CAN BREATHE in COPD Trial

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2018-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Chronic Obstructive Pulmonary Disease (COPD) Breathlessness Exercise Intolerance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Cannabis

Intervention Type DRUG

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

Interventions

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Cannabis

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No