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Targeting Pro-Inflammatory Cells in Idiopathic Pulmonary Fibrosis: a Human Trial

Study Purpose

The purpose of this study is to determine whether dasatinib and quercetin can reduce the expression of pro-inflammatory cells obtained by skin biopsy.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 50 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. Men between ages 50 and above, at the time of signing the informed consent. 2. Post-menopausal women ages 50 and above, at the time of signing the informed consent. Note: Postmenopausal is defined as 12 months of spontaneous amenorrhea determined by self-report. 3. A clinical diagnosis of IPF and characteristic chest HRCT scan (determined by panel of pulmonary radiologists) OR biopsy showing usual interstitial pneumonia (UIP). 4. Body Mass Index (BMI) within the range 19
  • - 39.9 kg/ m2 (inclusive), where BMI = (weight in kg) / (height in meters)2 .
5. Subjects participating in an exercise program must be willing to maintain their current activity level for the duration of the study period. 6. Patients on stable therapy with nintedanib (Ofev) or pirfenidone (Esbriet) over the past 3 months.ORPatients not taking nintedanib (Ofev) or pirfenidone (Esbriet) may be enrolled if they have previously not tolerated one of those medications or if those medications have not yet been prescribed or used by the patient. 7. Giving signed informed consent. 8. No plans to travel over the next 6 weeks.

Exclusion Criteria:

1. More than two moderate/severe IPF exacerbations within the past year Exacerbation is defined as worsening of two or more of the following major symptoms: dyspnea, sputum volume, sputum purulence OR worsening of any one major symptom together with at least one of the following additional symptoms: sore throat, colds (nasal discharge and/or nasal congestion), fever > 37.5 ° C without any explained cause, increased cough, increase wheeze. A moderate exacerbation is defined as an event that is associated with a new prescription for antibiotics and/or oral steroids. A severe exacerbation is defined as an event that is associated with hospitalization or emergency room visit. 2. Any moderate/severe IPF exacerbation within the past 4 weeks. 3. History of a lung transplant. 4. Use of anti-arrhythmic medications known to cause QTc prolongation. 5. Pulmonary hypertension or cor pulmonale confirmed by echocardiography or heart catheterization. 6. Myocardial infarction, angina, hospitalization for cardiac aetiology, stroke or transient ischemic attack in the past 6 months. 7. Chronic heart failure. 8. Neurologic, musculoskeletal, or other condition that in the opinion of the study physician limits subject's ability to complete study physical assessments. 9. Uncontrolled diabetes (HbA1c > 8% and fasting glucose >200 mg/dL or the current use of insulin). 10. Subjects with values outside the specified ranges for the following Key Clinical Laboratory Tests must be excluded from the study: Renal function: Glomerular Filtration Rate (GFR) <30 (mL/min/1.73 m2) using formulae provided in the Study Reference Manual (SRM). Note: Subjects receiving dialysis are excluded from this study. ALT >2xULN and bilirubin >1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%). 11. Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones). 12. QTcB or QTcF > 450 msec or QTc > 480 msec in subjects with Bundle Branch Block based on a single ECG. 13. Subjects with a history of malignancy that is not in complete remission for at least 2 years or 1 year for non-melanoma skin carcinoma. 14. The subject has participated in a clinical trial and has received an investigational product within the following time period prior to participation in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer). 15. History of drug or alcohol abuse within 5 years prior to randomization. 16. Use of Coumadin or other anti-platelet or anti-coagulant medication. The use of aspirin is permitted. 17. Current use of quinolone antibiotics. 18. Low CBC. 19. Cognitive Impairment (MoCA score less than 21) 20. Other medical or behavioral factors that in the judgment of the principal investigator may interfere with study participation or the ability to follow the intervention

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT02874989
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Wake Forest University Health Sciences
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Stephen Kritchevsky, PhD
Principal Investigator Affiliation Wake Forest Univerisity Health Sciences
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Idiopathic Pulmonary Fibrosis (IPF)

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Wake Forest Baptist Health, Winston-Salem, North Carolina

Status

Active, not recruiting

Address

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157

San Antonio, Texas

Status

Recruiting

Address

University of Texas Health Science Center

San Antonio, Texas, 78245

Site Contact

Che Kelly

che@uthscsa.edu

210-949-3898