E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Bronchial Asthma exercize inducted |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10003553 |
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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 determine the effect of 4 weeks of treatment with oral montelukast plus inhaled fluticasone, and inhaled salmeterol plus inhaled fluticasone on exercise induced bronchoconstriction EIB as measured by the maximum post exercise percent fall relative to pre-exercise baseline in FEV1. |
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E.2.2 | Secondary objectives of the trial |
To determine the effect of a 4-week treatment course of montelukast, compared to salmeterol, on the 1 extent and severity of EIB as measured by the AUC0-20, 2 short acting 61538;-agonist bronchodilation as measured by the average percent fall in FEV1 after exercise, 3 additive effect of 61538;2 adrenergic agonism as measured by the time to recovery following 61538;-agonist intake, and 4 extent and severity of EIB as measured by the average percent change in FEV1 after first 61538;-agonist intake. To determine the safety and tolerability of daily treatment with montelukast vs salmeterol in children, aged 6 to 14 years. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
Patient and/or patient caretaker understand the study procedures and agree to participate by signing the appropriate informed consent form. b. Patient is a male or female at least 6 and no more than 14 years of age at Visit 1. c. Patient has been a regular user of inhaled corticosteroids ICS at doses stable for at least 8 weeks before Visit 1 d. Patient fulfills ALL of the following signs and symptoms of asthma by Visit 1 1 A consistent clinical history of asthma for at least 1 year of intermittent or persistent symptoms including but not limited to dyspnea, wheezing, chest tightness, cough, or sputum production. 2 A forced expiratory volume in one second FEV1 , while withholding 61538;-agonist for at least 6 hours, of 8805;70 of the predicted value. Exercise-induced bronchoconstriction showing a decrease in FEV1 of 8805; 20 while on inhaled corticosteroids is to be performed twice in the run in period at visits 1, 2, and/or 3 e. Patient is currently a non-smoker. f. Patient is able to perform exercise on a treadmill. g. Patient is judged to be in good, stable, physical, and mental health except for asthma on the basis of medical history, physical examination, and routine laboratory data, and appears able to successfully complete this trial. |
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E.4 | Principal exclusion criteria |
General a. Consent cannot be obtained from parent or guardian. b. Patient is, in the opinion of the investigator, mentally or legally incapacitated preventing informed consent from being obtained. c. Patient is hospitalized. d. Patient has undergone any major surgical procedure within 4 weeks of Visit 1. e. Patient has participated in a clinical trial involving an investigational or marketed drug within 4 weeks of Visit 1. Pulmonary f. In addition to asthma, patient has any active, acute, or chronic pulmonary disorder documented by history, physical exam, or chest x-ray historical . g. Patient has unresolved signs and symptoms of an upper respiratory tract infection URI within 1 week of Visit 1. h. Patient has evidence of active, clinically significant sinus infection if previously present, it must have resolved within seven days of Visit 1 . i. Patient has ever been intubated for asthma, has required acute asthma therapy treated in an emergency room/urgent care facility/office setting within one month or has been hospitalized for asthma within three months of Visit 1. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To determine the effect of 4 weeks of treatment with oral montelukast plus inhaled fluticasone, and inhaled salmeterol plus inhaled fluticasone on exercise induced bronchoconstriction EIB as measured by the maximum post exercise percent fall relative to pre-exercise baseline in FEV1. |
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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 | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | Information not present in EudraCT |
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 | Information not present in EudraCT |
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 | Yes |
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) | 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
| 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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 1 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |