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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 intended to be a substitute for qualified health advice, trips or treatment by using a genuine doctor. We aren't doctors. Always consult your mD 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 committed 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 health trials take place in a lot of of cities across the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally measure the potency of new drugs. The aim of the studies / projects is to answer specific human medical questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to discover remedies for all kinds of circumstances, like 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 have health treatment alternatives before they are available to the general public. Many times the test subjects obtain treatment for without cost, and occasionally they are paid for their time. Sometimes 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. Subjects oftentimes recieve the most effective 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, however, and could include additional or frequent doctor visits, healthcare dangers (perhaps life-threatening), and/or the treatment being ineffective. Trials are federally governed with exacting 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. Study of Uridine Triphosphate (UTP) as an Aerosol Spray for Cystic Fibrosis
2. Phase I Randomized Study of Adeno-Associated Virus-CFTR Vector in Patients with Cystic Fibrosis
3. Phase I Study of the Third Generation Adenovirus H5.001CBCFTR in Patients with Cystic Fibrosis
4. Study of Metabolic Effects of Pregnancy in Women With Cystic Fibrosis
5. Increased Gluconeogenesis is One Cause of Cystic Fibrosis Related Diabetes (CFRD)
Related Studies:
Other Cystic Fibrosis Clinical Trials
Other Minnesota Clinical Trials
Other Minneapolis 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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