Chronic obstructive pulmonary disease (COPD) Respiratory Chronic obstructive pulmonary disease, unspecified
Conditions
Interventions
Participants are randomized to either the study drug or the placebo arm for Phase I and crossed over to the other arm during Phase II. Each study phase consists of a 2-week run-in period followed by a
Sponsors
VA Loma Linda Healthcare System
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of COPD as defined by the American Thoracic Society (ATS) and European Respiratory Society (ERS) 2. Remained dyspneic despite maximal medical therapy indicated for their level of disease 3. Completed a pulmonary rehabilitation program (including reconditioning exercise, education, and support group meetings) prior to study enrollment 4. Aged over 18 years old
Exclusion criteria
Exclusion criteria: 1. Pre-enrollment urine drug screen positive for THC 2. Chronic hypercapnia (paCO2 >45 mmHg) 3. Anemic (hemoglobin <7 g/dl) 4. Pregnant 5. Known allergy to sesame seeds, sesame oil or dronabinol 6. Uncompensated acute heart failure 7. History of neuromuscular disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Sensation of dyspnea measured using the Borg dyspnea scale at rest and post exercise 2. Exercise capacity measured using shuttle walk distances before and after Phase I and II of the study 3. Sensation of dyspnea measured using PSFDQ scores before and after Phase I and II of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Fatigue measured using the Borg fatigue score at rest and post exercise 2. Respiratory symptoms and quality of life measured using SGRQ scores before and after Phase I and II 3. Quality of life measured using GDS scores before and after Phase I and II 4. The number of adverse events during the study measured using telephone follow up on a biweekly basis | — |
Countries
United States of America
Contacts
Public ContactAbdul Zaid
Outcome results
None listed