Status:
COMPLETED
Infant Study of Inhaled Saline in Cystic Fibrosis
Lead Sponsor:
CF Therapeutics Development Network Coordinating Center
Collaborating Sponsors:
Cystic Fibrosis Foundation
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
4-59 years
Phase:
NA
Brief 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.
Detailed Description
A growing body of evidence supports the importance of intervention in Cystic Fibrosis (CF) lung disease during infancy and early childhood, in order to potentially delay or prevent irreversible lung d...
Eligibility Criteria
Inclusion
- Diagnosis of CF by newborn screening or at least one clinical feature of CF, AND either: (a) A documented sweat chloride ≥ 60 mEq/L by quantitative pilocarpine iontophoresis or (b) A genotype with two identifiable CF-causing mutations
- Informed consent by parent or legal guardian
- Age 4 months to \< 60 months at Enrollment visit. If participating in Infant Pulmonary Function testing (selected sites), age 4 months to \< 16 months at Enrollment visit.
- Ability to comply with medication use, study visits, and study procedures as judged by the site investigator
Exclusion
- Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset in 1 week preceding Enrollment visit
- Acute wheezing at Enrollment visit (prior to HS test dose), or at Infant PFT visit (prior to infant pulmonary function testing), as applicable
- Oxygen saturation \< 95% (\< 90% in centers located above 4000 feet elevation) at Enrollment visit (prior to HS test dose) or at Infant PFT visit (prior to infant pulmonary function testing), as applicable
- Other major organ dysfunction, excluding pancreatic dysfunction
- Physical findings that would compromise the safety of the subject or the quality of the study data as determined by the site investigator
- Investigational drug use within 30 days prior to Enrollment visit, or within 30 days prior to Infant PFT visit as applicable
- Treatment with inhaled hypertonic saline at any concentration within 30 days of Enrollment visit, or within 30 days prior to Infant PFT visit as applicable
- Chronic lung disease not related to CF
- Intolerance of test dose of HS at Enrollment visit
- A sibling that has been randomized and is still enrolled in ISIS002
- Additional Exclusion Criteria for Participation in Infant Pulmonary Function Testing:
- History of adverse reaction to sedation
- Clinically significant upper airway obstruction as determined by the Site Investigator (e.g. severe laryngomalacia, markedly enlarged tonsils, significant snoring, diagnosed obstructive sleep apnea)
- Severe gastroesophageal reflux, defined as persistent frequent emesis despite anti-reflux therapy
- Acute intercurrent respiratory infection, defined as an increase in cough, wheezing, or respiratory rate with onset in 2 weeks preceding visit
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
321 Patients enrolled
Trial Details
Trial ID
NCT00709280
Start Date
April 1 2009
End Date
November 1 2011
Last Update
February 12 2013
Active Locations (30)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
3
Stanford University / Lucile S. Packard Children's Hospital
Palo Alto, California, United States, 94304
4
The Children's Hospital
Aurora, Colorado, United States, 80045