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Clinical Trials/NCT00846781
NCT00846781TerminatedPhase 3

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)

Merck Sharp & Dohme LLC0 sites308 target enrollmentStarted: February 2009Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Phase 3
Status
Terminated
Enrollment
308
Primary Endpoint
Rate of change in lung function, as measured by change in FEV1
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study Overview

Brief 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.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
5 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Denufosol tetrasodium Inhalation Solution

Experimental

Intervention: Denufosol tetrasodium Inhalation Solution (Drug)

Outcomes

Primary Outcomes

Rate of change in lung function, as measured by change in FEV1

Time Frame: 160 Weeks

Secondary Outcomes

  • Change in absolute FEV1 from baseline(Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160)
  • Change in FEV1 percent predicted value from baseline(Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160)
  • Change in FEF25%-75% and forced vital capacity (FVC) from baseline(Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160)
  • Incidence of pulmonary exacerbations(160 Weeks)
  • Changes in Pseudomonas aeruginosa status(160 Weeks)
  • Number of days of intravenous (IV) antibiotic use for a respiratory complaint(160 Weeks)
  • Incidence of hospitalizations/Emergency room (ER) visits for a respiratory complaint(160 Weeks)
  • Number of days hospitalized for a respiratory complaint(160 Weeks)
  • Incidence of hospitalizations/ER visits(160 Weeks)
  • Incidence of treatment emergent adverse events (AEs), serious adverse events (SAEs) and withdrawals due to AEs(160 Weeks)
  • Incidence of patients with significant decrease in absolute FEV1 at any visit from baseline(160 Weeks)
  • Changes in physical exam findings including height, weight, and body mass index from baseline(Weeks 48, 96, and 160)
  • Changes in hematology, serum chemistry, and urinalysis parameters from baseline(Weeks 24, 48, 72, 96, 120, 144, and 160)
  • Incidence of early discontinuations from the study(160 Weeks)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

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