Status:
COMPLETED
Effectiveness of Pulmozyme in Infants With Cystic Fibrosis
Lead Sponsor:
Nationwide Children's Hospital
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
1-30 years
Phase:
PHASE2
Brief Summary
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.
Detailed Description
Pulmozyme is given using a nebulizer and is now widely used in older children and adults with cystic fibrosis. In adults and older children, studies have shown that daily use of Pulmozyme improves lun...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT00179998
Start Date
January 1 2005
End Date
July 1 2016
Last Update
May 9 2019
Active Locations (1)
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1
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205