E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Exercise induced airway obstruction |
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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 | 10003557 |
E.1.2 | Term | Asthma exercise induced |
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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 | 10001723 |
E.1.2 | Term | Allergic rhinitis |
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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 |
Analyze the reduction in exercise induced fall of FEV1 and MIF50 after three weeks of treatment with fluticasone furoate.
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E.2.2 | Secondary objectives of the trial |
•Analyze the reduction in exercise induced increase of airway resistance, measured with the FOT, after three weeks of treatment with fluticasone furoate. •Analyze the reduction in exercise induced decrease of airway reactance, measured with the FOT, after three weeks of treatment with fluticasone furoate. •Analyze the reduction in FeNO, measured with the FOT, after three weeks of treatment with fluticasone furoate. •Analyze the increase in quality of life, measured with the PAQLQ, after three weeks of treatment with fluticasone furoate. •Analyze the increase in control of asthma, measured with the ACQ, after three weeks of treatment with fluticasone furoate.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Clinical history of allergic rhinitis and/or allergic asthma. - Age between 12 and 17 years. - Ability to perform reproducible lung function tests, i.e. coefficient of the predicted value variation in 3 of 5 consecutive measurements < 5%. - Maximal FEV1 greater than 70% of predicted value. - Clinically stable period at least 3 weeks before the study period.
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E.4 | Principal exclusion criteria |
- Use of intranasal or systemic corticosteroids in the last 4 weeks prior to the study. - Use of antihistamines, cromoglycates, anticholinergics in two weeks prior to the study. - Use of long acting bronchodilators 24 hours before testing. - Use of short acting bronchodilators 8 hours before testing. - Use of systemic corticosteroids, antihistamines, cromoglycates, anticholinergics, during the study. - Other pulmonary or cardiac disorder. - Deviation of the FEV1 of more than 12 % from baseline spirometry and the FEV1 before subsequent exercise provocation challenges. - Signs of gastro-esophageal reflux.
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E.5 End points |
E.5.1 | Primary end point(s) |
o Analyze the reduction in exercise induced fall of FEV1 after three weeks of treatment with fluticasone furoate. o Analyze the reduction in exercise induced fall of MIF50 after three weeks of treatment with fluticasone furoate.
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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 | 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 | 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 | 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
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | 0 |