Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease

A Phase 3, International, Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis Lung Disease and FEV1 Greater Than or Equal to 75% Predicted But Less Than or Equal to 110% Predicted

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00625612

Enrollment

466

Registered

2008-02-28

Start date

2008-02-29

Completion date

2010-10-31

Last updated

2015-11-02

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 trial is to evaluate the safety and effectiveness of one dose strength of Denufosol compared to placebo in patients with CF and a predicted FEV1 of greater than or equal to 75% but less than or equal to 110% predicted.

Interventions

DRUGDenufosol Tetrasodium (INS37217) Inhalation Solution

Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution, Denufosol 60 mg is administered as an inhalation solution, three times daily for twelve months.

DRUGPlacebo

Placebo - 0.9% w/v sodium chloride solution, three times daily for twelve months.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

5 Years to No maximum

Healthy volunteers

Inclusion criteria

* Have confirmed diagnosis of cystic fibrosis * Have FEV1 of greater than or equal to 75% but less than or equal to 110%predicted normal for age, gender and height * Be able to reproducibly perform spirometry * Be clinically stable for at least 4 weeks before screening

Exclusion criteria

* Have abnormal renal or liver function * Have lung transplant * Unable to discontinue use of hypertonic saline * Participated in Inspire trial 08-108

Design outcomes

Primary

Measure	Time frame
Change in lung function	48 weeks

Secondary

Measure	Time frame
Pulmonary Exacerbation, Antibiotic Use, Incidence of Hospitalization/ER visits, Health resource utilization, Quality of Life	48 weeks

Countries

Australia, Canada, New Zealand, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026