Cycled Testosterone Administration During Pulmonary Rehabilitation in Early Stage COPD

NCT ID: NCT03674320

Last Updated: 2022-02-02

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE2/PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2024-12-01

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.

Conditions

COPD

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Placebo

Placebo (saline) injections will be given via intramuscular injection at study weeks 2,3, 6, 7, 10, and 11.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo Injection (saline) will be given via intramuscular injection at study week 2, 3, 6, 7, 10 and 11.

Testosterone Enanthate

Testosterone Enanthate (100mg men, 25mg women) will be given via intramuscular injection at study weeks 2, 3, 6, 7, 10 and 11.

Group Type: ACTIVE_COMPARATOR

Testosterone Enanthate

Intervention Type: DRUG

Testosterone Enanthate (25 mg women, 100mg men) will be given via intramuscular injection at study week 2, 3, 6, 7, 10 and 11.

Interventions

Testosterone Enanthate

Testosterone Enanthate (25 mg women, 100mg men) will be given via intramuscular injection at study week 2, 3, 6, 7, 10 and 11.

Intervention Type: DRUG

Placebo

Placebo Injection (saline) will be given via intramuscular injection at study week 2, 3, 6, 7, 10 and 11.

Intervention Type: DRUG

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The University of Texas Medical Branch, Galveston

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Randall J Urban, MD

Role: PRINCIPAL_INVESTIGATOR

University of Texas

Locations

University of Texas Medical Branch

Galveston, Texas, United States

Countries

United States

Other Identifiers

18-0202

Identifier Type: -

Identifier Source: org_study_id