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 | 13.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010952 |
E.1.2 | Term | COPD |
E.1.2 | System Organ Class | 10038738 - Respiratory, thoracic and mediastinal disorders |
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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 evaluate the effect of ASA as add-on therapy in COPD patients in comparison to placebo in spirometric and clinical regard, and to evaluate safety of this therapy. |
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E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Signed informed consent prior to any study-mandated procedure. • Male and female patients aged ≥ 18 and ≤ 75 yrs. • Clinically and functionally proven COPD GOLD II-III (definition: COPD with postbronchodilatator FEV1/FVC: < 0.7; FEV1: < 80%, but ≥30% predicted; improvement of FEV1 after bronchodilatator ≤ 12% AND ≤ 200ml) • AST and ALT values within three times upper limit of normal. • Serum creatinine ≤ 1.5 mg/dl. • Ability to communicate well with the investigator, in the local language, and to understand and comply with the requirements of the study. • Negative pregnancy test in female patients of childbearing potential. • Adequate contraception in female patients of childbearing age. • Absence of acute bronchitis, active COPD exacerbation or relevant acute infection within 7 days before active study participation (start of PEF-baseline) • Smoker or ex-smoker (minimum history of ≥ 5 pack years)
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E.4 | Principal exclusion criteria |
• Known hypersensitivity to ASA. • Treatment with another investigational drug within 1 month prior to start of study medication. Other known severe cause of pulmonary disease like known active tuberculosis, systemic fungal infection, lymphoma, asthma, interstitial lung disease, significant pulmonary hypertension. • Long term (> 2 months) administration of ASA or other NSAIDs within the past 2 years. This in-cludes low-dose ASA for prophylactic reasons. (Allowed: Clopidogrel intake) • Patients requiring therapeutic anticoagulation • Malignancy requiring chemotherapy or radiation • Uncontrolled other known disease like: • Chronic heart failure NYHA III, IV • Uncontrolled diabetes mellitus with a blood glucose 2x per day > 250 mg/dl (in the past week), or a HbA1c > 10 % • Gastrointestinal ulcera or history of relevant gastrointestinal bleedings • Severe renal or hepatic insufficiency • Uncontrolled arterial hypertension (SBP > 180 mmHg) • Current acute bronchitis, COPD exacerbation or relevant infection • Are pregnant, nursing, or planning pregnancy during the trial or within three month period thereafter • Have a known drug or alcohol abuse within 3 years of screening • Presumed non-compliance. • Known legal incapacity or limited legal capacity at screening • Relevant coagulation disorders • Planned relevant surgical interventions during study period • Smoking history of less than 5 pack years during lifetime
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E.5 End points |
E.5.1 | Primary end point(s) |
Changes (δ) in FEV1 after 12 weeks of study medication compared to baseline. Post-bronchodilatator FEV1 will be measured between 0 and 8 hours after last dose of study medication. FEV1 will be measured always in the morning between 08:00 and 10:30 a.m. |
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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 | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | Yes |
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) | 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.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
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 | 1 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |