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8-Day Safety, Tolerability, and Effects Study of Inhaled INS37217 and Placebo In Adult and Pediatric Cystic Fibrosis Patients Clinical Trials Information presented on Clinical Trials Search is not designed to be a substitute for proven healthcare advice, travels to or treatment by using a genuine medical doctor. We are not physicians. Always confer with your doctor on 8-Day Safety, Tolerability, and Effects Study of Inhaled INS37217 and Placebo In Adult and Pediatric Cystic Fibrosis Patients conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. 8-Day Safety, Tolerability, and Effects Study of Inhaled INS37217 and Placebo In Adult and Pediatric Cystic Fibrosis Patients Clinical research trials and 8-Day Safety, Tolerability, and Effects Study of Inhaled INS37217 and Placebo In Adult and Pediatric Cystic Fibrosis Patients healthcare trials take place in many of cities across the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the effectiveness of new drugs. The function of the studies / undertakings is to answer specific human medical questions. Clinical trials are a popular means for mDs, government agencies, and private sector companies to find treatments for all forms of conditions, including 8-Day Safety, Tolerability, and Effects Study of Inhaled INS37217 and Placebo In Adult and Pediatric Cystic Fibrosis Patients. 8-Day Safety, Tolerability, and Effects Study of Inhaled INS37217 and Placebo In Adult and Pediatric Cystic Fibrosis Patients Clinical Trials and other clinical trials allow for volunteers to access medical treatment alternatives before they are available to the masses. Many times the test subjects undergo treatment for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a 8-Day Safety, Tolerability, and Effects Study of Inhaled INS37217 and Placebo In Adult and Pediatric Cystic Fibrosis Patients clinical trial. Test subjects oftentimes recieve the best healthcare possible for their 8-Day Safety, Tolerability, and Effects Study of Inhaled INS37217 and Placebo In Adult and Pediatric Cystic Fibrosis Patients condition. Hazards are a reality, nonetheless, and might include additional or frequent doctor trips, healthcare hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "8" Clinical Trials Conditions > 8-Day Safety, Tolerability, and Effects Study of Inhaled INS37217 and Placebo In Adult and Pediatric Cystic Fibrosis Patients  8-Day Safety, Tolerability, and Effects Study of Inhaled INS37217 and Placebo In Adult and Pediatric Cystic Fibrosis Patients
8-Day Safety, Tolerability, and Effects Study of Inhaled INS37217 and Placebo In Adult and Pediatric Cystic Fibrosis Patients
For Condition: Cystic Fibrosis
Status: Completed
Sponsor(s): Inspire Pharmaceuticals ,
Synopsis: The purpose of this ascending dose group study is to assess the safety, tolerability, and effects of multiple dose levels of INS37217 and placebo followed by five days twice daily treatment with maximum tolerated dose administered by inhalation via the Pari LC Star nebulizer in adult and pediatric patients with cystic fibrosis
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 5 Years/
Genders: Both
Protocol Entry Criteria: FEV1 40-70% (adults), FEV1 >/=50% (pediatrics), oxygen saturation >90%, clinically stable, willing to stay overnight
Total Enrollment:
Location and Contact Information:
University of North Carolina Chapel Hill
Chapel Hill, North Carolina, 27514
United States
University of Utah
Salt Lake City, Utah, 84132
United States
Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106
United States
The Johns Hopkins Hospital
Baltimore, Maryland, 21287
United States
The Children's Hospital
Denver, Colorado, 80218
United States
Children's Hospital and Regional Medical Center
Seattle, Washington, 98105
United States
University of Minnesota Medical School
Minneapolis, Minnesota, 55455
United States
Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
United States
Additional Information:
Study ID Numbers: 08-102;
Study Start Date: June 2001
Record last reviewed: August 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00034515
Other Cystic Fibrosis Studies:
1. Benefits and Risks of Newborn Screening for Cystic Fibrosis
2. Phase I Study of Liposome-Mediated Gene Transfer in Patients with Cystic Fibrosis
3. Study of Total Energy Expenditure in Infants and Children With Moderate to Severe Cystic Fibrosis
4. Quantification of pulmonary neutrophil activity in cystic fibrosis using radiolabeled fluorodeoxyglucose and PET imaging
5. Study of Metabolic Effects of Pregnancy in Women With Cystic Fibrosis
Related Studies:
Other Cystic Fibrosis Clinical Trials
Other North Carolina Clinical Trials
Other Chapel Hill Clinical Trials
8-Day Safety, Tolerability, and Effects Study of Inhaled INS37217 and Placebo In Adult and Pediatric Cystic Fibrosis Patients
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