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Saline Hypertonic in Preschoolers + CT

NCT02950883 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 116

Last updated 2024-03-12

No results posted yet for this study

Summary

The purpose of this study is to assess whether inhalation of 7% hypertonic saline (HS) twice daily for 48 weeks reduces structural lung disease as assessed by computed tomography (CT) in comparison with inhalation of 0.9% isotonic saline (IS) in preschool children (ages 3 to 6) with cystic fibrosis.

Conditions

Interventions

DRUG

Active Treatment Group 7% Hypertonic Saline

Drug: 7% Hypertonic Saline (HS) 4 mL of HS will be administered via inhalation twice daily for 48 weeks. The delivery system is a PARI Sprint Junior nebulizer with a PARI Baby face mask or mouthpiece driven by a PARI compressor (PARI Vios® Pro in USA, PARI BOY SX in Australia and Europe). Other Names: Hyper-Sal™, inhaled saline

DRUG

Control Group 0.9% Isotonic Saline

Drug: 0.9% Isotonic Saline (IS) 4 mL of IS will be administered via inhalation twice daily for 48 weeks The delivery system is the same as that for the test product. Other Names: Normal saline

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • University of Washington, the Collaborative Health Studies Coordinating Center

    lead OTHER

Principal Investigators

  • Harm Tiddens, MD, PhD · Erasmus Medical Centre, Rotterdam

  • Stephen Stick, MD, PhD · Telethon Kids Institute, Perth

  • Margaret Rosenfeld, MD, MPH · Seattle Children's Hospital, Seattle

  • Stephanie Davis, MD · Indiana University, Indianapolis

  • Felix Ratjen, MD, PhD, FRCPC · The Hospital for Sick Children

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-24
Primary Completion
2020-12-15
Completion
2021-06-25

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • Denmark
  • France
  • Italy
  • Netherlands
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02950883 on ClinicalTrials.gov