Cystic FibrosisNCT00322868

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

A study testing pioglitazone in people with Cystic Fibrosis, run by University Hospitals Cleveland Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cystic Fibrosis
What is being tested?: pioglitazone
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 21 participants
Where: 1 siteUnited States
Study dates: Apr 2006to Apr 2007
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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%

Show all 14Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Rainbow Babies and Children's Hospital
Cleveland, Ohio, 44106

Other trials in United States

About this study

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 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.

Read the 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

Conditions: Cystic Fibrosis
Being tested: pioglitazone
Keywords: Prescription drugs, Administration, oral, Durable medical equipment, Kinetics
Medical subject headings: Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

pioglitazoneDrug
Also called Actos, Takeda
All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily.

Study groups in NCT00322868
Study group	Role	What they receive
Pioglitazone	Experimental	All subjects treated for 28 days with pioglitazone, 30 mg orally, once daily Other names: Actos, Takeda Receives: Drug: pioglitazone

What is being measured

The primary outcome is the main question the study is designed to answer.

Sputum White Cell Count
The total number of white cells log 10 cells/mL
Measured: Day 0 and Day 29
Sputum Neutrophil Count
sputum neutrophils log 10 (cells/mL)
Measured: Day 0 and Day 29
Sputum Neutrophil Percent
Neutrophils as a percent of the total white cells.
Measured: Day 0 and Day 29
Sputum Active Elastase
Log 10 of Concentration of active Elastase in mcg/mL
Measured: Day 0 and Day 29
Sputum TNFα
The concentration of Tumor Necrosis Factor-α (TNFα) log 10 (pg/mL)
Measured: Day 0 and Day 29
Sputum IL-1ß
The concentration of Interleukin-1ß (IL-1ß) log 10 (pg/mL)
Measured: Day 0 and Day 29
Sputum IL-6
The concentration of Interleukin-6 (IL-6) log 10 (pg/mL)
Measured: Day 0 and Day 29
Sputum IL-8
Concentration of Interleukin-8 log 10 (pg/mL)
Measured: Day 0 and Day 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2006Apr 2007

First posted8 May 2006 (estimated)
Study startApr 2006
Primary completionDec 2006
Study completionApr 2007

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Cystic FibrosisStudies of the same condition, open and under way.
More trials run by University Hospitals Cleveland Medical CenterThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 21 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00322868
Sponsor's protocol ID: CFFTI-Pio001
Status last verified: Feb 2018
First submitted: 4 May 2006
Last updated: 23 Feb 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Individualized personal data (IPD) will not be shared

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
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Active, not recruitingObservational study
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RecruitingObservational study
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RecruitingPhase 2
Early Study on Tamoxifen Safety/Tolerability in Cystic Fibrosis Patients Unable to Use CFTR Modulators.
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All Cystic Fibrosis trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00322868
Acronym / sponsor ID: CFFTI-Pio001
Conditions: Cystic Fibrosis
Keywords: Prescription drugs, Administration, oral, Durable medical equipment, Kinetics
Study type: Interventional
Recruitment status: Completed
Enrolment: 21 participants (actual)
Lead sponsor: University Hospitals Cleveland Medical CenterUniversity, hospital or other
Collaborators: Cystic Fibrosis Foundation
Study start: Apr 2006
Primary completion: Dec 2006 (actual)
Study completion: Apr 2007 (actual)
First posted: 8 May 2006 (estimated)
Results: Posted 23 Feb 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study Hypothesis: Pioglitazone may decrease inflammation in cystic fibrosis lung disease.

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 design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pioglitazone	Experimental	Drug: pioglitazoneAll subjects treated for 28 days with pioglitazone, 30 mg orally, once daily Other names: Actos, Takeda

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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

Key exclusion criteria (14 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
pioglitazoneAlso: Actos, TakedaAll subjects treated for 28 days with pioglitazone, 30 mg orally, once daily.	Drug	Pioglitazone

Primary outcome

Sputum White Cell Count
Time frame: Day 0 and Day 29
The total number of white cells log 10 cells/mL
Sputum Neutrophil Count
Time frame: Day 0 and Day 29
sputum neutrophils log 10 (cells/mL)
Sputum Neutrophil Percent
Time frame: Day 0 and Day 29
Neutrophils as a percent of the total white cells.
Sputum Active Elastase
Time frame: Day 0 and Day 29
Log 10 of Concentration of active Elastase in mcg/mL
Sputum TNFα
Time frame: Day 0 and Day 29
The concentration of Tumor Necrosis Factor-α (TNFα) log 10 (pg/mL)
Sputum IL-1ß
Time frame: Day 0 and Day 29
The concentration of Interleukin-1ß (IL-1ß) log 10 (pg/mL)
Sputum IL-6
Time frame: Day 0 and Day 29
The concentration of Interleukin-6 (IL-6) log 10 (pg/mL)
Sputum IL-8
Time frame: Day 0 and Day 29
Concentration of Interleukin-8 log 10 (pg/mL)

Results and safety

Results posted to the registry on 23 Feb 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Pioglitazone (30 mg)	21	20

Primary outcome: Sputum White Cell Count

Time frame: Day 0 and Day 29. Mean (Standard Deviation). Unit: log 10 (cells/mL)

Measure	Baseline n = 19	Post-Treatment n = 19
Value	6.93 (0.40)	6.81 (0.41)

Baseline vs Post-Treatment: p = 0.2772, t-test, 1 sided

Population analysed: 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.

Primary outcome: Sputum Neutrophil Count

Time frame: Day 0 and Day 29. Mean (Standard Deviation). Unit: log 10 (cells/mL)

Measure	Baseline n = 19	Post-Treatment n = 19
Value	6.88 (0.39)	6.75 (0.42)

Baseline vs Post-Treatment: p = 0.2467, t-test, 1 sided

Primary outcome: Sputum Neutrophil Percent

Time frame: Day 0 and Day 29. Mean (Standard Deviation). Unit: Percent (%) of white blood cells

Measure	Baseline n = 19	Post-Treatment n = 19
Value	82.47 (11.88)	74.44 (17.07)

Baseline vs Post-Treatment: p = 0.0288, t-test, 1 sided

Primary outcome: Sputum Active Elastase

Time frame: Day 0 and Day 29. Mean (Standard Deviation). Unit: log 10 (mcg/mL)

Measure	Baseline n = 19	Post-Treatment n = 19
Value	2.03 (0.36)	1.96 (0.36)

Baseline vs Post-Treatment: p = 0.50, t-test, 1 sided

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Pioglitazone (30 mg)	0 of 20 (0%)	1 of 20 (5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Individualized personal data (IPD) will not be shared

Related trials for Cystic Fibrosis

RecruitingPhase 2
A Study of 24 to 52 Weeks Treatment to Evaluate The Efficacy And Safety of Galvokimig in Adult Study Participants With Non-Cystic Fibrosis Bronchiectasis
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Active, not recruitingObservational study
CFTR Modulator Effects on Bone and Muscle in Adults With Cystic Fibrosis
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Michael W. Konstan, MD principal investigator

Case University and Rainbow Babies and Children's Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing pioglitazone in people with Cystic Fibrosis, run by University Hospitals Cleveland Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Sputum White Cell Count (time frame: Day 0 and Day 29). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00322868.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.