CAN BREATHE in COPD Trial

Sponsor

McGill University (Other)

Overall Status

Unknown status

CT.gov ID

NCT03060993

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A growing body of physiological evidence now exists to support a potential role for inhaled cannabis in the medical management of adults with chronic obstructive pulmonary disease (COPD), particularly as it may related to improving pulmonary function, alleviating the symptom of breathlessness and improving exercise endurance. The purpose of this randomized double-blind crossover trials is to evaluate the efficacy and physiological mechanism(s) of action of inhaled vaporized cannabis targeted to relief of physical activity-related breathlessness and exercise endurance in symptomatic patients with severe-to-very severe COPD.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease (COPD) Breathlessness Exercise Intolerance	Drug: Cannabis Drug: Placebo	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

16 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Effect of Inhaled Vaporized Cannabis on Pulmonary Function, Breathlessness and Exercise Tolerance in Symptomatic Patients With Advanced Chronic Obstructive Pulmonary Disease (COPD)

Anticipated Study Start Date :

Mar 1, 2017

Anticipated Primary Completion Date :

Jan 1, 2018

Anticipated Study Completion Date :

Apr 30, 2018

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Placebo 35 mg of tetrahydrocannabinol/cannabidiol (LT1.0/LT1.0 %) in vaporized form. Placebo will be vaporized using the Volcano Medic vaporizer. Total volume of vapour administered to each patient will be 5.5 L.	Drug: Placebo Patients will be administered placebo (cannabis stripped of cannabinoids) in vaporized form.
Active Comparator: Cannabis 35 mg of cannabis (tetrahydrocannabinol/cannabidiol; 18.0/LT1.0 %) in vaporized form. THC/CBD will be vaporized using the Volcano Medic vaporizer. Total volume of vapour administered to each patient will be 5.5 L.	Drug: Cannabis Patients will be administered cannabis (THC/CBD) in vaporized form.

Arm

Intervention/Treatment

Placebo Comparator: Placebo

35 mg of tetrahydrocannabinol/cannabidiol (LT1.0/LT1.0 %) in vaporized form. Placebo will be vaporized using the Volcano Medic vaporizer. Total volume of vapour administered to each patient will be 5.5 L.

Drug: Placebo

Patients will be administered placebo (cannabis stripped of cannabinoids) in vaporized form.

Active Comparator: Cannabis

35 mg of cannabis (tetrahydrocannabinol/cannabidiol; 18.0/LT1.0 %) in vaporized form. THC/CBD will be vaporized using the Volcano Medic vaporizer. Total volume of vapour administered to each patient will be 5.5 L.

Drug: Cannabis

Patients will be administered cannabis (THC/CBD) in vaporized form.

Outcome Measures

Primary Outcome Measures

Changes in intensity ratings of perceived breathlessness at isotime during cycle exercise testing. [Participants will be followed until all study visits are complete, an expected average of 4 weeks]
Patients will be required to rate the intensity of their breathlessness using Borg's modified 0-10 category ratio scale every 2-minutes during cycle exercise testing.
Changes in cycle exercise endurance time. [Participants will be followed until all study visits are complete, an expected average of 4 weeks]
Exercise endurance time will be defined as the duration of loaded pedaling during the constant-load cycle exercise testing performed at 75% of peak incremental power output.

Secondary Outcome Measures

Changes in Spirometry [Participants will be followed until all study visits are complete, an expected average of 4 weeks]
Spirometry will be performed before and 5-min after treatment administration
Changes in Impulse oscillometry [Participants will be followed until all study visits are complete, an expected average of 4 weeks]
Impulse oscillometry will be performed before and 10-min after treatment administration
Changes in Physiological responses during exercise. [Participants will be followed until all study visits are complete, an expected average of 4 weeks]
Gas exchange, cardiovascular and breathing pattern variables will be collected breath-by-breath and averaged in 30-sec epochs during incremental and constant-load cycle exercise tests.
Plasma cannabinoid levels. [Participants will be followed until all study visits are complete, an expected average of 4 weeks]
Venous blood samples for the determination of circulating levels of cannabinoids will be collected before and 2-, 30-, 75-, and 180-min after vaporization
Psychoactive effects. [Participants will be followed until all study visits are complete, an expected average of 4 weeks]
Psychoactive effects of cannabis will be evaluated during each treatment visit using 100-mm visual analogue scale (VAS). Psychoactive effects will be evaluated before and 45-min after treatment administration.
Mood effects. [Participants will be followed until all study visits are complete, an expected average of 4 weeks]
Mood effects of cannabis will be evaluated during each treatment visit using 100-mm visual analogue scale (VAS). Mood effects will be evaluated before and 45-min after treatment administration.
Cognitive effects. [Participants will be followed until all study visits are complete, an expected average of 4 weeks]
Cognitive effects will be measured during each treatment visit using the mini-mental state exam. The mini-mental state exam will be administered before and 45-min after treatment administration

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

GOLD stage III or IV COPD (i.e., post-β2-agonist FEV1 of 50% predicted or less)
Self-reported cigarette smoking history ≥10 pack yrs
Currently taking long-acting beta-2 agonists and long-acting antimuscarinic agents (LABA/LAMAs) with or without an inhaled corticosteroid
Willing to abstain from cannabis smoking for ≥15 days prior to study participation (if applicable)
Willing to abstain from non-study related cannabis smoking throughout the study period (if applicable)
No change in medication dosage or frequency of administration, with no exacerbations or hospitalizations in the preceding 4 weeks

Exclusion Criteria:

Presence of active and/or uncontrolled cardiopulmonary and/or musculoskeletal disease other than COPD that could contribute to breathlessness and exercise intolerance
Hepatic or renal impairment
Psychiatric history (other than depression and/or anxiety)
History of epilepsy or convulsions;
Lung cancer
History of sensitivity to cannabis
Use of levodopa, sildenafil and/or fentanyl
Use of ketoconazole
Use of regular high dose opioids (i.e., 30 mg of oral morphine equivalents/day)
Known or suspected history of addiction/substance abuse based on CAGE-AID and SISAP scores (*note, patients may be recruited if they have a history of smoking cannabis)
Positive urine toxicology for cannabinoids on screening
Positive pregnancy urine test
Subject cannot arrange to be accompanied home by a family member and/or friend during each treatment visit.