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Infant Study of Inhaled Saline in Cystic Fibrosis

NCT00709280 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 321

Last updated 2013-02-12

No results posted yet for this study

Summary

The purpose of this study is to assess whether 7% hypertonic saline (HS) is an effective and safe therapy in infants and young children with CF.

Conditions

Interventions

DRUG

7% Hypertonic Saline (HS)

Administered via inhalation twice daily for 48 ± 4 weeks. The delivery system is a PARI Sprint Junior nebulizer with a PARI Baby face mask or mouthpiece driven by a PARI Pro Neb compressor.

DRUG

0.9% Isotonic Saline (IS)

Administered via inhalation twice daily for 48 ± 4 weeks. The delivery system is a PARI Sprint Junior nebulizer with a PARI Baby face mask or mouthpiece driven by a PARI Pro Neb compressor.

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • CF Therapeutics Development Network Coordinating Center

    lead NETWORK

Principal Investigators

  • Stephanie Davis, MD · University of North Carolina, Chapel Hill

  • Margaret Rosenfeld, MD, MPH · Children's Hospital and Regional Medical Center

  • Felix Ratjen, MD, PhD · University of Toronto Hospital for Sick Children

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
4 Months
Max Age
59 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2011-10-31
Completion
2011-11-30

Countries

  • United States
  • Canada

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 NCT00709280 on ClinicalTrials.gov