NCT00004440

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 1996

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 1996

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 1999

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

October 18, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 19, 1999

Completed
Last Updated

March 25, 2015

Status Verified

April 1, 2000

First QC Date

October 18, 1999

Last Update Submit

March 24, 2015

Conditions

Cystic Fibrosis

Keywords

cardiovascular and respiratory diseasescystic fibrosisgenetic diseases and dysmorphic syndromesrare disease

Interventions

ibuprofenDRUG

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

MeSH Terms

Conditions

Cystic FibrosisRespiratory Tract DiseasesGenetic Diseases, InbornRare Diseases

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Officials

  • Michael W Konstan

    Case Western Reserve University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
FED

Study Record Dates

First Submitted

October 18, 1999

First Posted

October 19, 1999

Study Start

August 1, 1996

Study Completion

June 1, 1999

Last Updated

March 25, 2015

Record last verified: 2000-04