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

Reversibility of pulmonary function after inhaling salbutamol in different doses in standard and forward leaning body posture in asthmatic children - Body Postures 2

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2013-003941-41-NL
Enrollment
Unknown
Registered
2013-11-05
Start date
2013-11-07
Completion date
Unknown
Last updated
2013-11-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Interventions

Trade Name: Airomir Pharmaceutical Form: Inhalation vapour

Sponsors

Medisch Spectrum Twente
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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.

Design outcomes

Primary

MeasureTime frame
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. 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 January 2014-March 2014: reversibility tests April 2014: Analysis data

Secondary

MeasureTime frame
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. ;Timepoint(s) of evaluation of this end point: Same as timepoint(s) of evaluation of primary end point

Countries

Netherlands

Contacts

Public Contactinvestigator/docter

Medisch Spectrum Twente

r.visser@mst.nl0031534872310

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026