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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pioglitazone
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring Prescription drugs, Administration, oral, Durable medical equipment, Kinetics

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Rainbow Babies and Children's Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pioglitazone

Arm Description

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

Outcomes

Primary Outcome Measures

Sputum White Cell Count
The total number of white cells log 10 cells/mL
Sputum Neutrophil Count
sputum neutrophils log 10 (cells/mL)
Sputum Neutrophil Percent
Neutrophils as a percent of the total white cells.
Sputum Active Elastase
Log 10 of Concentration of active Elastase in mcg/mL
Sputum TNFα
The concentration of Tumor Necrosis Factor-α (TNFα) log 10 (pg/mL)
Sputum IL-1ß
The concentration of Interleukin-1ß (IL-1ß) log 10 (pg/mL)
Sputum IL-6
The concentration of Interleukin-6 (IL-6) log 10 (pg/mL)
Sputum IL-8
Concentration of Interleukin-8 log 10 (pg/mL)

Secondary Outcome Measures

Full Information

First Posted
May 4, 2006
Last Updated
February 21, 2018
Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Cystic Fibrosis Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00322868
Brief Title
Safety and Efficacy of Pioglitazone as an Anti-inflammatory for the Treatment of Cystic Fibrosis (CF) Lung Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
April 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospitals Cleveland Medical Center
Collaborators
Cystic Fibrosis Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
Prescription drugs, Administration, oral, Durable medical equipment, Kinetics

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Masking Description
This was open-label and no one was masked.
Allocation
N/A
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pioglitazone
Arm Type
Experimental
Arm Description
All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily Other names: Actos, Takeda
Intervention Type
Drug
Intervention Name(s)
pioglitazone
Other Intervention Name(s)
Actos, Takeda
Intervention Description
All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily.
Primary Outcome Measure Information:
Title
Sputum White Cell Count
Description
The total number of white cells log 10 cells/mL
Time Frame
Day 0 and Day 29
Title
Sputum Neutrophil Count
Description
sputum neutrophils log 10 (cells/mL)
Time Frame
Day 0 and Day 29
Title
Sputum Neutrophil Percent
Description
Neutrophils as a percent of the total white cells.
Time Frame
Day 0 and Day 29
Title
Sputum Active Elastase
Description
Log 10 of Concentration of active Elastase in mcg/mL
Time Frame
Day 0 and Day 29
Title
Sputum TNFα
Description
The concentration of Tumor Necrosis Factor-α (TNFα) log 10 (pg/mL)
Time Frame
Day 0 and Day 29
Title
Sputum IL-1ß
Description
The concentration of Interleukin-1ß (IL-1ß) log 10 (pg/mL)
Time Frame
Day 0 and Day 29
Title
Sputum IL-6
Description
The concentration of Interleukin-6 (IL-6) log 10 (pg/mL)
Time Frame
Day 0 and Day 29
Title
Sputum IL-8
Description
Concentration of Interleukin-8 log 10 (pg/mL)
Time Frame
Day 0 and Day 29

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael W. Konstan, MD
Organizational Affiliation
Case University and Rainbow Babies and Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rainbow Babies and Children's Hospital
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individualized personal data (IPD) will not be shared

Learn more about this trial

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

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