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Het beschermende effect van een enkele gangbare dosis inhalatiesteroid op inspanningsastma uitgevoerd met verschillende lichaamshoudingen tijdens inhalatie.

The protective effect of a single dose inhaled steroid with different body postures against exercise induced bronchoconstriction.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON28983
Enrollment
38
Registered
2013-04-26
Start date
2013-09-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Exercise Induced Asthma Inspanningsastma

Interventions

1. Interview with investigator about history, complaints and medication use
2. Anthropometric measurements (height, weight)
3. Physical examination (pulmonary auscultation)
4. Two ECT’s, which consists of either running on a treadmill for the older children or jumping on a jumping castle for the younger children for at least 4 minutes (maximum 6 minutes)
5. Four hours prior to each ECT children will inhale a single regular dose of 200 µgr BDP
one time with the standard body posture and head position and one time with the alternative forward leaning body posture with the head flexed backwards. Before inhalation they will perform baseline lu
6. Pulmonary function measurements (flow volume curve) before (duplicated), during (twice) and after exercise at t= 1,2,3,5,7,10 and 15 minutes
7. Parents or child will answer a short questionnaire regarding to the body posture during inhalation of their child.

Sponsors

Stichting Pediatric Research of the Medisch Spectrum Twente.
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Clinical history of asthma symptoms; 2. Age 6 till 16 years; 3. Documented EIB <4weeks prior to the study as measured with an exercise challenge test; 4. Ability to perform reproducible lung function tests, i.e. coefficient of the predicted value variation in 3 of 5 consecutive measurements < 5%.

Exclusion criteria

Exclusion criteria: 1. Exacerbation in the last 4 weeks prior to the ECT (hospital admission or use of systemic corticosteroids); 2. Use of long acting bronchodilators 24 hours before testing; 3. Use of short acting bronchodilators 8 hours before testing; 4. Use of leukotriene antagonists 24 hours before testing; 5. Other pulmonary or cardiac disorder; 6. Use of oral/ nasal/inhaled corticosteroids <2months prior to the study.

Design outcomes

Primary

MeasureTime frame
To investigate the protective effect of a single regular dose of an ICS inhaled with different body postures and head positions against EIB as measured with an ECT with pulmonary lung function measurements (FEV1 and FEV0.5).

Secondary

MeasureTime frame
1. Investigate if body posture and head position during medication inhalation effects inspiratory flow obstruction as measured with spirometry during and after an ECT in asthmatic children of > 12 years old; 2. Investigate with the aid of a questionnaire which body postures and head positions children commonly use during medication inhalation at home.

Contacts

Public ContactR. Visser

Medisch Spectrum Twente Departement of pediatrics Haaksbergerstraat 55

R.Visser@mst.nl+31 (0)53 4872310

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)