Investigation of the applicability of dry powder inhalation in children with cystic fibrosis
Completed
- Conditions
- cystic fibrosismucoviscidosis10024970
- 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
Name Time Method <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
Name Time Method <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>