Study of Denufosol Tetrasodium Inhalation Solution in Patients With Cystic Fibrosis (CF) Lung Disease

Phase 3

Completed

• Conditions: Cystic Fibrosis
• Interventions: Drug: Placebo; Drug: Denufosol Tetrasodium (INS37217) Inhalation Solution

• Registration Number: NCT00625612
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of this trial is to evaluate the safety and effectiveness of one dose strength of Denufosol compared to placebo in patients with CF and a predicted FEV1 of greater than or equal to 75% but less than or equal to 110% predicted.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-02-12
• Study First Submitted QC: 2008-02-27
• Study First Posted: 2008-02-28
• Primary Completion: 2010-10
• Study Completion: 2010-10
• 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: 2015-10-08
• Last Update Posted: 2015-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 466

Inclusion Criteria

• Have confirmed diagnosis of cystic fibrosis
• Have FEV1 of greater than or equal to 75% but less than or equal to 110%predicted normal for age, gender and height
• Be able to reproducibly perform spirometry
• Be clinically stable for at least 4 weeks before screening

Exclusion Criteria

• Have abnormal renal or liver function
• Have lung transplant
• Unable to discontinue use of hypertonic saline
• Participated in Inspire trial 08-108

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Placebo	-
1	Denufosol Tetrasodium (INS37217) Inhalation Solution	Denufosol Tetrasodium (INS37217) Inhalation Solution

Primary Outcome Measures

Name	Time	Method
Change in lung function	48 weeks

Secondary Outcome Measures

Name	Time	Method
Pulmonary Exacerbation, Antibiotic Use, Incidence of Hospitalization/ER visits, Health resource utilization, Quality of Life	48 weeks

Trial Locations

Locations (104)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

Pediatric Breathing Disorders; 🇺🇸 Anchorage, Alaska, United States

Phoenix Childrens Hospital; 🇺🇸 Phoenix, Arizona, United States

University of Arizona/Arizona Health Sciences; 🇺🇸 Tucson, Arizona, United States

Childrens Hospital of Los Angeles; 🇺🇸 Los Angeles, California, United States

USC Cystic Fibrosis Center; 🇺🇸 Los Angeles, California, United States

Bay Area Pediatric Pulmonary; 🇺🇸 Oakland, California, United States

Kaiser Permanente Medical Center; 🇺🇸 Oakland, California, United States

Children's Hospital of Orange County; 🇺🇸 Orange, California, United States

Sanford University; 🇺🇸 Palo Alto, California, United States

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