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Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung Disease



Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung Disease

For Condition: Cystic Fibrosis
Status: No longer recruiting
Sponsor(s): Inspire Pharmaceuticals , Cystic Fibrosis Foundation Therapeutics
Synopsis: The purpose of this study is to assess the safety and effectiveness of multiple dosages of INS37217 compared to placebo over 28 days in subjects with mild to moderate cystic fibrosis (CF) lung disease. Study drug will be administered through a nebulizer (a device that delivers medication as a mist by breathing it in).
Details: The purpose of this study is to: - assess the safety and efficacy of multiple dose levels of INS37217 compared to placebo over 28 days in subjects with mild to moderate CF lung disease; - explore evidence of activity of INS37217 and placebo administered via PARI LC STAR nebulizer; - identify dose(s) that will be studied in subsequent trials.
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 8 Years/50 Years
Genders: Both
Protocol Entry Criteria: - confirmed diagnosis of CF - FEV1 greater than or equal to 75% of predicted normal - oxyhemoglobin saturation greater than or equal to 90% - clinically stable
Total Enrollment: 92

Location and Contact Information:

University of Washington Medical Center
Seattle,  Washington,  98195
United States
 

The Children's Hospital
Denver,  Colorado,  80218
United States
 

Texas Children's Hospital
Houston,  Texas,  77030
United States
 

Cincinnati's Children's Hospital Medical Center
Cincinnati,  Ohio,  45229-3039
United States
 

University of North Carolina - Chapel Hill
Chapel Hill,  North Carolina,  27514
United States
 

Stanford University Hospital and Clinics
Palo Alto,  California,  94305
United States
 

Children's Hospital
Boston,  Massachusetts,  02115
United States
 

Vanderbilt University Medical Center
Nashville,  Tennessee,  37232
United States
 

Cardinal Glennon Children's Hospital
St. Louis,  Missouri,  63104
United States
 

The Johns Hopkins Hospital
Baltimore,  Maryland,  21287
United States
 

Children's Memorial Hospital
Chicago,  Illinois,  60614
United States
 

Massachusetts General Hospital
Boston,  Massachusetts,  02114
United States
 

University of Minnesota General Clinical Research Center
Minneapolis,  Minnesota,  55455
United States
 

Columbus Children's Hospital
Columbus,  Ohio,  43205
United States
 

Fairview University Medical Center
Minneapolis,  Minnesota,  55455
United States
 

Children's Hospital and Regional Medical Center
Seattle,  Washington,  98105
United States
 


Additional Information:
Study ID Numbers:
  08-103; 
Study Start Date: March 2003
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00056147

Other Cystic Fibrosis Studies:
1. Study of Uridine Triphosphate (UTP) as an Aerosol Spray for Cystic Fibrosis

2. Bone Health of People with Cystic Fibrosis

3. Study of INS37217 Inhalation Solution in Mild to Moderate Cystic Fibrosis Lung Disease

4. Study of Tauroursodeoxycholic Acid for Hepatobiliary Disease in Cystic Fibrosis

5. A multi-centered study of the long-term effect of salmeterol and albuterol in cystic fibrosis

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