NCT00846781

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
308

participants targeted

Target at P50-P75 for phase_3

Timeline
Completed

Started Feb 2009

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

February 18, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 19, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

November 6, 2015

Status Verified

October 1, 2015

Enrollment Period

2 years

First QC Date

February 18, 2009

Last Update Submit

October 15, 2015

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (1)

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

    160 Weeks

Secondary Outcomes (14)

  • 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

  • +9 more secondary outcomes

Study Arms (1)

Denufosol tetrasodium Inhalation Solution

EXPERIMENTAL
Drug: Denufosol tetrasodium Inhalation Solution

Interventions

Denufosol tetrasodium Inhalation SolutionDRUG

60 mg by oral inhalation three times daily

Denufosol tetrasodium Inhalation Solution

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Completed Study 08-110

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

  • Lynn Smiley, MD

    Medical Monitor

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 18, 2009

First Posted

February 19, 2009

Study Start

February 1, 2009

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

November 6, 2015

Record last verified: 2015-10