Cycled Testosterone Administration During Pulmonary Rehabilitation in COPD Patients
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Chronic Obstructive Pulmonary Disease |
| Therapuetic Areas: | Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 50 - Any |
| Updated: | 11/11/2018 |
| Start Date: | December 1, 2019 |
| End Date: | October 1, 2020 |
| Contact: | Lichar Dillon, PhD |
| Email: | eldillon@utmb.edu |
| Phone: | 409-772-8701 |
Chronic obstructive pulmonary disease (COPD) involves chronic inflammation of the airways
and/or damage to the lungs and leads to progressive impairments in airflow and the ability to
breathe. COPD affects somewhere between 6 to 20% of the US population and is among the
leading causes for mortality in men and women. Although it remains unclear whether sex
determines survival, COPD has become an increasing concern among women. Recent long-term
investigations revealed that women scored lower on health status questionnaires, displayed
worse dyspnea scores, and experienced more exacerbations than men.
The overall goal is to provide an effective long-term treatment strategy that prevents the
advancement of COPD in women through a safe, cycled administration of testosterone. The
general hypothesis is that cycled testosterone treatment is safe and effective at reducing
smooth muscle inflammation & catabolism and protects pulmonary function in patients with COPD
undergoing pulmonary rehabilitation. This pilot study will assess the impact over a standard
12-week pulmonary rehabilitation program of cycling testosterone treatment. If the pilot is
promising, longer-term studies will be developed to determine whether cycling testosterone
treatment can slow the progression of COPD in women. The study team are experts in pulmonary
care, endocrinology, and muscle physiology and are poised to address the problem in
(non-sarcopenic/non-cachectic) female COPD patients enrolling in an established pulmonary
rehabilitation program.
and/or damage to the lungs and leads to progressive impairments in airflow and the ability to
breathe. COPD affects somewhere between 6 to 20% of the US population and is among the
leading causes for mortality in men and women. Although it remains unclear whether sex
determines survival, COPD has become an increasing concern among women. Recent long-term
investigations revealed that women scored lower on health status questionnaires, displayed
worse dyspnea scores, and experienced more exacerbations than men.
The overall goal is to provide an effective long-term treatment strategy that prevents the
advancement of COPD in women through a safe, cycled administration of testosterone. The
general hypothesis is that cycled testosterone treatment is safe and effective at reducing
smooth muscle inflammation & catabolism and protects pulmonary function in patients with COPD
undergoing pulmonary rehabilitation. This pilot study will assess the impact over a standard
12-week pulmonary rehabilitation program of cycling testosterone treatment. If the pilot is
promising, longer-term studies will be developed to determine whether cycling testosterone
treatment can slow the progression of COPD in women. The study team are experts in pulmonary
care, endocrinology, and muscle physiology and are poised to address the problem in
(non-sarcopenic/non-cachectic) female COPD patients enrolling in an established pulmonary
rehabilitation program.
Female COPD patients participating in a 12 week pulmonary rehabilitation program at the
University of Texas Medical Branch recruited in the study will be randomized into either
placebo or testosterone enanthate (25mg) treatment. Testosterone and placebo will be given in
a cyclic fashion during the pulmonary rehab with single injections given on weeks 2, 3, 6, 7,
10 and 11. Pre (during week 1) and post (during week 12) study testing will measure the
effectiveness of testosterone on several measures listed in the outcome section.
University of Texas Medical Branch recruited in the study will be randomized into either
placebo or testosterone enanthate (25mg) treatment. Testosterone and placebo will be given in
a cyclic fashion during the pulmonary rehab with single injections given on weeks 2, 3, 6, 7,
10 and 11. Pre (during week 1) and post (during week 12) study testing will measure the
effectiveness of testosterone on several measures listed in the outcome section.
Inclusion Criteria:
1. Female
2. BMI between 20 and 28
3. Stable weight (<10 lbs change in past 12 months)
4. (Willing to) participate in pulmonary rehab (PR) program at UTMB
5. Air flow limitation based on spirometry (FEV1 less than 60% predicted) (prior to PR)
6. Daily symptoms according to COPD assessment test (CAT) > 15 (prior to PR)
7. At least 1 exacerbation leading to emergency department, urgent care, or
hospitalization in past 6 months
8. Aged > 50 years
Exclusion Criteria:
1. Late stage COPD, GOLD Stage 3-4 (FEV1 > 60% predicted).
2. Inability to perform 6-minute walking test or other physical therapy activities.
3. Inability/unwillingness to follow the pulmonary rehabilitation program.
4. Already more than 2 weeks into the pulmonary rehabilitation program at time of
consenting.
5. Diagnosed with carcinomas of the breast.
6. Diagnosed with chronic heart failure (CHF).
7. Uncontrolled endocrine or metabolic disease (e.g. liver disease, renal disease,
diabetes).
8. Uncontrolled hypertension. Systolic blood pressure greater than 160mm Hg or a
diastolic blood pressure greater than 100mm Hg on three consecutive measurements taken
at one-week intervals. Testosterone can cause fluid retention that could worsen
uncontrolled hypertension.
9. History of significant liver disorders or a 3-fold elevation of liver function tests
(Alk phos, ALT, AST). Testosterone can have hepatotoxic effects in some subjects and
should be used with careful monitoring of LFTs (liver function), though injections of
testosterone at a 25 mg dose is not typically sufficient to negatively affect LFTs.
10. History of angina that occurs with exertion or at rest or a myocardial infarction
within the last 12 months.
11. LDL cholesterol greater than 200 mg/dL as testosterone administration may elevate LDL
cholesterol levels further, though this is not anticipated with testosterone treatment
of 25 mg/injection.
12. Hematocrit greater than 51%.
13. Current abuse of alcohol or drugs.
14. Any other condition or event considered exclusionary by the PI and covering faculty
physician
15. Vulnerable populations including: individuals unable to consent on their own behalf,
prisoners and pregnant women.
We found this trial at
1
site
301 University Blvd
Galveston, Texas 77555
Galveston, Texas 77555
(409) 772-1011
Principal Investigator: Randall J Urban, MD
Phone: 409-223-7891
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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