E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Exercise-induced airway obstruction Asthma Allergic rhinitis |
Inspanningsastma Astma Allergische rhinitis |
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E.1.1.1 | Medical condition in easily understood language |
Asthma Allergic rhinitis |
Astma Allergische rhinitis |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
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 |
To analyze the protective effect of azelastine/fluticasone propionate against exercise-induced airway narrowing by measuring inspiratory and expiratory airflow limitation and airway resistance and reactance in asthmatic children. |
|
E.2.2 | Secondary objectives of the trial |
-Analyze the reduction in exercise-induced increase of airway resistance at low frequency, measured with FOT, after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo. -Analyze the reduction in exercise-induced decrease of airway reactance at low frequency, measured with FOT, after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo. -Analyze the increase in quality of life, measured with the pediatric asthma quality of life questionnaire (PAQLQ), after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo. -Analyze the increase in control of asthma, measured with the asthma control test (ACT), after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Clinical history of allergic rhinitis and EIB (exercise-induced bronchoconstriction) - Age between 12 and 18 years. - Ability to perform spirometry and FOT |
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E.4 | Principal exclusion criteria |
- Other pulmonary or cardiac illnesses - Severe EIB i.e. a fall of ≥40% FEV1 in the first ECT, requiring an acute change in maintenance medication (standard care) - Use of long acting bronchodilator agents 24 hours before testing - Use of short acting bronchodilator agents 8 hours before testing - Hospitalization due to asthma exacerbation in the last 4 weeks - Use of intranasal or systemic corticosteroids in the last 4 weeks prior to the study. - Use of antihistamines, cromoglycates, anticholinergics in two weeks prior the study or during the study. - Other changes in asthma medication during treatment period - Insufficient knowledge of the Dutch language |
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E.5 End points |
E.5.1 | Primary end point(s) |
-The reduction in exercise-induced fall in FEV1 after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo. -The reduction in exercise-induced fall in MIF50 after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo. |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
At day 1 and after 3 weeks |
|
E.5.2 | Secondary end point(s) |
-Analyze the reduction in exercise-induced increase of airway resistance at low frequency, measured with FOT, after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo. -Analyze the reduction in exercise-induced decrease of airway reactance at low frequency, measured with FOT, after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo. -Analyze the increase in quality of life, measured with the pediatric asthma quality of life questionnaire (PAQLQ), after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo. -Analyze the increase in control of asthma, measured with the asthma control test (ACT), after three weeks of treatment with azelastine/fluticasone propionate in comparison with a placebo |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
At day 1 and after 3 weeks |
|
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 | 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.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |