Saline hypertonic in preschoolers and lung structure as measured by computed tomography.
- Conditions
- Cystic Fibrosis (CF)
- Registration Number
- NL-OMON28150
- Lead Sponsor
- Erasmus Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 120
Inclusion Criteria
1. Diagnosis of CF as evidenced by one or more clinical feature consistent with the CF phenotype or positive CF newborn screen AND one or more of the following criteria:
a) A documented sweat chloride ¡Ý 60 mEq/L by quantitative pilocarpine iontophoresis (QPIT)
Exclusion Criteria
1. Chest CT within 8 months prior to the Screening visit
2. Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset within 3 weeks preceding Screening or Enrolment visit
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The difference in PRAGMA-CF %Dis between HS and IS study arm at end of study (48 weeks), measured from standardized chest CT.
- Secondary Outcome Measures
Name Time Method ongitudinal change in airway disease (%Dis), bronchiectasis (%Bx) and trapped air (%TA), as well as the proportion of patients with bronchiectasis progression, from baseline to end of study as established by PRAGMA-CF and Airway dimensions as measured using the AA method from chest CT <br /><br>• on expiratory or spontaneous breathing CTs <br /><br>• Longitudinal change in LCI, measured by N2 MBW, from baseline to 48 weeks between treatment arms.<br /><br>• Protocol-defined pulmonary exacerbation rate <br /><br>• Modified parent-reported CFQ-R for preschool children, a CF-specific measure of health related quality of life (excluding European sites).<br /><br>