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 @ 6:25 PM
Ignite Modification Date:
2025-12-24 @ 6:25 PM
NCT ID:
NCT00322868
Eligibility Criteria:
Inclusion Criteria:
* Male or female \>= 28 years of age
* Confirmed diagnosis of cystic fibrosis
* Forced Expiratory Volume in 1 second (FEV1) \>= 40% predicted
* Clinically stable
* Ability to reproduce spirometry
* Ability to understand and sign the informed consent
Exclusion Criteria:
* Use of an investigational agent within 4-week period prior to Visit 1
* Chronic daily use of ibuprofen or other NSAIDS
* Chronic daily use of insulin,oral diabetic agents or oral hypoglycemic agents
* History of hypersensitivity to beta agonists
* History of hypersensitivity to glitazones
* Oxygen saturation\<92%
* Pregnant, breastfeeding or unwilling to practice acceptable birth control
* History of hemoptysis \>30cc per episode within 30 days prior to Visit 1
* Significant history of hepatic, cardiovascular, renal,neurologic, hematologic or peptic ulcer disease
* Serum Glutamic-Oxaloacetic Transaminase (SGOT)/(Serum Glutamic Pyruvic Transaminase (SGPT) \>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 or abnormality that in the opinion of the investigator would compromise the safety or the quality of the data
* Subjects who have routinely taken ibuprofen or other NSAIDS; prednisone or other systemic corticosteroids, or insulin, or oral diabetic agents within 4 weeks prior to visit 1 or who have taken these medications as needed within 72 hours prior to visit one will be excluded
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00322868
Study Brief:
Protocol Section:
NCT00322868