A Study in Pediatric Patients With Cystic Fibrosis Lung Disease

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00130182

Enrollment

Registered

2005-08-15

Start date

2005-08-31

Completion date

Unknown

Last updated

2013-05-22

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 purpose of this study is to investigate the safety and effectiveness of two dose strengths of study drug compared to placebo in pediatric patients with cystic fibrosis (CF).

Interventions

DRUGdenufosol tetrasodium (INS37217)

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

5 Years to 7 Years

Healthy volunteers

Inclusion criteria

* Have confirmed diagnosis of CF * Have an FEV1 greater than or equal to 60% * Have oxygen saturation greater than or equal to 90% on room air * Be clinically stable for at least 4 weeks prior to screening * Be able to reproducibly perform spirometry maneuvers

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
respiratory function	—

Secondary

Measure	Time frame
adverse events	—
change in standard safety parameters	—
pulmonary exacerbation	—

Countries

United States

Outcome results

None listed

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