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 | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10009033 |
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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 primary objective is to assess the efficacy of three dose levels (10 mg, 30 mg, and 50 mg) of SCH 527123 compared with placebo in subjects with moderate to severe chronic obstructive pulmonary disease (COPD), based on changes from Baseline in post-bronchodilator forced expiratory volume in one second (FEV1). |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to evaluate the safety and tolerability of SCH 527123 in subjects with COPD, as well as its effect on other lung function measures, exacerbations, symptoms, activity measures, health-related quality of life, and inflammatory markers. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. A subject must be >40 to <75 years of age, of either sex, and of any race. 2. A subject must have a diagnosis of COPD based on the American Thoracic Society/European Respiratory Society (ATS/ERS)/Global Initiative for Chronic Obstructive Lung Disease (GOLD) current guidelines, or have had symptoms consistent with COPD for more than 2 years prior to the baseline visit. 3. A subject must have clinically stable COPD, indicated by no exacerbation or change in COPD treatment within 6 weeks before Screening or between Screening and Randomization. 4. A subject must have a history for more than 3 months prior to Screening of sputum production most days of the week. 5. At Screening and at Baseline, in subjects at sites performing sputum induction, post-bronchodilator FEV1 must be greater than 1000 mL. 6. At Screening, a subjects post-bronchodilator FEV1 must be between 30% and 70% of the predicted value. 7. At Screening and Baseline, a subjects ratio of post-bronchodilator FEV1 to forced vital capacity (FVC) must be greater than 70%. 8. A subject must be either an ex-smoker with at least 6 months of smoking cessation, or a current smoker, and must have a smoking history of more than 10 pack-years (eg, 10 pack-year history is equal to smoking 1 pack of cigarettes per day for 10 years or 2 packs per day for 5 years). 9. If a subject had used inhaled corticosteroids (ICS) during the 6 weeks prior to Screening, the subject must have kept to a stable, low or medium daily dosage of ICS, alone or in combination with a long-acting beta-agonist (LABA) or a long-acting muscarinic antagonist (LAMA), within the 6 weeks prior to Screening and between Screening and Randomization, and must agree to continue at this dosage throughout the study unless directed by the investigator. 10. A female subject of child-bearing potential must agree to use a medically acceptable, highly effective method of birth control (ie, failure rate less then 1% per year when used consistently and correctly) prior to Screening, and agree to continue using it while in the study (Screening and Treatment periods) if she is heterosexually active. |
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E.4 | Principal exclusion criteria |
1. Subject who has been diagnosed with asthma or other clinically relevant lung disease (other than COPD) that, in the opinion of the investigator, precludes the subject from participating in the study (eg, sarcoidosis, tuberculosis, pulmonary fibrosis, severe bronchiectasis, or lung cancer). 2. Subject with clinically significant chest X-ray or computed tomography (CT) findings (eg, mass) inconsistent with stable COPD. 3. Subject who has undergone lobectomy, pneumonectomy, lung volume reduction (including bronchoscopic lung volume reduction) or any lung surgery other than biopsy. 4. Subject who has had a respiratory tract infection within 6 weeks prior to the Screening Visit. 5. Subject with acute, non-respiratory infection(s) at Screening should be excluded until resolution of the infection(s), as determined by the investigator. 6. Subject with >20% and &#61619;200 mL improvement at Screening in post bronchodilator FEV1. 7. Subject in need of supplemental oxygen therapy for >12 hours per day. 8. Subject who is breast-feeding, pregnant, or intends to become pregnant during the study. 9. Subjects who decide to discontinue smoking before Randomization are ineligible to participate. However, once enrolled, if a subject elects to discontinue smoking, or reduces cigarette consumption, he/she will be allowed to complete the study. 10. Subject who is using medication that may interfere with the effect of the study medication, or who has a clinically relevant medical condition that may interfere with the study procedures or evaluation, or any condition that is determined by the principal investigator to be significant. 11. Subject with a PBN count of <3 � 109/L at the Visit 1 (Screening Visit). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Mean change from Baseline in post-bronchodilator FEV1, the mean taken over the 26-week treatment period. |
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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 | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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.8.2.3.1 | Comparator description |
- same IMP used at different dosage |
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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 | 60 |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 4 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 4 |
E.8.9.2 | In all countries concerned by the trial days | 0 |