Infant Study of Inhaled Saline in Cystic Fibrosis

Completed · Not applicable

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT00709280

Run by

CF Therapeutics Development Network Coordinating Center

People needed

321

Starts

2009-04-01

Expected to finish

2011-11-01

Last updated by the study team

2013-02-12

Who can join

Age: 0 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• Phoenix Children's Hospital — Phoenix, Arizona, United States
• Stanford University / Lucile S. Packard Children's Hospital — Palo Alto, California, United States
• The Children's Hospital — Aurora, Colorado, United States
• Children's Memorial Hospital and Northwestern University — Chicago, Illinois, United States
• Riley Hospital for Children — Indianapolis, Indiana, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Louisville — Louisville, Kentucky, United States
• Johns Hopkins University / Johns Hopkins Hospital — Baltimore, Maryland, United States
• University of Michigan / C.S. Mott Children's Hospital — Ann Arbor, Michigan, United States
• Children's Hospitals and Clinics of Minnesota — Minneapolis, Minnesota, United States
• Cardinal Glennon Children's Hospital — St Louis, Missouri, United States
• Washington University in St. Louis — St Louis, Missouri, United States
• University of Nebraska — Omaha, Nebraska, United States
• Women and Children's Hospital of Buffalo — Buffalo, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• SUNY Upstate Medical University — Syracuse, New York, United States
• University of North Carolina — Chapel Hill, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Nationwide Children's Hospital, Pulmonary Division — Columbus, Ohio, United States
• The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Texas Children's Hospital — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• University of Virginia - Pediatric Respiratory Medicine — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.