|- candidate number||15481|
|- NTR Number||NTR4191|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||29-sep-2013|
|- Secondary IDs||Body Postures 2 |
|- Public Title||Change of lungfunction after inhaling rescue asthma medication in different amounts in straight up and forward leaning body posture in asthmatic children |
|- Scientific Title||Reversibility of pulmonary function after inhaling salbutamol in different doses in standard and forward leaning body posture in asthmatic children |
|- ACRONYM||Body Postures 2|
|- hypothesis||Inhalation of salbutamol in a forward leaning body posture with the head flexed backwards leads to more reversibility of lung function compared to inhalation with the standard body posture during spirometry in asthmatic children.|
|- Healt Condition(s) or Problem(s) studied||Asthma|
|- 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%.
|- 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.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jan-2014|
|- planned closingdate||1-apr-2014|
|- Target number of participants||15|
|- Interventions||four times spirometry, one time with the inhalation of 200ugr salbutamol in the standard body posture, one time 200ugr salbutamol in the forward leaning body posture with the head flexed backwards and the same two body postures but then with 400ugr salbutamol|
|- Primary outcome||FEV1, VC, PEF, MEF25 and MEF75 reversibility (%)|
|- Secondary outcome||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.
|- Timepoints||01-01-2014 to 01-02-2014: recruiting patients|
01-01-2014 to 01-04-2014: spirometry measurements
01-04-2014 to 01-05-2014: analysis data
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Drs. R. Visser|
|- CONTACT for SCIENTIFIC QUERIES||Drs. R. Visser|
|- Sponsor/Initiator ||Medisch Spectrum Twente|
(Source(s) of Monetary or Material Support)
|Stichting Pediatrisch Onderzoek Enschede|
|- Brief summary||Rationale: The majority of inhaled particles of asthma medication impact in the oropharynx, reducing the dose reaching the lung. This is especially true in children as their airways are smaller. Stretching the airway by a forward leaning posture and head flexed backwards (“sniffing position”) may improve pulmonary deposition and clinical effects. In our previous pilot study we observed a greater salbutamol FEV1 reversibility during spirometry in asthmatic children who inhaled in a forward leaning posture compared to the standard body posture.|
Objective: Main objective of this study is to investigate if a forward leaning body posture with the head flexed backwards during inhalation increases clinical effects of inhaled medication compared to the standard body posture.
Study design: This will be a randomized single-blind prospective cross-over intervention study.
Study population: Children aged six till sixteen years old, with a clinical history of asthma will be recruited from the outpatient clinic of the paediatric department of Medisch Spectrum Twente, Enschede.
Intervention (if applicable): The intervention is a pulmonary function measurement of spirometry at the pulmonary function lab of Medisch Spectrum Twente, Enschede. Children will perform four times a spirometry reversibility assessment. They will inhale 200µgr or 400µgr salbutamol with an autohaler (AiromirTM) in either the standard body posture or in the leaning forward body posture with their head flexed backwards in a randomized order.
Main study parameters/endpoints: Reversibility of FEV1, VC, PEF, MEF25 and MEF75 in relation to the body posture and head position during inhalation; standard or leaning forward with the head flexed backward.
|- Main changes (audit trail)|
|- RECORD||29-sep-2013 - 8-okt-2013|