E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Exercise induced bronchoconstriction |
Inspannings geinduceerde bronchoconstrictie |
|
E.1.1.1 | Medical condition in easily understood language |
Excercise asthma |
Inspanningsastma |
|
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 |
Main objective of this study is to investigate if salbutamol protects against inspiratory airflow obstruction. |
Doel van deze studie is om te onderzoeken of salbutamol beschermt tegen inspiratoire luchtwegobstructie. |
|
E.2.2 | Secondary objectives of the trial |
Investigate the relation between the protective effect of salbutamol against inspiratory airflow obstruction and EIB. |
Onderzoeken wat de relatie is tussen het beschermende effect van salbutamol tegen inspiratoire luchtwegobstructie en expiratoire luchtwegobstructie. |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Clinical history of EIB. - Age 8 till 16 years old. - Ability to run or jump and perform reproducible lung function tests, i.e. coefficient of the predicted value variation in 3 of 5 consecutive measurements < 5%.
|
- voorgeschiedenis van inspanningsastma - leeftijd 8-16 jaar oud - in staat zijn tot het uitvoeren van een inspanningsprovocatietest en het producerende van te reproduceren longfunctietests; de coeffeciënt van de voorspelde waarde varieert in 3 vd 5 opeenvolgende metingen <5%.
|
|
E.4 | Principal exclusion criteria |
- Exacerbation in the last 4 weeks prior to the ECT (hospital admission or use of systemic corticosteroids). - Use of long acting bronchodilators 24 hours before testing. - Use of short acting bronchodilators 8 hours before testing. - Use of leukotriene antagonists 24 hours before testing. - Other pulmonary or cardiac disorder.
|
- exacerbatie in de 4 wk voorafgaand aan de inspanningstest (geen klinische opname of gebruik systemische corticosteroiden). - gebruik van long acting bronchodilatoren binnen 24 uur voor de inspanningstest - gebruik van short acting bronchodilatoren binnen 8 uur voor de inspanningstest - gebruik van leukotriene antagonist binnen 24 uur voor de inspanningstest - andere pulmonale of cardiale aandoening
|
|
E.5 End points |
E.5.1 | Primary end point(s) |
12,5% reduction of MIF50 (Mid Inspiratory Flow) |
12,5% afname van de MIF50 |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
September 2013: recruiting children October 2013- March 2014: Exercise Challenge Tests April 2014 - May 2014: analysis data |
September 2013: includeren patienten Oktober 2013- Maart 2014: inspanningstesten April 2014 - Mei 2014: analyseren data |
|
E.5.2 | Secondary end point(s) |
not applicable |
niet van toepassing |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
not applicable |
niet van toepassing |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
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 | 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 | 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
|
LVLS |
Laatste bezoek laatste patient. |
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |