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Study Name: Pulmozyme in 3-5 Year Old Children with CF
Study Type: Interventional
Intervention Category: Mucus Alteration
Study Sponsor: Genentech
Study Phase: 4
Recruitment Status: Trial Completed
Study Drug(s): Pulmozyme
Number of Participants Being Recruited: 40
Single / Multi-Center: Multi-Center
STUDY BACKGROUND INFORMATION:
This study looked at the effect of Pulmozyme on preschool aged (3-5 year old) children. The studyĆ¢??s main goal was to see if there was a short term effect of inhaled Pulmozyme on lung function in preschool aged children with CF. Lung function and other outcomes before treatment and after treatment were measured. Lung function was measured using oscillometry, which required that a child breathe normally into a tube (oscillometer) without needing to blow hard and also using spirometry where a child needs to blow hard. The other goals of this study were to explore other ways to assess patient response to Pulmozyme, including quality of life measures and symptom scores (how their breathing feels), and to learn more about the safety of Pulmozyme in this age group.
ELIGIBILITY
Age: 3 Years - 5 Years
FEV1: Not Applicable
P. aeruginosa status: Not applicable
B. cepacia status: Not applicable
Other Primary Eligibility Requirements:

Note: Detailed eligibility criteria information may be available on clinicaltrials.gov. If a specific trial listing for this trial is available, a link to the specific clinicaltrials.gov listing will be present in the "More Information" section below.
FOR MORE INFORMATION:
Sponsor Contact Information: Freemer, Michelle
Trial Specific Link on ClinicalTrials.gov: Not Available
Clinical Research Terms Glossary: Click here
TRIAL RESULTS:
Primary Efficacy:

This study was closed to enrollment early due to an inability to recruit a sufficient number of eligible subjects. No results will be available.

Secondary Efficacy:

Safety:

Citation:

Not Available
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