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

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ClinicalTrials.gov Identifier: NCT00322868
Recruitment Status : Completed
First Posted : May 8, 2006
Results First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Collaborator:
Cystic Fibrosis Foundation Therapeutics
Information provided by (Responsible Party):
Michael W. Konstan, University Hospitals Cleveland Medical Center

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.


Condition or disease Intervention/treatment Phase
Cystic Fibrosis Drug: pioglitazone Not Applicable

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description: This was open-label and no one was masked.
Primary Purpose: Treatment
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 Start Date : April 2006
Actual Primary Completion Date : December 2006
Actual Study Completion Date : April 2007


Arm Intervention/treatment
Experimental: Pioglitazone
All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily Other names: Actos, Takeda
Drug: pioglitazone
All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily.
Other Names:
  • Actos
  • Takeda




Primary Outcome Measures :
  1. Sputum White Cell Count [ Time Frame: Day 0 and Day 29 ]
    The total number of white cells log 10 cells/mL

  2. Sputum Neutrophil Count [ Time Frame: Day 0 and Day 29 ]
    sputum neutrophils log 10 (cells/mL)

  3. Sputum Neutrophil Percent [ Time Frame: Day 0 and Day 29 ]
    Neutrophils as a percent of the total white cells.

  4. Sputum Active Elastase [ Time Frame: Day 0 and Day 29 ]
    Log 10 of Concentration of active Elastase in mcg/mL

  5. Sputum TNFα [ Time Frame: Day 0 and Day 29 ]
    The concentration of Tumor Necrosis Factor-α (TNFα) log 10 (pg/mL)

  6. Sputum IL-1ß [ Time Frame: Day 0 and Day 29 ]
    The concentration of Interleukin-1ß (IL-1ß) log 10 (pg/mL)

  7. Sputum IL-6 [ Time Frame: Day 0 and Day 29 ]
    The concentration of Interleukin-6 (IL-6) log 10 (pg/mL)

  8. Sputum IL-8 [ Time Frame: Day 0 and Day 29 ]
    Concentration of Interleukin-8 log 10 (pg/mL)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00322868


Locations
United States, Ohio
Rainbow Babies and Children's Hospital
Cleveland, Ohio, United States, 44106
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Cystic Fibrosis Foundation Therapeutics
Investigators
Principal Investigator: Michael W. Konstan, MD Case University and Rainbow Babies and Children's Hospital

Responsible Party: Michael W. Konstan, Professor of Pediatrics, University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT00322868     History of Changes
Other Study ID Numbers: CFFTI-Pio001
First Posted: May 8, 2006    Key Record Dates
Results First Posted: February 23, 2018
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Individualized personal data (IPD) will not be shared

Keywords provided by Michael W. Konstan, University Hospitals Cleveland Medical Center:
Prescription drugs
Administration, oral
Durable medical equipment
Kinetics

Additional relevant MeSH terms:
Fibrosis
Cystic Fibrosis
Lung Diseases
Pathologic Processes
Pancreatic Diseases
Digestive System Diseases
Respiratory Tract Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
Pioglitazone
Anti-Inflammatory Agents
Hypoglycemic Agents
Physiological Effects of Drugs