E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Anticholinergic bronchodilators, such as ipratropium bromide, may be used in combination with beta adrenergic agonists as SAlbutamol to produce bronchodilation in excess of that achieved by either agent alone.Therefore we will treat both study arms with salbutamol. One group A will receive tiotropium bromide with salbutamol, while the other group B will receive salbutamol.
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 8.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10010952 |
E.1.2 | Term | COPD |
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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 |
is to detect differences in the relative mucin amount between patients with acute exacerbation of COPD treated with tiotropium bromide (Spiriva ®) plus salbutamol and those treated with salbutamol alone. |
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E.2.2 | Secondary objectives of the trial |
is to investigate the improvement of both the biophysical and transport properties of sputum in patients with acute exacerbation of COPD and the reduction of airway obstruction in the treatment groups.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• provided written informed consent • Hospitalized male or female subjects’ ≥ 35 years of age. • Subject who has COPD 2 or 3 according to the GOLD criteria (see Table 1) • FEV1/FVC < 70% • 30% <= FEV1 (GOLD 3) < 50% <= FEV1 (GOLD 2) < 80% predicted • with chronic symptoms (cough, sputum production) • Subjects must have a clinical diagnosis of an acute exacerbation of an underlying COPD (GOLD 2 and 3) supported by at least two of the following signs and symptoms: increased sputum purulence, increased dyspnea, or increased sputum volume (Anthonisen Criteria I or II). • The onset of signs and symptoms of the current exacerbation must occur within 7 days before start of evaluation. • Subjects may have taken inhaled anticholinergic- or β2-agonists drugs prior to the study, except tiotropium bromide. • Subjects may have taken inhaled corticosteroids (ICS) prior to the study.
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E.4 | Principal exclusion criteria |
• • Subjects who have taken tiotropium bromide in the last 4 weeks. • Subjects should not have received any mucolytic drug such as acetylcysteine or ambroxol during the study and 24 hours prior to the study. • Subjects who inhale corticosteroids during the time of study; whereas on the day and the day after evaluation inhaled corticosteroids are accepted. • Subject who has suspected or known (positive chest radiograph) pneumonia. • Subject who has suspected or known asthma bronchiale. • Subject who requires parenteral antibiotic therapy. • Subject who has taken: o A systemic antibiotic within 2 weeks before study drug administration o Any long acting antibiotic (e.g., penicillin G benzathine or azithromycin) within 4 weeks before study drug administration. • Subject who has any other infection or condition, which necessitates use of a concomitant systemic antibiotic. • Subject who has a severely compromised respiratory status (i.e., requires continuous oxygen). • Pregnant or breast feeding women • Subjects who are participating in any other clinical study
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint of the study is the MUC5AC response. Patients will be considered as responders if their relative amount of MUC5AC, at 42 days after randomization, is equal to the laboratory standard level, a tolerance of +/-15% is permissible. |
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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 | 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 | Yes |
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
| 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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The end of study is if the last patient has been completed the last visit |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |