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INFORMATION FOR PATIENTS

In 1998, researchers at UCLA started the first human studies to test all-trans retinoic acid as a medical treatment for emphysema (the UCLA ATRA Emphysema Study).  20 individuals with moderately severe or severe emphysema were treated with a three month course of medication.  The treatment was well tolerated and several individuals reported an improved sense of breathing.  Results from pulmonary function tests, CT scans and blood tests obtained during the treatment are still being evaluated.  

The FORTE Study will continue the testing of retinoids as an experimental treatment for emphysema.  FORTE will test different drugs and dose levels for their safety and effectiveness, and will develop procedures to detect whether retinoic acids have beneficial effects.  If results from the FORTE study indicate that such treatment may help people with emphysema, a larger clinical study of retinoid therapy for emphysema may be launched in the future.

Developed and funded through the National Heart, Lung and Blood Institute of the National Institutes of Health, the FORTE Study will enroll a total of 300 emphysema patients at 5 clinical centers across the country (60 patients at each site):

  • UCLA School of Medicine
  • UC San Diego School of Medicine
  • Boston University School of Medicine
  • Columbia University and Long Island Jewish Medical Center
  • University of Pittsburgh.

 
Purpose and Approach to the FORTE Study:

Establish the effectiveness of all-trans-retinoic acid (ATRA) or 13-cis-retinoic acid (cRA) in the treatment of patients with advanced emphysema.

To determine if the medication is safe to take by people that have emphysema.

Patients with mild to moderately severe emphysema will be treated for 6 months with either ATRA at the same dose used in the original UCLA ATRA Emphysema Study, twice the dose of ATRA, 13-cis retinoic acid (cRA) as an alternative retinoid medication, or a placebo pill which does not contain any medication.  After 6 months, individuals will be switched so that those who initially received ATRA or cRA will receive 3 months of the placebo, and those who initially received placebo will be treated with one of the retinoid medications for 3 months.  In this manner, every patient that participates in the study will be treated with at least 3 months of retinoid medication and most will be treated with 6 months of medication.  The study will be randomized and blinded, meaning that neither the patients or the physicians will know which type of medication is being taken at any given time.

Medications to be tested

1. Low dose all-trans retinoic acid
2. High dose all-trans retinoic acid
3. 13-cis retinoic acid
4. Placebo - which contains no medication

Duration of study

9 months total, 6 months on one treatment (active drug or placebo) and 3 months on the alternative treatment (placebo or active drug).

Eligibility criteria

In order to be eligible for the study, patients must meet a variety of eligibility criteria.  The basic characteristics are described below:

Men and women 45 years of age or older
Mild to moderate emphysema as determined by pulmonary function tests
CT scan evidence of emphysema

Required visits and monitoring

In order to participate in the FORTE Study at UCLA, individuals will be asked to send medical information to UCLA for review.  After an initial review of this information, potential candidates will be invited to UCLA for a complete screening and evaluation.  Eligibility for the study will be based on the exams and testing performed at UCLA.

If invited to join the study, and if individuals provide their written consent after being informed of the procedures and potential risks, baseline tests will be done to assess their lungs and they will be started on medication.  Baseline testing will include the following:

  • complete pulmonary function tests in which patients inhale and exhale into a machine to measure the extent of their breathing capacity.
  • chest CT scans - computerized x-rays to accurately map lung damage.
  • bronchoscopy tests in which a small flexible tube is passed through the mouth and into the lungs in order to collect lung samples for laboratory testing.
  • questionnaires to assess quality of life and the degree of respiratory symptoms.
  • physical exams and blood work to monitor health and detect any toxicity
  • These tests will be repeated on one or more occasions during the study and monthly visits to UCLA will be required for the entire 9 months of the study.  An extra visit at either 2 weeks into the study, or after 4 months of treatment, will be required in order to undergo a second bronchoscopy test.

Financial Obligations and Compensation

You or your third party insurance payer will be financially responsible for the costs of the initial screening/consultation visit.  All tests and subsequent follow up visits which are being specifically performed to evaluate your response to the study protocol will be provided free of charge. The study pills and the costs involved in providing them for your use will also be provided free of charge.

It is possible that your insurance will not pay for the initial screening visit. That is because many insurance companies, HMOs and health benefit plans do not cover experimental treatments.  If that happens, you will be responsible for the cost of the initial screening consultation. You are entitled to receive an estimate of the cost associated with this study before you enroll.

Your will be eligible for up to a maximum of $500 in compensation for the time and effort that you put forth to participate in the study. If you are injured as a direct result of research procedures not done primarily for your own benefit, you will receive treatment at no cost.  The University of California does not provide any other form of compensation for injury.

How to find out more information or to enroll at UCLA

Individuals interested in more information, or in being screened for the study, should contact the UCLA FORTE Study Coordinators by phone, FAX or email as detailed in the "CONTACT US" section.  Individuals interested in participating at other sites should contact the center closest to them as listed under the "STUDY CENTERS" section.

The material presented on this website pertain to participation at the UCLA site only - different policies, testing and procedures may exist at other sites involved in the FORTE Study.