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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00004440

Enrollment

Registered

1999-10-19

Start date

1996-08-31

Completion date

1999-06-30

Last updated

2015-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Keywords

cardiovascular and respiratory diseases, cystic fibrosis, genetic diseases and dysmorphic syndromes, rare disease

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.

Detailed description

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).

Interventions

DRUGibuprofen

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

5 Years to No maximum

Healthy volunteers

Yes

Inclusion 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026