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Completed

NCT Number: NCT00322868

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pioglitazone

Drug

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

Other names: Actos, Takeda

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Collaborators

  • Cystic Fibrosis Foundation

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2006
Study completion
2007
First posted
May 8, 2006
Registry last updated
Feb 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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