Cycled Testosterone Administration During Pulmonary Rehabilitation in Early Stage COPD

NCT03674320 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: 18-0202
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD

Outcome Measures

Primary Outcomes (3)

• 90 day re-hospitalization rate

  Re-hospitalization rates will be collected from the electronic medical record and/or subject interviews.

  90 days

• Exercise Capacity as measured by distanced walked during 6 minute walk test at baseline study testing

  Exercise capacity will be measured by distance walked in 6 minutes on a predefined course. Subjects will be asked to walk at 100% effort (as quickly as they can safely walk without running) for 6 minutes. Distance traveled for the 6 minutes will be recorded. The walking test will be completed at baseline. Data will be reported as meters (m) walked in 6 minutes.

  baseline

• Exercise Capacity as measured by distanced walked during 6 minute walk test at 12 weeks.

  Exercise capacity will be measured by distance walked in 6 minutes on a predefined course. Subjects will be asked to walk at 100% effort (as quickly as they can safely walk without running) for 6 minutes. Distance traveled for the 6 minutes will be recorded. The walking test will be completed at baseline. Data will be reported as meters (m) walked in 6 minutes.

  12 weeks

Secondary Outcomes (24)

• Handgrip strength as measured by hand dyanometer at baseline study testing

  baseline

• Handgrip strength as measured by hand dyanometer at 12 weeks

  12 weeks

• Difficulty breathing during the Exercise Capacity Test as measured using the Borg Dyspnea Scale (BDS) at baseline

  baseline

• Difficulty breathing during the Exercise Capacity Test as measured using the Borg Dyspnea Scale (BDS) at 12 weeks

  12 weeks

• Lung function as measured by Forced Expiratory Volume (FEV1) at baseline study testing

  baseline

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Testosterone Enanthate

ACTIVE COMPARATOR

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

Drug: Testosterone Enanthate

Interventions

Testosterone Enanthate DRUG

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

Testosterone Enanthate

Placebo DRUG

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

Placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Late stage COPD, GOLD Stage 3-4 (FEV1 \> 60% predicted)
• Inability to perform 6-minute walking test or other physical therapy activities
• Inability/unwillingness to follow the pulmonary rehabilitation program
• Already more than 2 weeks into the pulmonary rehabilitation program at time of consenting
• Uncontrolled endocrine or metabolic disease (e.g. liver disease, renal disease, diabetes)
• 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
• History of angina that occurs with exertion or at rest or a myocardial infarction within the last 12 months
• LDL cholesterol greater than 200 mg/dL as testosterone administration may elevate LDL cholesterol levels 9. Hematocrit greater than 51%

Sponsors & Collaborators

• The University of Texas Medical Branch, Galveston: lead

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

testosterone enanthate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Randall J Urban, MD

  University of Texas

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 17, 2018
• Study Start: December 1, 2021
• Primary Completion: August 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 2, 2022

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)