Effects of dronabinol on breathlessness and exercise capacity in chronic lung disease
| ISRCTN | ISRCTN66860544 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN66860544 |
- Submission date
- 28/12/2021
- Registration date
- 14/01/2022
- Last edited
- 19/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Plain English summary of protocol
Background and study aims
Breathlessness (dyspnea) is the most common and frequently debilitating symptom in patients with chronic obstructive pulmonary disease (COPD). The aim of this study is to determine if dronabinol improves dyspnea intensity and exercise tolerance in patients with COPD.
Who can participate?
Patients over 18 years old with COPD
What does the study involve?
Participants are randomly allocated to receive 6 weeks of oral dronabinol and 6 weeks of placebo (or vice versa) over two periods with an intervening 8- to 12-week washout period.
What are the possible benefits and risks of participating?
The results of this study will help to determine if dronabinol has a novel use in COPD patients with breathlessness. The side effects of the medication include nausea, vomiting, anxiety, confusion and sleepiness.
Where is the study run from?
VA Loma Linda Healthcare System (USA)
When is the study starting and how long is it expected to run for?
January 2011 to October 2020
Who is funding the study?
VA Loma Linda Healthcare System (USA)
Who is the main contact?
Dr Lennard Specht
Lennard.Specht@va.gov
Contact information
Public
11201 Benton St
Loma Linda
92357
United States of America
| Phone | +1 (0)909 825 7084 |
|---|---|
| docahz@gmail.com |
Principal Investigator
Medical Service
VA Loma Linda Healthcare System
11201 Benton St
Loma Linda
92357
United States of America
| Phone | +1 (0)909 825 7084 x 6098 |
|---|---|
| Lennard.Specht@va.gov |
Study information
| Study design | Prospective randomized double-blind placebo-controlled single-centre crossover study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised cross over trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet: Aimee D. Rodriguez; research coordinator at the VA Loma Linda Healthcare System; Aimee.Rodriguez@va.gov |
| Scientific title | Effects of dronabinol on dyspnea and quality of life in patients with chronic obstructive pulmonary disease: a randomized cross-over trial |
| Study objectives | To determine if dronabinol improves dyspnea intensity and thereby exercise tolerance in chronic obstructive pulmonary disease (COPD). |
| Ethics approval(s) | Approved 14/12/2011, Institutional review board, VA Loma Linda Healthcare System (11201 Benton St, Loma Linda, CA 92357, USA; +1 (0)9 825 7084, ext. 2264; Sunbeam.Obomsawin@va.gov), ref: 00929, Prom# U28 |
| Health condition(s) or problem(s) studied | Chronic obstructive pulmonary disease (COPD) |
| Intervention | 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 4-week treatment period. Depending on the arm of the study they are in, subjects start on either placebo or dronabinol 5 mg capsules orally. During the run-in period, the number of capsules of the study drug is gradually increased from one per day up to four per day. In case of adverse effects such as lightheadedness, subjects are asked to decrease the number of capsules per day to the last tolerated level. On completion of the first phase, each patient undergoes an 8- to 12-week washout. This is followed by crossover to a similarly structured Phase II. Run-in period I (2 weeks) Day 0: fill out questionnaire packet and answer adverse drug reaction Screen and perform Incremental Shuttle Walk Test (ISWT) - start dronabinol 5 mg by mouth or placebo daily x 3 days. Day 3: answer adverse drug reaction screen - if no adverse effects are reported, increase the dose to 5 mg by mouth twice a day Day 6: answer adverse drug reaction screen - if no adverse effects are reported, increase the dose to 5 mg by mouth three times a day Day 9: answer adverse drug reaction screen - if no adverse effects are reported, increase the dose to 5 mg by mouth four times a day Day 12: answer adverse drug reaction screen - if no adverse effects are reported, continue 20 mg daily in divided doses **Note: Sham titration conducted of the placebo arm following the exact same schedule as laid out above Treatment period I (4 weeks) 1. Group A receives doses of oral dronabinol (Δ9-THC) 2. Group B receives a placebo that is identical in appearance Followed by a wash-out period (8-12 weeks) The groups will then be crossed over so that during Phase II, group A will receive a placebo and group B will receive dronabinol. Phase II Run-in II and treatment period II will be conducted with an identical protocol to run-in I and treatment period I, respectively. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Dronabinol |
| Primary outcome measure | 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 outcome measures | 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 |
| Overall study start date | 06/01/2011 |
| Completion date | 03/10/2020 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 50 |
| Total final enrolment | 24 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 29/07/2013 |
| Date of final enrolment | 22/10/2019 |
Locations
Countries of recruitment
- United States of America
Study participating centre
Loma Linda
92357
United States of America
Sponsor information
Hospital/treatment centre
11201 Benton St
Loma Linda
CA 92357
United States of America
| Phone | +1 (0)909 796 4508 |
|---|---|
| sunbeam.obomsawin@va.gov | |
| Website | http://www.lomalinda.va.gov/ |
"ROR" |
https://ror.org/03z6z3n38 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/01/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Published as a supplement to the results publication |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal. The study protocol is available on request. The statistical analysis plan is within the manuscript and supplemental material is available on request. |
| IPD sharing plan | The datasets generated and/or analysed during the current study will be published as a supplement to the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | 05/04/2019 | 19/10/2022 | No | No |
Additional files
Editorial Notes
19/10/2022: Protocol uploaded (not peer reviewed).
12/01/2022: Trial's existence confirmed by the institutional review board, VA Loma Linda Healthcare System.
