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)

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00846781

Acronym

DEFY

Enrollment

308

Registered

2009-02-19

Start date

2009-02-28

Completion date

2011-02-28

Last updated

2015-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

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.

Interventions

DRUGDenufosol tetrasodium Inhalation Solution

60 mg by oral inhalation three times daily

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Rate of change in lung function, as measured by change in FEV1	160 Weeks

Secondary

Measure	Time frame
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
Change in absolute FEV1 from baseline	Weeks 12, 24, 36, 48, 72, 96, 120, 144, and 160
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 hospitalizations/ER visits	160 Weeks
Incidence of early discontinuations from the study	160 Weeks
Number of days hospitalized for a respiratory complaint	160 Weeks

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026