Search Clinical Trials
 
By Condition
 
By Location (USA)
 
By Location (Other)
 
By Sponsor
 
Resources
 
Privacy Policy
 
About Us
Disclaimer
Study of Ibuprofen to Preserve Lung Function in Patients with Cystic Fibrosis Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Study of Ibuprofen to Preserve Lung Function in Patients with Cystic Fibrosis conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Study of Ibuprofen to Preserve Lung Function in Patients with Cystic Fibrosis Clinical research trials and Study of Ibuprofen to Preserve Lung Function in Patients with Cystic Fibrosis medical trials take place in many of places throughout the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Study of Ibuprofen to Preserve Lung Function in Patients with Cystic Fibrosis. Study of Ibuprofen to Preserve Lung Function in Patients with Cystic Fibrosis Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Study of Ibuprofen to Preserve Lung Function in Patients with Cystic Fibrosis clinical trial. Test subjects typically obtain the finest healthcare available for their Study of Ibuprofen to Preserve Lung Function in Patients with Cystic Fibrosis condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.

Home > "S" Clinical Trials Conditions > Study of Ibuprofen to Preserve Lung Function in Patients with Cystic Fibrosis

Study of Ibuprofen to Preserve Lung Function in Patients with Cystic Fibrosis



Study of Ibuprofen to Preserve Lung Function in Patients with Cystic Fibrosis

For Condition: Cystic Fibrosis
Status: Completed
Sponsor(s): FDA Office of Orphan Products Development , Case Western Reserve University
Synopsis: OBJECTIVES: I. Determine the effect of different doses of ibuprofen on neutrophil (polymorphonuclear leukocyte; PMN) delivery to a mucosal surface (the oral mucosa) in patients with cystic fibrosis and healthy controls. II. Determine the duration of effect (and possible rebound effect) of ibuprofen on PMN delivery to a mucosal surface in these patients.
Details: PROTOCOL OUTLINE: This is an open label study. Patients are randomized into 5 arms, each consisting of 10 healthy volunteers and 5 patients with cystic fibrosis, based on the amount of ibuprofen received during the treatment period. The study period lasts for at least 15 days and consists of 3 periods: baseline (days 1-3), treatment (days 3-12), and recovery (days 13-15 or longer). During the treatment period patients receive ibuprofen orally every 12 hours (except for a control arm that receives no ibuprofen).
Eligibility:
Study Type:  Interventional, Treatment, Randomized, Open Label
Minimum Age/Maximum Age: 5 Years/
Genders: Both
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Confirmed diagnosis of cystic fibrosis (CF) based on: Sweat chloride greater than 60 mEq/L AND Typical pulmonary and/or gastrointestinal manifestation of CF OR Healthy volunteers --Prior/Concurrent Therapy-- At least 30 days since medications with anti-neutrophil or anti-inflammatory effect (e.g., aspirin, nonsteroidal anti-inflammatory drugs [NSAIDs], corticosteroids, macrolide antibiotics) --Patient Characteristics-- Age: Patients with cystic fibrosis (CF): 5 and over; Healthy volunteers: 18 and over Hematopoietic: No significant history of hematologic disease Hepatic: No significant history of hepatic disease Renal: No significant history of renal disease Cardiovascular: No significant history of cardiovascular disease Pulmonary: See Disease Characteristics Neurologic: No significant history of neurologic disease Other: Not pregnant; No significant history of peptic ulcer disease; Patients with CF free of any acute illness within 14 days; No prior hypersensitivity to any NSAID
Total Enrollment: 75

Location and Contact Information:

Overall Study Official:
MichaelKonstan,  Study Chair,  Case Western Reserve University


Additional Information:
Study ID Numbers:  199/13438;  CWRU-FDR001185
Study Start Date: August 1996
Record last reviewed: April 2000
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004440

Other Cystic Fibrosis Studies:
1. Pressure support ventilation during CF exacerbations

2. Randomized Study of Alendronate in Adult Patients With Cystic Fibrosis Related Osteoporosis

3. Randomized Study of Pancrelipase With Bicarbonate (PANCRECARB) Capsules in Reducing Steatorrhea in Patients With Cystic Fibrosis

4. Study of Ibuprofen to Preserve Lung Function in Patients with Cystic Fibrosis

5. Phase I Randomized Study of Adeno-Associated Virus-CFTR Vector in Patients with Cystic Fibrosis

Related Studies:

Other Cystic Fibrosis Clinical Trials
Other Clinical Trials
Other Clinical Trials

Study of Ibuprofen to Preserve Lung Function in Patients with Cystic Fibrosis
Modify your Search

  Other Cystic Fibrosis Clinical Trials
  Other Clinical Trials
  Other Clinical Trials


Warning: include(/var/www/cgi-bin/traxis/counter.php) [function.include]: failed to open stream: No such file or directory in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103

Warning: include() [function.include]: Failed opening '/var/www/cgi-bin/traxis/counter.php' for inclusion (include_path='.:/usr/local/lib/php') in /home/cts/domains/clinicaltrialssearch.org/public_html/index.php on line 103