinder or concentrator 5. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 2. Patients who develop a respiratory tract infection between Visit 2 and Visit 4 must discontinue from the trial, but may be permitted to re-enroll at a later date once the inclusion/exclusion criteria have been met 6. Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment and/or antibiotics in the 6 weeks prior to screening (Visit 2). In the event of an exacerbation occurring during the run-in period, the patient must discontinue from the study. The patient may re-enroll once the inclusion/exclusion criteria have been met 7. Patients with concomitant pulmonary disease, e.g., pulmonary tuberculosis (unless confirmed by chest x-ray to be no longer active) or clinically significant bronchiectasis 8. Patients with a history (at visit 1) of asthma, indicated by (but not limited to): a. Onset of respiratory symptoms suggestive of asthma (such as cough, wheezing, shortness of breath) prior to age 40 years PLEASE SEE PROTOCOL |
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E.5 End points |
E.5.1 | Primary end point(s) |
To demonstrate superiority of 150 &#956;g o.d. of indacaterol versus tiotropium 18 &#956;g o.d. with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment Trough is defined as the mean of FEV1 measurements at 23h 10 min and 23h 45 min post morning dose. |
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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 | 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 | No |
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) | Yes |
E.8.2.2 | Placebo | No |
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 | 32 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 204 |
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 | Yes |
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 | 2 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 4 |