Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
CF Therapeutics Development Network Coordinating Center Cystic Fibrosis Foundation |
---|---|
Information provided by: | CF Therapeutics Development Network Coordinating Center |
ClinicalTrials.gov Identifier: | NCT00546663 |
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.
Condition | Intervention |
---|---|
Cystic Fibrosis |
Drug: inhaled 7% hypertonic saline (HS) |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety Study |
Official Title: | A Pilot Study to Evaluate the Tolerability of Inhaled 7% Hypertonic Saline in Infants With Cystic Fibrosis |
Enrollment: | 19 |
Study Start Date: | September 2007 |
Study Completion Date: | July 2008 |
Primary Completion Date: | May 2008 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Open-label: Experimental |
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 |
The efficacy and safety of hypertonic saline (HS) in CF patients over 6 years of age has been demonstrated in clinical trials of 2 to 48 weeks' duration.
Based on these results, a large randomized, placebo-controlled trial of the efficacy and safety of 7% HS administered twice daily for 48 weeks to infants with CF, 4 to 15 months of age at enrollment, is planned (the Infant Study of Inhaled Saline (ISIS) trial). It is anticipated that 150 infants at up to 16 sites will be enrolled in the ISIS trial. To date, the only evaluations of the safety of HS in infants with CF have been small single-dose studies. There has been no evaluation of the tolerability of chronic HS administration. The goal of this study is to assess the safety and tolerability of exposure to 14 days of 7% HS administered twice daily in infants with CF, prior to enrolling subjects in the planned large, randomized, controlled trial. Conduct of this study will provide evidence for the tolerability of chronic HS administration in infants with CF and estimates of the proportion of infants who do not tolerate chronic HS treatment. The results will be used to establish the appropriate measures of tolerability at enrollment in the ISIS trial, and to refine sample size estimates to account for withdrawal due to intolerance of HS.
Ages Eligible for Study: | 12 Months to 30 Months |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, North Carolina | |
University of North Carolina | |
Chapel Hill, North Carolina, United States, 27599-7248 | |
United States, Washington | |
Children's Hospital and Regional Medical Center | |
Seattle, Washington, United States, 98105 | |
Canada, Ontario | |
Hospital for Sick Children | |
Toronto, Ontario, Canada, M5G 1X8 |
Principal Investigator: | Margaret Rosenfeld, MD, MPH | Seattle Children's Hospital |
Principal Investigator: | Stephanie Davis, MD | University of North Carolina |
Principal Investigator: | Felix Ratjen, MD, PhD | Hospital for Sick Children, Toronto |
Responsible Party: | Cystic Fibrosis Foundation Therapeutics, Inc. ( Medical Affairs ) |
Study ID Numbers: | ISIS001 |
Study First Received: | October 17, 2007 |
Last Updated: | April 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00546663 History of Changes |
Health Authority: | United States: Institutional Review Board; Canada: Health Canada; Canada: Ethics Review Committee |
Cystic Fibrosis, hypertonic saline |
Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis Fibrosis |
Lung Diseases Albuterol Infant, Newborn, Diseases Pancreatic Diseases |
Pathologic Processes Digestive System Diseases Genetic Diseases, Inborn Respiratory Tract Diseases Cystic Fibrosis |
Fibrosis Lung Diseases Infant, Newborn, Diseases Pancreatic Diseases |