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

NCT00322868 | Completed Results

• 1 other identifier: CFFTI-Pio001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cystic Fibrosis

Keywords

Prescription drugs; Administration, oral; Durable medical equipment; Kinetics

Outcome Measures

Primary Outcomes (8)

• Sputum White Cell Count

  The total number of white cells log 10 cells/mL

  Day 0 and Day 29

• Sputum Neutrophil Count

  sputum neutrophils log 10 (cells/mL)

  Day 0 and Day 29

• Sputum Neutrophil Percent

  Neutrophils as a percent of the total white cells.

  Day 0 and Day 29

• Sputum Active Elastase

  Log 10 of Concentration of active Elastase in mcg/mL

  Day 0 and Day 29

• Sputum TNFα

  The concentration of Tumor Necrosis Factor-α (TNFα) log 10 (pg/mL)

  Day 0 and Day 29

• Sputum IL-1ß

  The concentration of Interleukin-1ß (IL-1ß) log 10 (pg/mL)

  Day 0 and Day 29

• Sputum IL-6

  The concentration of Interleukin-6 (IL-6) log 10 (pg/mL)

  Day 0 and Day 29

• Sputum IL-8

  Concentration of Interleukin-8 log 10 (pg/mL)

  Day 0 and Day 29

Study Arms (1)

Pioglitazone

EXPERIMENTAL

All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily Other names: Actos, Takeda

Drug: pioglitazone

Interventions

pioglitazone DRUG

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

Also known as: Actos, Takeda

Pioglitazone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead
• Cystic Fibrosis Foundation: collaborator

Study Sites (1)

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Michael W Konstan, MD
• Organization: Case Western Reserve University

michael.konstan@case.edu

2168443267

Study Officials

• Michael W. Konstan, MD

  Case University and Rainbow Babies and Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: This was open-label and no one was masked.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Pediatrics

Study Record Dates

• First Submitted: May 4, 2006
• First Posted: May 8, 2006
• Study Start: April 1, 2006
• Primary Completion: December 1, 2006
• Study Completion: April 1, 2007
• Last Updated: February 23, 2018
• Results First Posted: February 23, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)