Study 08-114 Open-label Extension of Study 08-110 - A Multi-Center Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis Lung Disease (P08642)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

308 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-02-28

Brief Summary

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The purpose of this study is to obtain data on the potential of long-term treatment with denufosol to improve the clinical course of CF lung disease in patients with mildly impaired lung function and to provide CF patients who completed study 08-110 continued access to denufosol.

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Detailed Description

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Conditions

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Cystic Fibrosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Denufosol tetrasodium Inhalation Solution

Group Type EXPERIMENTAL

Denufosol tetrasodium Inhalation Solution

Intervention Type DRUG

60 mg by oral inhalation three times daily

Interventions

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Denufosol tetrasodium Inhalation Solution

60 mg by oral inhalation three times daily

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Completed Study 08-110

Exclusion Criteria

* A female patient will not be eligible for the study if she is of childbearing potential and is pregnant, lactating, and/or not practicing an acceptable method of birth control (e.g., abstinence, hormonal or barrier methods, partner sterilization, or intrauterine device).
* Have a condition that might affect compliance with study procedures

Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No