Saline hypertonic in preschoolers and lung structure as measured by computed tomography.

Phase 1

• Conditions: Cystic Fibrosis; MedDRA version: 20.0Level: PTClassification code 10011763Term: Cystic fibrosis lungSystem Organ Class: 10010331 - Congenital, familial and genetic disorders; MedDRA version: 20.0Level: PTClassification code 10011762Term: Cystic fibrosisSystem 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-IT
• Lead Sponsor: Erasmus MC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-09-20
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

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

Inclusion Criteria

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 = 60 mEq/L by quantitative pilocarpineiontophoresis (QPIT) b) A documented genotype with two disease-causing mutations in the CFTR gene
Informed consent by parent or legal guardian
Age = 36 months and =72 months at Screening visit
Ability to comply with medication use, study visits and study procedures as judged by the site investigator
***Ability to execute a technician controlled or spirometer controlled chest CT scan***????

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

Chest CT within 8 months prior to the Screening visit
Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset within 3 weeks preceding Screening or Enrolment visit
Acute wheezing at Screening or Enrollment visit
Oxygen saturation < 95% (<90% at centres above 4000 feet elevation) at Screening or Enrollment visit
Other major organ dysfunction, excluding pancreatic dysfunction
Physical findings that would compromise the safety of the participant or the quality of the study data as determined by site investigator
Investigational drug use within 30 days prior to Screening or Enrolment visit
Treatment with inhaled hypertonic saline at any concentration within 30 days prior to Screening or Enrolment visit
Start of any additional inhaled saline solution at any concentration, or other hydrating agent such as mannitol or mucolytic drug such as dornase alpha within 30 days prior or following the Screening or Enrollment visit
Chronic lung disease not related to CF
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