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

Merck Sharp & Dohme LLC0 sites72 target enrollmentJanuary 2005

ConditionsCystic Fibrosis

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Cystic Fibrosis
Sponsor: Merck Sharp & Dohme LLC
Enrollment: 72
Primary Endpoint: respiratory function
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

January 2005

End Date

August 2005

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Merck Sharp & Dohme LLC

Responsible Party

Sponsor

Eligibility Criteria

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