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Pulmozyme in 3-5 Year Old Children with CF (Genentech Z4240g)
This study looked at the effect of Pulmozyme on preschool aged (3-5 year old) children.
The study’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
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Age:
3 Years to 5 Years -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit
For more information about the results of this study and where it was conducted, visit ClinicalTrials.gov.
Study Results
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What We Learned:
-
Primary Findings:
Effectiveness:
This study was closed to enrollment early due to an inability to recruit a sufficient number of eligible subjects. No results will be available.
Safety:
-
Citation:
For current information about the overall development status of this drug, please check the Drug Development Pipeline.
Study Design
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Study Type: ?more info
Interventional -
Randomized Study: ?more info
Yes -
Placebo Controlled: ?more info
Yes -
Length of Participation:
32 days -
Number of Study Visits:
3
Additional Information
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Phase: ?more info
Phase Four/Post-Approval -
Study Sponsor: ?more info
Genentech -
Study Drugs:
Eligibility
-
Age:
3 Years to 5 Years -
Mutation(s):
No Mutation Requirement -
FEV1% Predicted:
No FEV1 Limit
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