Study of Denufosol Tetrasodium in Patients With Cystic Fibrosis Lung Disease

A Multi-Center, Double-Blind, Randomized, Placebo-Controlled, 28-Day Study of Denufosol Tetrasodium (INS37217) Inhalation Solution in Patients With Cystic Fibrosis Lung Disease

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00103714

Enrollment

Registered

2005-02-15

Start date

2005-01-31

Completion date

2005-08-31

Last updated

2015-10-20

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

Conditions

Cystic Fibrosis

Keywords

lung disease

Brief summary

The objectives of this study are to evaluate the safety, tolerability and preliminary efficacy of two dose levels of INS37217 (denufosol tetrasodium) Inhalation Solution in patients with cystic fibrosis (CF) lung disease.

Interventions

DRUGdenufosol tetrasodium (INS37217)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

8 Years to 50 Years

Healthy volunteers

Inclusion criteria

* Have confirmed diagnosis of CF * Have an FEV1 greater than or equal to 60% or less than or equal to 90% of predicted normal * Have oxygen saturation greater than or equal to 90% on room air * Be clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation * Be able to reproducibly perform spirometry maneuvers

Exclusion criteria

* Have changed their physiotherapy technique or schedule within 7 days prior to screening * Have clinically significant comorbidities * Using prior and concurrent medications according to the protocol

Design outcomes

Primary

Measure	Time frame
respiratory function	—

Secondary

Measure	Time frame
adverse events	—
change in standard safety parameters	—
respiratory symptoms via questionnaire	—
pulmonary exacerbation	—

Outcome results

None listed

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