Status:
TERMINATED
A Study of Pulmozyme® (Dornase Alpha) in 3- to 5-Year-Old Patients With Cystic Fibrosis
Lead Sponsor:
Genentech, Inc.
Conditions:
Cystic Fibrosis
Eligibility:
All Genders
3-5 years
Phase:
PHASE4
Brief Summary
This was a Phase IV, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the effect of Pulmozyme on pulmonary function, health-related quality of life (HRQOL), and res...
Eligibility Criteria
Inclusion
- Signed Informed Consent Form
- Aged 3-5 years
- Diagnosis of cystic fibrosis
Exclusion
- Children taking scheduled inhaled Pulmozyme or hypertonic saline within 56 days prior to Visit 1 or any Pulmozyme in the 28 days before Visit 1
- Involvement in a clinical intervention trial within the 4 weeks prior to Visit 1
- Use of an investigational drug or device within 28 days prior to Visit 1
- Any other condition that might increase the risk of participation to the patient in the judgement of the investigator
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2009
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT00680316
Start Date
June 1 2008
End Date
May 1 2009
Last Update
January 12 2017
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