Infant Study of Inhaled Saline in Cystic Fibrosis
Trial ID or NCT#
NCT00709280
Status
RECRUITING
Purpose
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.
Official Title
Infant Study of Inhaled Saline in Cystic Fibrosis
Eligibility Criteria
Ages Eligible for Study: 4 Months to 59 Months
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Inclusion Criteria:
- - 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 Criteria:
- - 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
Investigator(s)
Terry Robinson
Contact us to find out if this trial is right for you.
Contact
Colleen Dunn
6507360388
View on ClinicalTrials.gov
