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Article: Inspire Initiates Phase 3 Clinical Trial of Denufosol Tetrasodium in Cystic Fibrosis Patients.
- Article from:
- Business Wire
- Article date:
- July 27, 2006
CopyrightCOPYRIGHT 2006 Business Wire. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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DURHAM, N.C. -- Inspire Pharmaceuticals, Inc. (NASDAQ: ISPH) announced today the initiation of a Phase 3 clinical trial to evaluate its drug candidate, denufosol tetrasodium Inhalation Solution, in patients with mild cystic fibrosis (CF) lung disease.
The initial Phase 3 clinical trial, which will be referred to as TIGER-1 (Transport of Ions to Generate Epithelial Rehydration), is designed to include a 24-week efficacy treatment period, followed by a 24-week safety extension period. The efficacy portion of the trial is a randomized, double-blind comparison of 60 mg of denufosol to placebo by inhalation three times daily in approximately 350 patients with mild ...