Clinical trial NCT03674320: Cycled Testosterone Administration During Pulmonary Rehabilitation in Early Stage COPD
Official title: Cycled Testosterone Administration During Pulmonary Rehabilitation in Early Stage COPD
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
PHASE3
Conditions: COPD
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2018-09-17
Enrollment: 0
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Chronic obstructive pulmonary disease (COPD) is characterized by chronic inflammation of the airways and/or damage to the lungs which leads to progressive impairment in airflow and the ability to breathe. COPD affects 6 to 20% of the US population and is among the leading causes for mortality in men and women. While COPD is principally a pathology of the airway, skeletal muscle wasting is a widely recognized comorbidity contributing to frequent and expensive hospital visits.

Hospital readmission rates among COPD patients are high and the majority of the readmissions are considered preventable. The reasons COPD patients lose muscle are still poorly understood although reduced pulmonary function has been associated with reduced testosterone levels. Muscle building treatments, including testosterone therapy, with and without exercise, have consistently been shown to promote improvements in body composition, exercise capacity, and health related quality of life of COPD patients.

The overall goal of this investigation is to provide an effective long-term treatment strategy that prevents the advancement of COPD in men and women through a safe, cycled administration of testosterone during the early stages of disease.

Detailed description: Male and female COPD patients participating in a 12 week pulmonary rehabilitation program at the University of Texas Medical Branch enrolled in the study will be randomized into either placebo or testosterone enanthate (100mg men, 25mg women) treatment. Testosterone and placebo will be given in a cyclic fashion during the pulmonary rehabilitation with single injections given on weeks 2, 3, 6, 7, 10 and 11. Baseline (during week 1 of rehabilitation) and post (during week 12 of rehabilitation) study testing will measure the effectiveness of testosterone on several measures listed in the outcome section.

Eligibility criteria: Inclusion Criteria:

1. Aged 40 - 80 years
2. Stable weight (\<10 lbs change in past 12 months - self reported)
3. (Willing to) participate in pulmonary rehabilitation (PR) program at UTMB
4. Air flow limitation based on spirometry (FEV1 \< 60% predicted) (prior to PR)
5. Daily symptoms according to COPD assessment test (CAT) \> 15 (prior to PR)

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. Uncontrolled endocrine or metabolic disease (e.g. liver disease, renal disease, diabetes)
6. Uncontrolled hypertension. Systolic blood pressure greater than or equal to 160mm Hg or a diastolic blood Pressure greater than or equal to 100mm Hg on three consecutive measurements taken at one-week intervals. Testosterone can cause fluid retention that could worsen uncontrolled hypertension. Subjects will be included if they are on two or less blood pressure medications and have a blood pressure below these criteria
7. History of angina that occurs with exertion or at rest or a myocardial infarction within the last 12 months
8. LDL cholesterol greater than 200 mg/dL as testosterone administration may elevate LDL cholesterol levels 9. Hematocrit greater than 51%

10. Current use of or history of recent anabolic steroid use (within 3 months) 11. Current abuse of alcohol or recreational drugs 12. Any other condition or event considered exclusionary by the PIs and covering faculty physician 13. Vulnerable populations including: individuals unable to consent on their own behalf, prisoners and pregnant women

Primary outcomes:
measure: 90 day re-hospitalization rate
timeFrame: 90 days
measure: Exercise Capacity as measured by distanced walked during 6 minute walk test at baseline study testing
timeFrame: baseline
measure: Exercise Capacity as measured by distanced walked during 6 minute walk test at 12 weeks.
timeFrame: 12 weeks
Secondary outcomes:
measure: Handgrip strength as measured by hand dyanometer at baseline study testing
timeFrame: baseline
measure: Handgrip strength as measured by hand dyanometer at 12 weeks
timeFrame: 12 weeks
measure: Difficulty breathing during the Exercise Capacity Test as measured using the Borg Dyspnea Scale (BDS) at baseline
timeFrame: baseline
measure: Difficulty breathing during the Exercise Capacity Test as measured using the Borg Dyspnea Scale (BDS) at 12 weeks
timeFrame: 12 weeks
measure: Lung function as measured by Forced Expiratory Volume (FEV1) at baseline study testing
timeFrame: baseline
measure: Lung function as measured by Forced Expiratory Volume (FEV1) at 12 weeks
timeFrame: 12 weeks
measure: Lung Function as measured by Vital Capacity (VC) at baseline
timeFrame: baseline
measure: Lung Function as measured by Vital Capacity (VC) at 12 weeks
timeFrame: 12 weeks
measure: Lung Function as measured by Forced Vital Capacity (FVC) at baseline
timeFrame: baseline
measure: Lung Function as measured by Forced Vital Capacity (FVC) at 12 weeks.
timeFrame: 12 weeks
measure: Lung Function as measured by Forced Expiratory Flow 25%-75% Forced Vital Capacity (FEF 25-75) at baseline.
timeFrame: baseline
measure: Lung Function as measured by Forced Expiratory Flow 25%-75% Forced Vital Capacity (FEF 25-75) at 12 weeks.
timeFrame: 12 weeks
measure: Lung Function as measured by Maximal Voluntary Ventilation (MVV)at baseline.
timeFrame: baseline
measure: Lung Function as measured by Maximal Voluntary Ventilation (MVV)at 12 weeks.
timeFrame: 12 weeks
measure: Fatigue as measured by Multidimensional Fatigue Symptom Inventory (MFSI) at baseline study testing.
timeFrame: baseline
measure: Fatigue as measured by Multidimensional Fatigue Symptom Inventory (MFSI) at 12 weeks
timeFrame: 12 weeks
measure: Quality of life as measured by St. George's Respiratory Questionnaire (SGRQ) at baseline.
timeFrame: baseline
measure: Quality of life as measured by St. George's Respiratory Questionnaire (SGRQ) at 12 weeks.
timeFrame: 12 weeks
measure: Quality of Life as measured by COPD Assessment Test (CAT) at baseline study testing
timeFrame: baseline
measure: Quality of Life as measured by COPD Assessment Test (CAT) at 12 weeks
timeFrame: 12 weeks
measure: Quality of life as measured by Hospital Anxiety & Depression Scale (HADS) at baseline.
timeFrame: baseline
measure: Quality of life as measured by Hospital Anxiety & Depression Scale (HADS) at 12 weeks.
timeFrame: 12 weeks
measure: Total serum testosterone at baseline
timeFrame: baseline
measure: Total serum testosterone at 12 weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Randall J Urban, MD
role: PRINCIPAL_INVESTIGATOR
References: