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.1.3 | 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 clinical effect of 200µgr and 400µgr salbutamol inhaled with the forward leaning body posture compared to the standard body posture on the reversibility of pulmonary function variables. |
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E.2.2 | Secondary objectives of the trial |
To measure the possible discomfort body posture with the aid of a questionnaire partly based on the child VAS scores questionnaire and the body part discomfort scale questionnaire.
To measure possible side effects of the salbutamol inhalation (palpitations, tremor, discomfort and rash) with the aid of a self designed questionnaire. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Clinical history of asthma symptoms. - Age 6 till 16 years old. - Ability to perform reproducible pulmonary function tests, i.e. coefficient of the predicted value variation in 3 of 5 consecutive measurements < 5%. |
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E.4 | Principal exclusion criteria |
- Exacerbation in the last 4 weeks prior to the study (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.
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E.5 End points |
E.5.1 | Primary end point(s) |
FEV1, VC, PEF, MEF25 and MEF75 reversibility (%) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
January 2014: recruiting children January 2014-March 2014: reversibility tests April 2014: Analysis data |
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E.5.2 | Secondary end point(s) |
Possible discomfort body posture measured with VAS scores Possible side effects of the salbutamol inhalation: number of children complaining about palpitations, tremor, discomfort or rash.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Same as timepoint(s) of evaluation of primary end point |
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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 | 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 | Yes |
E.8.1.4 | Double blind | No |
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 | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
two different doses of airomir and two different body postures |
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E.8.2.4 | Number of treatment arms in the trial | 4 |
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 | |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |