Safety and Efficacy of Pioglitazone as an Anti-inflammatory for the Treatment of Cystic Fibrosis (CF) Lung Disease

Cystic Fibrosis Clinical Trial

Official title:

A Pilot Study Assessing the Safety and Efficacy of Pioglitazone as an Anti-inflammatory Agent for the Treatment of CF Lung Disease in Patients With Cystic Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00322868
• Other study ID #: CFFTI-Pio001
• Status: Completed
• Phase: N/A
• First received: May 4, 2006
• Last updated: February 21, 2018
• Start date: April 2006
• Est. completion date: April 2007

Study information

• Verified date: February 2018
• Source: University Hospitals Cleveland Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

• Single-center, open label study of pioglitazone in clinically stable patients with mild to moderate CF lung disease

• Induced sputum will be obtained from each subject at enrollment (Baseline) and again following 28 days of pioglitazone treatment (End of Treatment)

• Changes in markers of inflammation in the sputum samples will be assessed

• Safety measures, including complete blood count (CBC), serum chemistry, Erythrocyte sedimentation rate (ESR), C-Reactive Protein (CRP), urinalysis and spirometry, will also be assessed

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: April 2007
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis
• Lung Diseases

Intervention

Drug:
• pioglitazone
All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily.

Locations

Country	Name	City	State
United States	Rainbow Babies and Children's Hospital	Cleveland	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
University Hospitals Cleveland Medical Center	Cystic Fibrosis Foundation Therapeutics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sputum White Cell Count	The total number of white cells log 10 cells/mL	Day 0 and Day 29
Primary	Sputum Neutrophil Count	sputum neutrophils log 10 (cells/mL)	Day 0 and Day 29
Primary	Sputum Neutrophil Percent	Neutrophils as a percent of the total white cells.	Day 0 and Day 29
Primary	Sputum Active Elastase	Log 10 of Concentration of active Elastase in mcg/mL	Day 0 and Day 29
Primary	Sputum TNFa	The concentration of Tumor Necrosis Factor-a (TNFa) log 10 (pg/mL)	Day 0 and Day 29
Primary	Sputum IL-1ß	The concentration of Interleukin-1ß (IL-1ß) log 10 (pg/mL)	Day 0 and Day 29
Primary	Sputum IL-6	The concentration of Interleukin-6 (IL-6) log 10 (pg/mL)	Day 0 and Day 29
Primary	Sputum IL-8	Concentration of Interleukin-8 log 10 (pg/mL)	Day 0 and Day 29