Change of lung function after inhaling rescue asthma medication in different amounts in straight up and forward leaning body posture in asthmatic childre

Conditions: Asthma
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2013-003941-41-NL

Lead Sponsor: Medisch Spectrum Twente

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

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%.
Are the trial subjects under 18? yes
Number of subjects for this age range: 15
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: 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.;Secondary Objective: 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.<br><br>To measure possible side effects of the salbutamol inhalation (palpitations, tremor, discomfort and rash) with the aid of a self designed questionnaire.;Primary end point(s): FEV1, VC, PEF, MEF25 and MEF75 reversibility (%);Timepoint(s) of evaluation of this end point: January 2014: recruiting children<br>January 2014-March 2014: reversibility tests<br>April 2014: Analysis data

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Possible discomfort body posture measured with VAS scores<br>Possible side effects of the salbutamol inhalation: number of children complaining about palpitations, tremor, discomfort or rash.<br>;Timepoint(s) of evaluation of this end point: Same as timepoint(s) of evaluation of primary end point