E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic Obstructive Pulmonary Disease |
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MedDRA Classification |
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 of this study is to assess the effect of a single dose of salbutamol in comparison with ipratropium bromide on central and peripheral small airways with high-resolution/multislice CT scan imaging technique.
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E.2.2 | Secondary objectives of the trial |
The secondary objectives are to evaluate effects on spirometric indices (as Forced Expiratory Volume in one second (FEV1) and Tiffeneau index), to correlate these with the CFD based calculated airway volumes and resistances for both compounds and to evaluate the safety of the products.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1.Patients with documented COPD based on the following criteria: • Smoking history of at least 10 pack-years. • Decreased Tiffeneau index (FEV1/(F)VC < 0.70). 2.Patients aged ≥ 40 years. 3.Patients should present moderate to severe COPD with an FEV1 between 30 and 80% of predicted (GOLD 2 and 3). 4.Patients should be treated according to GOLD guidelines. 5.Able to inhale study drug. 6.Maintained on stable respiratory medications for 6 weeks prior to visit 1. 7.Able to perform lung function tests. 8.Able to follow study procedures.
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E.4 | Principal exclusion criteria |
1.Patients who are allergic to salbutamol, ipratropium bromide or to another element of the product. 2.Patients allergic to sojalecithin and products on the basis of soja and peanut. 3.Patients who have or ever had glaucoma. 4.Patients with urinary problems, prostate hyperplasy or bladder-neck obstruction. Patients whose symptoms are controlled on treatment may be included. 5.Patients with a recent history (i.e. six months or less) of myocardial infarction. 6.Patients with any unstable or life threatening cardiac arrhythmia. 7.Patients with severe kidney insufficiency (creatinine clearance ≤50 ml/min)a. 8.Patients below the age of 40. 9.Patients who are pregnant or are breast-feeding. 10.Patients who are treated with other anticholinergic medications, that cannot be stopped during the study period. 11.A respiratory infection or exacerbation of COPD in the four weeks prior to screening. 12.Significant alcohol or drug abuse within the past 12 months. 13.Participation in another trial with an investigational drug within one month or six half lives (whichever is greater) prior to screening visit. 14.Known active tuberculosis. 15.A history of asthma, cystic fibrosis, central bronchiectasis, interstitial lung disease or pulmonary thromboembolic disease. 16.A history of thoracotomy with pulmonary resection. 17.Active or untreated malignancy. 18.Use of oral corticosteroid medication at unstable doses (i.e. less than six weeks on a stable dose) or at doses ≥ 10 mg/day.
a Cockroft’s formulae should be applied: in male: creatinine clearance = (140-age) x weight / 72 x creatininemia in female: creatinine clearance = 0.85 x (140-age) x weight / 72 x creatininemia
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E.5 End points |
E.5.1 | Primary end point(s) |
Effect of delivery treatment |
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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 | 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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | Yes |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.5 | 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 | |
E.8.9.1 | In the Member State concerned days | |