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

Phase 3

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: denufosol tetrasodium (INS37217) Inhalation Solution; Drug: Placebo - 0.9% w/v sodium chloride solution

• Registration Number: NCT00357279
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this trial is to evaluate the safety and effectiveness of a one dose strength of denufosol compared to placebo in patients with mild CF lung disease.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-07
• Study First Submitted: 2006-07-25
• Study First Submitted QC: 2006-07-26
• Study First Posted: 2006-07-27
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Disposition First Submitted: 2011-03-24
• Disposition First Submitted QC: 2011-03-30
• Disposition First Posted: 2011-04-07
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-09
• Last Update Posted: 2015-11-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 352

Inclusion Criteria

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

Exclusion Criteria

• Have abnormal renal or liver function
• Have chest x-ray at screening suggesting clinically significant active pulmonary disease
• Be colonized with Burkholderia cepacia
• Have had a lung transplant

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	denufosol tetrasodium (INS37217) Inhalation Solution	-
1	Placebo - 0.9% w/v sodium chloride solution	Placebo

Primary Outcome Measures

Name	Time	Method
Change in lung function	48 weeks

Secondary Outcome Measures

Name	Time	Method
Pulmonary exacerbation	48 weeks
Quality of Life	48 weeks
Requirements for concomitant CF medications	48 weeks