Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2025-12-24 @ 2:22 PM
NCT ID:
NCT00219895
Eligibility Criteria:
Inclusion Criteria:
* Male or female 10 years of age or older.
* Confirmed diagnosis of CF based on the following criteria:
* positive sweat chloride \>= 60 mEq/liter (by pilocarpine iontophoresis) and/or
* a genotype with two identifiable mutations consistent with CF, and
* accompanied by one or more clinical features consistent with the CF phenotype
* FEV1 \>= 50% predicted value (subjects \>= 10 - \<18 years of age) or \>= 40% predicted value (subjects \>= 18 years of age)
* Clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation within the 14 days prior to Visit 1 (Day 0)
* Ability to reproducibly perform spirometry and peak flow measurements
* Ability to understand and sign a written informed consent or assent and comply with the requirements of the study
Exclusion Criteria:
* Use of an investigational agent within the 4-week period prior to Visit 1 (Day 0)
* Chronic daily use of ibuprofen, celecoxib, or other selective COX-2 inhibitors, other NSAIDs, or systemic or inhaled corticosteroids within the 4 weeks prior to Visit 1 (Day 0) or acute usage within 72 hours prior to Visit 1 (Day 0)
* History of hypersensitivity to beta-agonists
* History of hypersensitivity to sulfonamides, aspirin, or other NSAIDs
* Oxygen saturation \< 92% on room air at Visit 1 (Day 0)
* Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
* History of hemoptysis \>= 30 cc per episode during the 30 days prior to Visit 1 (Day 0)
* Significant history of hepatic, cardiovascular, renal, neurological, hematologic, or peptic ulcer disease
* SGOT (ALT) or SGPT (AST) \> 3 times the upper limit of normal at screening, documented biliary cirrhosis, or portal hypertension
* Creatinine \> 1.8 mg/dL at screening
* Inability to swallow pills
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the subject or the quality of the data
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Study:
NCT00219895
Study Brief:
Protocol Section:
NCT00219895