Not Signed In -
Cystic Fibrosis |
CF; Cystic Fibrosis Research Directions; Fibrocystic Disease of Pancreas; Mucoviscidosis |
Clinical Trial: A Study in Pediatric Patients with Cystic Fibrosis Lung Disease
This study is currently recruiting patients.
Verified by Inspire Pharmaceuticals August 2005
|
Purpose
The purpose of this study is to investigate the safety and effectiveness of two dose strengths of study drug compared to placebo in pediatric patients with CF.
| Condition | Intervention | Phase |
|---|---|---|
| Cystic Fibrosis | Drug: denufosol tetrasodium (INS37217) | Phase II |
MedlinePlus related topics: Cystic Fibrosis
Genetics Home Reference related topics: cystic fibrosis
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Further Study Details:
Primary Outcomes: respiratory function
Secondary Outcomes: adverse events; change in standard safety parameters; pulmonary exacerbation
Expected Total Enrollment: 15
Secondary Outcomes: adverse events; change in standard safety parameters; pulmonary exacerbation
Expected Total Enrollment: 15
Study start: August 2005
Eligibility
Ages Eligible for Study: 5 Years - 7 Years, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
- Have confirmed diagnosis of CF
- Have an FEV1 greater than or equal to 60%
- Have oxygen saturation greater than or equal to 90% on room air
- Be clinically stable for at least 4 weeks prior to screening
- Be able to reproducibly perform spirometry maneuvers
Exclusion Criteria:
- Have clinically significant comorbidities
- Have changed their physiotherapy technique or schedule within 7 days prior to screening
- Using prior and concurrent medications according to protocol
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00130182
Dave Mathews 877-800-4536 dmathews@inspirepharm.com
Colorado
The Children''''s Hospital, Denver, Colorado, 80218, United States; Recruiting
More Information
Study ID Numbers: 08-107
Last Updated: August 12, 2005
Record first received: August 11, 2005
ClinicalTrials.gov Identifier: NCT00130182
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23
Last Updated: August 12, 2005
Record first received: August 11, 2005
ClinicalTrials.gov Identifier: NCT00130182
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-08-23
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