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Antibiotic

Minocycline Therapy for Idiopathic Pulmonary Fibrosis

Phase 3

Waitlist Available

Led By Eric Kleerup, MD

Research Sponsored by University of California, Los Angeles

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis must be made by high-resolution (HRCT) chest CT showing definite or probable IPF AND within 30 months prior to screening either of the following: Open or VATS lung biopsy showing definite or probable usual interstitial pneumonia (UIP), required for subjects ages 20-34 due to the rarity of IPF in this age group OR Non-diagnostic transbronchial biopsy to exclude other conditions (including granulomatous disease, sarcoidosis, hypersensitivity pneumonitis) AND abnormal pulmonary function tests (reduced FVC or decreased DLCO or impaired gas exchange at rest or during exercise) AND 2 of the following: Age > 50 years, Insidious onset of otherwise unexplained dyspnea on exertion, Bibasilar, inspiratory crackles (dry or Velcro type in character), Currently on low dose (< 0.3 mg/kg LBW) prednisone plus azathioprine or cyclophosphamide per ATS Consensus for at least 28 days prior to study treatment and intending to continue the same therapy until the end of study treatment. This therapy may be preceded by a course of higher-dose prednisone at the discretion of the treating physician, FVC > 40% and < 90% of predicted (Hankinson/NHANES2) value at screening, DLCO > 20% of predicted (Neas/NHANES3) value at screening, PaO2 > 50 mmHg at rest after 20 minutes on room air at baseline, Able to understand and sign a written informed consent form and comply with the requirements of the study

Clinical symptoms consistent with idiopathic pulmonary fibrosis (IPF) of > 3 months duration (insidious onset of otherwise unexplained dyspnea on exertion and bibasilar inspiratory crackles)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is investigating whether minocycline can help treat idiopathic pulmonary fibrosis (IPF), a chronic and fatal pulmonary disorder for which there is no FDA approved treatment. Minocycline is a semi synthetic derivative of tetracycline that was first marketed as an antibiotic in 1972.

Who is the study for?

This trial is for adults aged 20-79 with idiopathic pulmonary fibrosis (IPF), experiencing breathlessness and lung crackles, who have been on low-dose prednisone plus azathioprine or cyclophosphamide. They must have a certain level of lung function and not be on any investigational therapy recently. Exclusions include recent heart issues, infections, other causes of lung scarring, inability to follow the trial protocol, pregnancy, or significant blood or liver abnormalities.Check my eligibility

What is being tested?

The study tests Minocycline's potential as an add-on treatment for IPF by inhibiting abnormal blood vessel formation and preventing scar tissue in the lungs. It aims to see if this can stabilize or improve patients' conditions when added to their current regimen of steroids and immunosuppressants.See study design

What are the potential side effects?

Minocycline side effects may include lightheadedness, dizziness, vertigo, and changes in skin coloration. As it has been used mainly for treating infections like acne or sexually transmitted diseases before this trial, its specific impact on IPF patients will be closely monitored.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have had symptoms like shortness of breath and lung sounds for over 3 months.

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I am between 20 and 79 years old. If I'm 20-34, my lung condition was confirmed by a specific biopsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of California, Los AngelesLead Sponsor

1,528 Previous Clinical Trials

10,276,851 Total Patients Enrolled

1 Trials studying Idiopathic Pulmonary Fibrosis

Eric Kleerup, MDPrincipal InvestigatorUniversity of California, Los Angeles

Media Library

Minocycline (Antibiotic) Clinical Trial Eligibility Overview. Trial Name: NCT00203697 — Phase 3

Idiopathic Pulmonary Fibrosis Research Study Groups:

Idiopathic Pulmonary Fibrosis Clinical Trial 2023: Minocycline Highlights & Side Effects. Trial Name: NCT00203697 — Phase 3

Minocycline (Antibiotic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00203697 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the age limit for participants in this clinical trial extend to those under 80 years old?

"In order to apply to this clinical trial, patients must be between 20 and 79 years old. There are currently 83 studies underway for patients that are younger than 20 and 394 for patients older than 65."

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