Saline Hypertonic in Preschoolers with Cystic Fibrosis and lung structure as measured by computed tomography (CT). SHIP-CT study.

Phase 3

Completed

• Conditions: Cystic Fibrosis; Human Genetics and Inherited Disorders - Cystic fibrosis

• Registration Number: ACTRN12615001067561
• Lead Sponsor: Telethon Kids Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-10-13
• Study Completion: 2020-08-31
• Last Update Posted: 15 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 116

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 greater than or equal to 60 mEq/L by quantitative pilocarpineiontophoresis (QPIT)
b) A documented genotype with two disease-causing mutations in the CFTR gene
2. Informed consent by parent or legal guardian
3. Age greater than or equal to 36 months and less than or equal to 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 perform a chest CT at the enrolment visit

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
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 to screening or enrolment visit
9. 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 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
• Study Design: Not specified