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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	7 April 2015
Main ID:	NCT00004440
Date of registration:	18/10/1999
Prospective Registration:	No
Primary sponsor:	FDA Office of Orphan Products Development
Public title:	Study of Ibuprofen to Preserve Lung Function in Patients With Cystic Fibrosis
Scientific title:
Date of first enrolment:	August 1996
Target sample size:	75
Recruitment status:	Completed
URL:	http://clinicaltrials.gov/show/NCT00004440
Study type:	Interventional
Study design:	Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Phase:	N/A

Countries of recruitment

Contacts

Name:	Michael W Konstan
Address:
Telephone:
Email:
Affiliation:	Case Western Reserve University

Key inclusion & exclusion 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

Age minimum: 5 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Cystic Fibrosis

Intervention(s)

Drug: ibuprofen

Primary Outcome(s)

Secondary Outcome(s)

Secondary ID(s)

199/13438

CWRU-FDR001185

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Case Western Reserve University

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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