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

Completed · Phase 3 · Has a placebo group

Conditions studied: Cystic Fibrosis

In brief

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.

Key facts

Study ID

NCT00625612

Run by

Merck Sharp & Dohme LLC

People needed

466

Starts

2008-02-01

Expected to finish

2010-10-01

Last updated by the study team

2015-11-02

Who can join

Age: 5 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• 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
• Capital Allergy & Respiratory Disease Center — Sacramento, California, United States
• UCSD Medical Center - Hillcrest & Thornton Hospitals — San Diego, California, United States
• UCSD Medical Center - Hillcrest and Thornton Hospitals — San Diego, California, United States
• Pediatric Diagnostic Center — Ventura, California, United States
• Yale School of Medicine — New Haven, Connecticut, United States
• Alfred I. duPont Hospital for Children — Wilmington, Delaware, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Shands at University of Florida — Gainesville, Florida, United States
• Nemours Children's Clinic — Jacksonville, Florida, United States
• Nemours Children's Clinic — Pensacola, Florida, United States
• Pediatric Pulmonary Associates — St. Petersburg, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• St. Mary's Medical Center — West Palm Beach, Florida, United States
• Emory University — Atlanta, Georgia, United States
• Children's Healthcare of Atlanta at Scottish Rite — Atlanta, Georgia, United States
• University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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