E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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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 |
Main objective : - To compare the clinical efficacy of intravenous (IV) montelukast 7 mg, compared with placebo, when administered as adjunctive therapy to adult patients with acute asthma on the primary endpoint (improvement in forced expiratory volume in 1 second [FEV1] within the first 60 minutes after administration), the key secondary endpoint (incidence of treatment failures), and the other secondary endpoint (amount of additional therapy [short-acting beta-agonist] required). |
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E.2.2 | Secondary objectives of the trial |
Secondary objectives : - To estimate the onset of action (rate of FEV1 improvement) of montelukast IV, compared with placebo, when administered as adjunctive therapy in adult patients with acute asthma. - To determine the safety and tolerability of montelukast IV when administered for the treatment of acute asthma.
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patient is a male or female at least 18 years of age. Patient is admitted to the study site because of an acute exacerbation of asthma and has at least a 1 year (can be verbal information from the patient) history of asthma. During Period I, patient has a forced expiratory volume in 1 second (FEV1) of less than or equal to 50% of the predicted value on all measurements.
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E.4 | Principal exclusion criteria |
Based upon history or physical examination at the study site, the patient has any known or suspected, acute or chronic cause for their pulmonary symptoms other than asthma (e.g., congestive heart failure, etc.). As assessed in the study site, the patient’s asthma has life-threatening features, including, but not limited to, immediate respiratory failure, the need for intubation, evidence of a pneumothorax, or pneumomediastinum. The time between when the patient begins receiving treatment for acute asthma at the study site and study drug administration exceeds 60 minutes. Patient has received parenteral corticosteroids (any dose) or oral corticosteroids (in excess of their usual dose) within 12 hours of study site admission or during the preallocation period (Period I). (All allocated patients will receive systemic [oral] corticosteroids at the time of randomization.) Patient has begun an oral leukotriene receptor antagonist or a leukotriene synthesis inhibitor (marketed or investigational) within 2 weeks of study site admission or the patient is on chronic stable doses of anti-leukotriene agents, but the last dose was taken in the 12 hours prior to study site admission or during the preallocation period (Period I). Patient has received any anti-asthma therapies other than oxygen, beta-agonists, anticholinergics, or corticosteroids during Period I.
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E.5 End points |
E.5.1 | Primary end point(s) |
The time weighted average change in FEV1 from preallocation baseline over the first 60 minutes after study drug administration [average change in FEV1 (0-60 min)] |
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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 | 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 | 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) | Information not present in EudraCT |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
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
| 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 | 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 | 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 | |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 12 |