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 | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10009026 |
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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 |
Evaluate the effects on exercise duration of 96 weeks treatment with 18 µg tiotropium (Spiriva HandiHaler) daily, in patients with COPD compared to placebo |
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E.2.2 | Secondary objectives of the trial |
The secondary objectives of the study will be evaluated by the followings end-points: -Exercise duration at Visit 11 -FEV1 and FVC measurements at each time point. -Questionnaires (Modified Borg scale, a Physician and patient global evaluation and St. Georges Hospital Respiratory Questionnaire (SGRQ)). -COPD exacerbations defined as -Exercise duration at Visits 4-9 |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
-Male or female -40 years old or more -with a diagnosis of COPD (pre-bronchodilator FEV1 60% or less then predicted, post bronchodilator FEV1 65% or less then predicted, FEV1/FVC less then 70%) -smoking history 10 or more pack-years |
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E.4 | Principal exclusion criteria |
-Patients with significant diseases other than COPD. A significant disease is defined as a disease or condition which, in the opinion of the investigator, may put the patient at risk because of participation in the study or may influence either the results of the study or the patients ability to participate in the study. -Patients with a history of asthma. -A history of thoracotomy with pulmonary resection. -Patients requiring the use of supplemental oxygen therapy. -Patients with any respiratory tract infection or COPD exacerbation in the 6 weeks prior to Visit 1 or during the washout period prior to Visit 3. These patients may be randomized 6 weeks following recovery from the infection or exacerbation -Patients with a recent history (i.e., 12 months or less) of myocardial infarction. -Patients with any unstable or life-threatening cardiac arrhythmia requiring intervention or change in drug therapy during the last year; or who have been hospitalized for cardiac failure during the past year. -Malignancy for which patient is undergoing radiation therapy or chemotherapy, within the last 5 years. -Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception. -A known hypersensitivity to anticholinergic drugs, lactose or any other component of the inhalation capsule, or to components in Atrovent or in the provided rescue medication. -Patients who are currently in a pulmonary or cardiac rehabilitation program or who have completed a pulmonary or cardiac rehabilitation program within 13 weeks of Visit 1. -Patients with a history of significant alcohol or drug abuse in the previous year. -Participation in another trial with an investigational drug within 30 days or 6 half lives (whichever is greater) of the start of the study. -Patients with a history of orthopaedic, muscular, neurological or cardiac disease that would interfere with regular participation in aerobic exercise or with exercise testing -Patients with prostatic hyperplasia or bladder neck obstruction. Patients with symptomatically controlled prostatic hyperplasia on medications may be included and should continue their medications -Patients with known narrow-angle glaucoma. -Patients with known moderate to severe renal impairment. -Patients with a body mass index < 18 kg/m**2 or > 35 kg/m**2. Patients who experience oxygen desaturation (oxygen saturation <=85%) during the incremental exercise test or during the constant work rate tests at Visit 3 and 3r. -History of life-threatening pulmonary obstruction, interstitial lung disease, cystic fibrosis, pulmonary thromboembolic disease or clinically evident bronchiectasis. |
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E.5 End points |
E.5.1 | Primary end point(s) |
The difference between treatment groups of the exercise duration during Constant Work Rate (CWR) treadmill exercise at 96 weeks |
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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 | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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.8.6 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 | Information not present in EudraCT |
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 | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |