Effectiveness of Pulmozyme in Infants With Cystic Fibrosis
Completed · Phase 2 · Has a placebo group
Conditions studied: Cystic Fibrosis
In brief
This is a study to find out whether Pulmozyme is effective for clearing mucus from the airways of children with cystic fibrosis less than 3 ½ years of age.
Key facts
- Study ID
- NCT00179998
- Run by
- Nationwide Children's Hospital
- People needed
- 24
- Starts
- 2005-01-01
- Expected to finish
- 2016-07-01
- Last updated by the study team
- 2019-05-09
Who can join
Age: 0 and older, up to 3. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age < 30 months
- Diagnosis of CF based on clinical features consistent with CF as well as 1 of the 2 following criteria: a) two sweat chlorides >60 mEq/L (by quantitative pilocarpine iontophoresis), b) genotype with 2 identifiable mutations consistent with CF.
- Informed consent by parent or legal guardian
You may not qualify if…
- Previous treatment with Pulmozyme
- Hospitalization or treatment with IV antibiotics with 14 days of initial study visit
- Acute intercurrent respiratory infection, defined as any of the following symptoms within the preceding 48 hours: 1) fever > 38 degrees C, 2) new onset of coryza or other upper respiratory symptoms, 3) increase in cough, wheezing, or respiratory rate
- History of adverse reaction to sedation
- Oxyhemoglobin saturation <90% on room air
- Severe upper airway obstruction as determined by site PI (severe laryngomalacia, markedly enlarged tonsils, significant snoring, diagnosed obstructive sleep apnea)
- Hemodynamically significant congenital heart disease or diagnosed arrhythmias
- History of hemoptysis
- History of previous pulmonary air leak (pneumothorax)
- Diagnosed seizure disorder necessitating current anticonvulsive therapy. A history of febrile seizures is not an exclusion criterion.
- Use of Investigational drug(s) within 60 days or 5 half-lives of enrollment in this study.
- Known allergy to Chinese Hamster Ovary-derived biological products or any component of the placebo or active drug formulations.
Where it is running
- Nationwide Children's Hospital — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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