E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
|
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10003553 |
E.1.2 | Term | Asthma |
|
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 determine whether Montelukast has a therapeutic role in the treatment of acute asthma |
|
E.2.2 | Secondary objectives of the trial |
We will look at the impact of montelukast on reliever inhaler use over the following week. We will look at how the addition of montelukast affects symptom scores over the week following an exacerbation compared to placebo. We will look at how the addition of montelukast affects peak flow readings over the week following an exacerbation. We will look at how the addition of montelukast affects the FEV1 and FEF25-75 at 48hours and 1 week. We will look at its impact on measures of airway resistance and reactance at 48hours and 1 week. We will look at nitric oxide levels and how these differ between the montelukast and placebo groups. We will look at how peripheral eosinophil count varies between the groups over the course of a week. We will see if there is any difference in duration of inpatient stay between the groups. Another aim is to determine whether particular genetic subgroups derive more benefit than others when treated with Montelukast. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Acute asthma with peak flow of less than 75% predicted Age 18 tom 65 Willingness to use effective contraception Written informed consent |
|
E.4 | Principal exclusion criteria |
Known or suspected hypersensitivity to Montelukast Known or suspected pregnancy Lactation Use of a LRA within the 2 weeks prior to presentation Any other significant concomitant respiratory disease Any clinically significant disease that may, in the opinion of the investigators, affect evaluation of the study Fever greater than 38C |
|
E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint will be change in Peak Expiratory Flow at 3 hours and 2 days |
|
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 | No |
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 | Yes |
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 | 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.8.5 | 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
|
The last visit of the last enrolled subject will constitute the end of the trial |
|
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 | |
E.8.9.2 | In all countries concerned by the trial years | 1 |