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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00357279 |
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Date of registration:
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25/07/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Study of Denufosol Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease
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Scientific title:
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A Multi-Center, Double-Blind, Placebo-Controlled Randomized, Efficacy and Safety Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease |
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Date of first enrolment:
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July 2006 |
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Target sample size:
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352 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00357279 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Canada
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United States
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Have confirmed diagnosis of cystic fibrosis
- Have FEV1 of greater than or equal to 75% of predicted normal for age, gender, and
height
- Be able to reproducibly perform spirometry maneuvers
- Be clinically stable for at least 4 weeks prior to screening
Exclusion Criteria:
- Have abnormal renal or liver function
- Have chest x-ray at screening suggesting clinically significant active pulmonary
disease
- Be colonized with Burkholderia cepacia
- Have had a lung transplant
Age minimum:
5 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Cystic Fibrosis
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Intervention(s)
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Drug: Placebo - 0.9% w/v sodium chloride solution
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Drug: denufosol tetrasodium (INS37217) Inhalation Solution
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Primary Outcome(s)
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Change in lung function
[Time Frame: 48 weeks]
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Secondary Outcome(s)
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Quality of Life
[Time Frame: 48 weeks]
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Requirements for concomitant CF medications
[Time Frame: 48 weeks]
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Pulmonary exacerbation
[Time Frame: 48 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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