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| Name | Class |
|---|---|
| Cystic Fibrosis Foundation | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pioglitazone | Experimental | All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily Other names: Actos, Takeda |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pioglitazone | Drug | All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael W. Konstan, MD | Case University and Rainbow Babies and Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rainbow Babies and Children's Hospital | Cleveland | Ohio | 44106 | United States |
Individualized personal data (IPD) will not be shared
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Washout: A 4 week washout from chronic use of NSAIDs, corticosteroids and oral meds to treat diabetes will be required. Subjects will be excluded if they take these medication within 72 hours of Visit 1. Subjects using alternate month tobramycin for inhalation (TOBI) will need to be on an off cycle to participate in this study.
All patients who will be approached for participation in this trial will first be identified using either Port CF (CFF Registry) or CF Center database. Once potentials are identified a chart review will be conducted to determine eligibility. Patients will approached at clinic for possible participation in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Pioglitazone (30 mg) | After screening eligibility requirements were met, cystic fibrosis subjects received pioglitazone orally, 30 mg, once daily, for 28 days |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
21 subjects were screened and enrolled with 1 subject withdrawal due to disease progression.
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| ID | Title | Description |
|---|---|---|
| BG000 | Pioglitazone (30 mg) | After screening eligibility requirements were met, cystic fibrosis subjects received pioglitazone orally, 30 mg, once daily, for 28 days |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | great or equal to 18 years of age |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Sputum White Cell Count | The total number of white cells log 10 cells/mL | Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples. | Posted | Mean | Standard Deviation | log 10 (cells/mL) | Day 0 and Day 29 |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pioglitazone (30 mg) | After screening eligibility requirements were met, cystic fibrosis subjects received pioglitazone orally,30 mg, once daily for 28 days |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypoglycemic event | Endocrine disorders | Systematic Assessment | Non serious, unexpected, possibly study related |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael W Konstan, MD | Case Western Reserve University | 2168443267 | michael.konstan@case.edu |
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| ID | Term |
|---|---|
| D003550 | Cystic Fibrosis |
| ID | Term |
|---|---|
| D010182 | Pancreatic Diseases |
| D004066 | Digestive System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D000077205 | Pioglitazone |
| ID | Term |
|---|---|
| D045162 | Thiazolidinediones |
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
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This was open-label and no one was masked.
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1 subject withdrawn due to disease progression
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | 1 subject was withdrawn and no samples analyzed | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | 1 subject withdrawn due to disease progression. no samples analyzed. | Count of Participants | Participants |
|
| Race (NIH/OMB) | 1 subject withdrawn due to disease progression no samples analyzed | Count of Participants | Participants |
|
| Region of Enrollment | 1 subject was withdrawn due to disease progression. No samples analyzed. | Count of Participants | Participants |
|
| Total white cell count | 1 subject withdrawn due to disease progression. No samples analyzed. | Mean | Standard Deviation | log 10 (cells/mL) |
|
| Total neutrophil count | 1 subject withdrawn due to disease progression. No samples analyzed. | Mean | Standard Deviation | Log 10 (PMN/mL) |
|
| percent neutrophils | 1 subject withdrawn due to disease progression. No samples analyzed | Mean | Standard Deviation | percent of white blood cells |
|
|
|
|
| Primary | Sputum Neutrophil Count | sputum neutrophils log 10 (cells/mL) | Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples. | Posted | Mean | Standard Deviation | log 10 (cells/mL) | Day 0 and Day 29 |
|
|
|
|
| Primary | Sputum Neutrophil Percent | Neutrophils as a percent of the total white cells. | Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples. | Posted | Mean | Standard Deviation | Percent (%) of white blood cells | Day 0 and Day 29 |
|
|
|
|
| Primary | Sputum Active Elastase | Log 10 of Concentration of active Elastase in mcg/mL | Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples. | Posted | Mean | Standard Deviation | log 10 (mcg/mL) | Day 0 and Day 29 |
|
|
|
|
| Primary | Sputum TNFα | The concentration of Tumor Necrosis Factor-α (TNFα) log 10 (pg/mL) | Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples. | Posted | Mean | Standard Deviation | log 10 (pg/mL) | Day 0 and Day 29 |
|
|
|
|
| Primary | Sputum IL-1ß | The concentration of Interleukin-1ß (IL-1ß) log 10 (pg/mL) | Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples. | Posted | Mean | Standard Deviation | log 10 (pg/mL) | Day 0 and Day 29 |
|
|
|
|
| Primary | Sputum IL-6 | The concentration of Interleukin-6 (IL-6) log 10 (pg/mL) | Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples. | Posted | Mean | Standard Deviation | log 10 (pg/mL) | Day 0 and Day 29 |
|
|
|
|
| Primary | Sputum IL-8 | Concentration of Interleukin-8 log 10 (pg/mL) | Of the 20 enrolled subjects, one did not produce sputum at Baseline and a second subject's Post-Treatment sputum sample was lost due to a lab error. This reduced the number of subjects per group to 19. Of these 19 subjects, 18 subjects had both Baseline and Post-Treatment sputum samples. | Posted | Mean | Standard Deviation | log 10 (pg/mL) | Day 0 and Day 29 |
|
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|
|
| 0 |
| 20 |
| 1 |
| 20 |
|
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| D030342 |
| Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007232 | Infant, Newborn, Diseases |
| D001393 |
| Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |