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Tolerability of Inhaled Hypertonic Saline in Infants With Cystic Fibrosis

NCT00546663 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2011-08-24

No results posted yet for this study

Summary

This is an open-label pilot study of the safety and tolerability of 7% hypertonic saline inhaled twice daily for 14 days in infants with CF, 12 to 30 months of age.

Conditions

Interventions

DRUG

inhaled 7% hypertonic saline (HS)

7% hypertonic saline administered twice daily for 14 days by nebulization. A Pari Sprint Junior nebulizer equipped with a Pari Baby face mask and a Pari Proneb compressor will be used to administer the HS (PARI Respiratory Equipment, Inc., Midlothian, VA). To minimize the risk of cough and bronchospasm with HS inhalation, infants will be pre-treated prior to each dose of HS with albuterol by metered dose inhaler

Sponsors & Collaborators

  • Cystic Fibrosis Foundation

    collaborator OTHER

  • CF Therapeutics Development Network Coordinating Center

    lead NETWORK

Principal Investigators

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

  • Stephanie Davis, MD · University of North Carolina

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

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Months
Max Age
30 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2008-05-31
Completion
2008-07-31

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 NCT00546663 on ClinicalTrials.gov