E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10015649 |
E.1.2 | Term | Exercise induced asthma |
E.1.2 | System Organ Class | 100000004855 |
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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 |
To compare the effect of a single dose of montelukast and regular daily use of montelukast in children with exercise induced bronchoconstriction.
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E.2.2 | Secondary objectives of the trial |
To evaluate the onset and duration of protection against exercise induced bronchoconstriction after a single dose of montelukast. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Written informed consent from child and parent or guardian.
Age 10 - 14 years.
Proven exercise-induced asthma with a decrease in FEV1 of >12%.
Background medicine: inhaled corticosteroid therapy (equivalent to max 400-800mikg budesonide daily or equipotent doses).
FEV1 baseline ≥ 85% of predicted normal value.
Participants must be able to swallow a medicine capsule. |
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E.4 | Principal exclusion criteria |
Inability to use the study equipment correctly.
Treatment with long acting beta2-agonists.
Changing the background medication during the study period.
Short-acting beta2-agonists must not be used within 8 hours before the running test.
Antihistamines must not be used within 72 hours before the running test.
Hereditary galactose intolerance.
If the child is receiving regular montelukast, this treatment must be stopped within two weeks before the commencement of the trial.
Temperature above 38.5 or infection-related respiratory symptoms on days with scheduled running test. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To assess bronchoconstriction after the exercise challenge.
The maximum percentage decrease in FEV1 after exercise challenge.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The maximal postexercise fall in FEV1 is evaluated 2, 5, 8 and 11 hours after the last dose of montelukast/placebo. |
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E.5.2 | Secondary end point(s) |
To assess bronchoconstriction after the exercise challenge, the maximal percentage fall in FEV1 is measured.
Need for β-agonist rescue. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
The maximal postexercise fall in FEV1 is evaluated 2, 5, 8 and 11 hours after the last dose of montelukast/placebo.
Need for β-agonist rescue up to 90 minutes after exercise challenge test. |
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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 | Yes |
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 | Yes |
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 | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
Different dosage of the same product. Is a single dose as effective as regular daily use. |
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E.8.2.4 | Number of treatment arms in the trial | 6 |
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 | 3 |
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 | No |
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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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 | |
E.8.9.1 | In the Member State concerned days | |