Is NCT05571059 recruiting in Miami, FL?

Yes, NCT05571059 is currently recruiting participants at its Miami, FL location. This idiopathic pulmonary fibrosis clinical trial is actively enrolling qualified participants.

How do I join the idiopathic pulmonary fibrosis clinical trial in Miami?

To join this clinical trial in Miami, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Miami clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Idiopathic Pulmonary Fibrosis Clinical Trial in Miami, FL

Who Can Participate

Inclusion Criteria

Male or female age 40 years or older

IPF Diagnosis:

Satisfying the 2022 American Thoracic Society/European Respiratory Society /Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) diagnostic criteria (Raghu 2022) confirmed by the investigator

UIP or probable UIP based on chest HRCT obtained within 2 months of Day 0, or historical lung biopsy consistent with UIP.

If receiving antifibrotic therapy, patients must be receiving a stable dose for ≥ 4 months prior to Day 0 and planning to stay on stable background therapy. Allowable antifibrotic therapy includes: pirfenidone, nintedanib, nerandomilast, pirfenidone with nerandomilast, or nintedanib with nerandomilast (combination of pirfenidone and nintedanib not allowed). If not receiving antifibrotic therapy, patients must be naive to each drug (pirfenidone, nintedanib, nerandomilast) or not have received either for at least 4 weeks prior to Day 0 and remain off background therapy with no intention to start or re-start. Changes in antifibrotic therapy are not allowed on study.

If receiving monotherapy for the treatment of pulmonary hypertension (e.g. phosphodiesterase 5 inhibitors, endothelin receptor antagonists or inhaled or oral prostanoid therapy), patients must be receiving a stable dose for ≥ 4 weeks prior to Day 0 and planning to remain on a stable dose throughout the study.

FVC ≥ 40% of predicted normal according to Global Lung Initiative (GLI)

Diffusion Capacity of Carbon Monoxide (DLCO) \[corrected for hemoglobin\] ≥ 25% to \<80% of predicted normal

Exclusion Criteria

Relevant airways obstruction (pre-bronchodilator Forced Expiratory Volume in one second to forced vital capacity ratio less than 70% (FEV1/FVC \< 0.7))

In the opinion of the Investigator, other clinically significant pulmonary abnormalities.

Known significant PAH, defined as previous clinical or echocardiographic evidence of significant right heart failure, history of right heart catheterization showing a cardiac index \< 2 L/min/m2, or PAH requiring combination of PAH-specific therapies or any PAH parenteral therapy.

Emphysema ≥ 50% on HRCT assessed by the investigator, or the extent of emphysema is greater than the extent of fibrosis according to reported results from the most recent chest HRCT.

Acute IPF exacerbation within 6 weeks prior to screening and/or during the screening period (investigator-determined).

ILD associated with other known causes

Lower respiratory tract infection requiring antibiotics within 4 weeks prior to Day 0 and/or during the screening period.

Major surgery (major according to the investigator's assessment) performed within six weeks prior to Day 0 or planned during the course of the trial. (Being on a transplant list is allowed).

AST or ALT \> 1.5 x ULN, Bilirubin \> 1.5 x ULN, Creatinine clearance \< 30 mL/min calculated by Cockcroft-Gault formula.

Underlying chronic liver disease (Child Pugh A, B or C hepatic impairment).

Cardiovascular diseases, any of the following:

Severe hypertension, uncontrolled despite treatment (≥160/100 mmHg)

Myocardial infarction within 6 months of Day 0

Unstable cardiac angina

Bleeding risk, any of the following:

Known genetic predisposition to bleeding.

Patients who require: i. Fibrinolysis, full-dose therapeutic anticoagulation (e.g. vitamin K antagonists, direct thrombin inhibitors, direct oral anticoagulants, heparin, hirudin) ii. High dose antiplatelet therapy (\> 325 mg/day of aspirin; \> 75 mg/day ticlodipine or clopidogrel; any dose of other 2b3a anti-platelet agents)

History of hemorrhagic central nervous system (CNS) event within 12 months of Day 0

Any of the following within 3 months of Day 0:

Hemoptysis or hematuria

Active gastro-intestinal (GI) bleeding needing hospitalization/intervention or peptic ulcer disease

Coagulation parameters: International normalized ratio (INR) \>2, prolongation of prothrombin time (PT) and activated partial thromboplastin time (aPTT) by \>1.5 x ULN Note: Prophylactic low dose heparin or heparin flush as needed for maintenance of an indwelling intravenous device (e.g. less than or equal to enoxaparin 40 mg subcutaneously (SC) per day or heparin 5000 units SC every eight hours), low-dose FXa inhibitors (rivaroxaban/apixaban: 2.5mg twice daily (max 5mg/day), edoxaban: 15mg/day), as well as prophylactic use of antiplatelet therapy (e.g. acetyl salicylic acid \[ASA\] up to 325 mg/day, or clopidogrel at 75 mg/day, or equivalent doses of other antiplatelet therapy) are not prohibited.

History of thrombotic event (including stroke and transient ischemic attack) within 12 months of Day 0

Use of disease-modifying antirheumatic drugs, B-cell depleting therapies or immunosuppressive medications, within 6 months of Day 0.

Use of systemic corticosteroids equivalent to prednisone \>15mg/day within 2 weeks of Day 0.

Simultaneous use of pirfenidone and nintedanib at screening.

Other disease that may interfere with testing procedures or in the judgment of the Investigator may interfere with trial participation or may put the patient at risk when participating in this trial.

Any documented active or suspected malignancy within 5 years prior to Day 0, except appropriately treated basal cell carcinoma of the skin, in situ squamous cell carcinoma of the skin or "under surveillance" prostate cancer.

Evidence of active infection (chronic or acute) based on clinical exam or laboratory findings.

The patient has a confirmed infection with Severe Acute Respiratory Syndrome- Coronvirus-2 (SARS-CoV-2) within the four weeks prior to Day 0 or during the screening period.

Women who are pregnant, nursing, or who plan to become pregnant while in the trial.

Women of childbearing potential not willing or able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently for 28 days prior to and three months after Investigational Medicinal Product (IMP) administration. Note: A woman is considered of childbearing potential, i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy

In the opinion of the Investigator, active alcohol or drug abuse.

Patients not able to understand or follow trial procedures including completion of self- administered questionnaires without help.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Miami?

Yes, this clinical trial (NCT05571059) has an active research site in Miami, FL that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Idiopathic Pulmonary Fibrosis Treatment Options in Miami, FL

If you're searching for idiopathic pulmonary fibrosis treatment options in Miami, FL, this clinical trial (NCT05571059) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Miami research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced idiopathic pulmonary fibrosis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all idiopathic pulmonary fibrosis clinical trials near you to find additional studies recruiting in your area.

Idiopathic Pulmonary Fibrosis Clinical Trial in Miami, FL

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About This Idiopathic Pulmonary Fibrosis Study in Miami