Saline Hypertonic in Preschoolers with cystic fibrosis and lung structure asmeasured by computedtomography (CT). SHIP-CT study.

Phase 1

• Conditions: Cystic fibrosis; MedDRA version: 19.1Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]

• Registration Number: EUCTR2015-004143-39-DK
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-10-25
• Last Update Posted: 21 July 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Diagnosis of CF as evidenced by one or more clinical features
consistent with the CF phenotype or positive CF newborn screen
AND one or more of the following criteria:
a) A documented sweat chloride = 60 mEq/L by quantitative
pilocarpine iontophoresis (QPIT)
b) A documented genotype with two disease-causing
mutations in the CFTR gene
2. Informed consent by parent or legal guardian
3. Age = 36 months and =72 months at screening visit
4. Ability to comply with medication use, study visits and study
procedures as judged by the site investigator
5. Ability to cooperate with chest CT at the enrolment visit as
determined by the lung function technician
Are the trial subjects under 18? yes
Number of subjects for this age range: 120
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Acute intercurrent respiratory infection, defined as an increase in
cough, wheezing, or respiratory rate with onset within 3 weeks
preceding screening or enrolment visit
3. Acute wheezing at screening or enrolment visit
4. Oxygen saturation < 95% (<90% in centres located above 4000 feet
elevation) at screening or enrolment visit
5. Other major organ dysfunction, excluding pancreatic dysfunction
6. Physical findings that would compromise the safety of the
participant or the quality of the study data as determined by site
investigator
7. Investigational drug use within 30 days prior to screening or
enrolment visit
8. Treatment with inhaled HS at any concentration within 30 days prior
Chest CT within 8 months prior to screening or enrolment visit
9. Initiation (i.e. new prescription) of any inhaled hydrating agent such
as mannitol or mucolytic agents such as dornase alpha within 30
days prior to the screening or enrolment visit
10. Chronic lung disease not related to CF
11. Inability to tolerate first dose of study treatment at the enrolment
visit

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified