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Investigation of the applicability of dry powder inhalation in children with cystic fibrosis

Completed
Conditions
cystic fibrosis
mucoviscidosis
10024970
Registration Number
NL-OMON40571
Lead Sponsor
Rijksuniversiteit Groningen
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
40
Inclusion Criteria

- A physician*s diagnosis of CF
- 4 to 14 years of age
- Informed consent from the parent(s)/guardian(s)
- Assent from the child (informed consent when >=12 years of age)

Exclusion Criteria

No exclusion criteria are formulated.

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The main study parameter is the ability of a child to achieve a proper<br /><br>inhalation manoeuvre with the test inhaler, which is reflected in the pressure<br /><br>drop they create over the inhaler upon inhalation.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>From the (duration of the) pressure drop, various inspiratory parameters will<br /><br>be calculated per airflow resistance. The incidence of obstructions in the oral<br /><br>cavity upon inhalation will be expressed as percentage of the total number of<br /><br>observations.</p><br>
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