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 |
The principal objective of this research is to determine whether intermittent parent-initiated treatment with oral montelukast in preschool children with a history of wheeze, reduces the need for unscheduled medical attention for wheeze. To assess this treatment will be started by parents or guardians i) at the onset of every cold and continued for a minimum of 7 days or until wheeze has resolved for 48 hours, and ii) for every episode of wheeze not associated with a viral cold, and stopped when symptoms have resolved for 48 hours. For each child, the trial will last 12 months. |
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E.2.2 | Secondary objectives of the trial |
Respiratory morbidity
• Number of days with parent-reported wheeze over the 12 month trial period • Number of admissions to hospital over the 12 month trial period • Duration of admissions to hospital over the 12 month trial period • Time to first attack of wheeze • Number of unscheduled GP consultations for wheeze • Duration of episodes by diary card • Severity of episodes by diary card • Parent’s overall impression of efficacy of IMP (trial medication)
Health service use
• Unscheduled GP consultation with exacerbation of wheeze, expressed as time from randomisation to first attendance and annual attendance rate • A&E attendance with wheeze exacerbation, expressed as time from randomisation to first attendance and annual attendance rate • Unscheduled hospital admission with wheeze exacerbation, expressed as time from randomisation to first admission and annual rate of admissions • Total duration of hospital admissions for exacerbation of wheeze
Adverse events
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• age ≥ 10 months and ≤ 5 years on the day of the first dose of IMP. • two or more attacks of parent-reported wheeze, • at least one attack with wheeze validated by a clinician • the most recent attack within the last 3 months. • contactable by telephone and able to attend one face-to-face review for issue of IMP • parent or guardian able to give written informed consent for their child participate in the study.
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E.4 | Principal exclusion criteria |
•• any other chronic respiratory condition diagnosed by a clinician including structural airway abnormality (e.g. floppy larynx) and cystic fibrosis • any chronic condition that increases vulnerability to respiratory tract infection such as severe developmental delay with feeding difficulty • history of neonatal chronic lung disease • current continuous oral montelukast therapy • in a trial using an IMP within the previous 3 months prior to recruitment.
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measures for this trial is; • Number of times a child attends for an unscheduled medical opinion with wheeze over the 12 month trial period |
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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 | Yes |
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) | 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.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
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 | Yes |
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 the trial will be considered as the date of the final database lock. However, the trial may be closed prematurely by the Trial Steering Committee, on the recommendation of the Independent Data and Safety Monitoring Committee. |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
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 |
E.8.9.2 | In all countries concerned by the trial days | 0 |