NCT00357279View on ClinicalTrials.gov

Study of Denufosol Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease

PHASE3CompletedINTERVENTIONAL

Enrollment

352

Participants

Timeline

Start Date

July 31, 2006

Primary Completion Date

September 30, 2008

Study Completion Date

September 30, 2008

Conditions

Cystic Fibrosis

Interventions

DRUG

denufosol tetrasodium (INS37217) Inhalation Solution

Denufosol 60 mg is administered as an inhalation solution, three times daily for six months during the double-blind portion of the study. Subsequently, denufosol 60 mg is administered for an additional six months during the open label safety extension.

DRUG

Placebo - 0.9% w/v sodium chloride solution

4.2 mL of solution, allowing delivery of approximately 4 mL into the nebulizer cup for nebulization, three times daily for six months.

All Listed Sponsors

lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT00357279 - Study of Denufosol Inhalation Solution in Patients With Mild Cystic Fibrosis Lung Disease | Biotech Hunter | Biotech Hunter