N/A
N=21
Safety and Efficacy of Pioglitazone as an Anti-inflammatory for the Treatment of Cystic Fibrosis (CF) Lung Disease
Cystic Fibrosis
Bottom Line
View on ClinicalTrials.gov: NCT00322868 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Feb 2018
Primary outcome: Primary: Sputum White Cell Count — 6.93; 6.81 log 10 (cells/mL) — p=0.2772
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- pioglitazone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University Hospitals Cleveland Medical Center
- Primary completion
- Dec 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Sputum White Cell Count |
6.93; 6.81 | 0.2772 |
| PRIMARY Sputum Neutrophil Count |
6.88; 6.75 | 0.2467 |
| PRIMARY Sputum Neutrophil Percent |
82.47; 74.44 | 0.0288 sig |
| PRIMARY Sputum Active Elastase |
2.03; 1.96 | 0.50 |
| PRIMARY Sputum TNFα |
1.74; 1.69 | 0.62 |
| PRIMARY Sputum IL-1ß |
4.05; 3.99 | 0.50 |
| PRIMARY Sputum IL-6 |
1.38; 1.41 | 0.55 |
| PRIMARY Sputum IL-8 |
5.13; 5.10 | 0.75 |
Summary
Study Hypothesis: Pioglitazone may decrease inflammation in cystic fibrosis lung disease.
Primary outcomes: Markers of inflammation (neutrophils, elastase, cytokines and bacteria)will be measured in induced sputum specimens before and after a 4 week treatment period with pioglitazone in clinically stable CF patients.
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 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
Data sourced from ClinicalTrials.gov (NCT00322868). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.