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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)

NCT00846781 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 308

Last updated 2015-11-06

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Denufosol tetrasodium Inhalation Solution

60 mg by oral inhalation three times daily

Sponsors & Collaborators

Principal Investigators

  • Lynn Smiley, MD · Medical Monitor

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-02-28
Primary Completion
2011-02-28
Completion
2011-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00846781 on ClinicalTrials.gov