CAN BREATHE in COPD Trial

NCT03060993 | Unknown Phase 2 DMC FDA Drug

• 1 other identifier: CNBS001
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease (COPD); Breathlessness; Exercise Intolerance

Keywords

Cannabis; Marijuana

Outcome Measures

Primary Outcomes (2)

• Changes in intensity ratings of perceived breathlessness at isotime during cycle exercise testing.

  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.

  Participants will be followed until all study visits are complete, an expected average of 4 weeks

• Changes in cycle exercise endurance time.

  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.

  Participants will be followed until all study visits are complete, an expected average of 4 weeks

Secondary Outcomes (7)

• Changes in Spirometry

  Participants will be followed until all study visits are complete, an expected average of 4 weeks

• Changes in Impulse oscillometry

  Participants will be followed until all study visits are complete, an expected average of 4 weeks

• Changes in Physiological responses during exercise.

  Participants will be followed until all study visits are complete, an expected average of 4 weeks

• Plasma cannabinoid levels.

  Participants will be followed until all study visits are complete, an expected average of 4 weeks

• Psychoactive effects.

  Participants will be followed until all study visits are complete, an expected average of 4 weeks

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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

Cannabis

ACTIVE COMPARATOR

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

Interventions

Cannabis DRUG

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

Cannabis

Placebo DRUG

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

Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGill University: lead

Study Sites (1)

McConnell Centre for Innovative Medicine, Research Institute of the McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (1)

• Abdallah SJ, Smith BM, Ware MA, Moore M, Li PZ, Bourbeau J, Jensen D. Effect of Vaporized Cannabis on Exertional Breathlessness and Exercise Endurance in Advanced Chronic Obstructive Pulmonary Disease. A Randomized Controlled Trial. Ann Am Thorac Soc. 2018 Oct;15(10):1146-1158. doi: 10.1513/AnnalsATS.201803-198OC.

  PMID: 30049223 DERIVED

Related Links

• Clinical Exercise \& Respiratory Physiology Laboratory (CERPL) of McGill University

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Dyspnea; Marijuana Abuse

Interventions

nabiximols

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders

Study Officials

• Dennis Jensen, Ph.D.

  McGill University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Abdallah, MSc.

CONTACT

514-934-1934

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 11, 2017
• First Posted: February 23, 2017
• Study Start: March 1, 2017
• Primary Completion: January 1, 2018
• Study Completion: April 30, 2018
• Last Updated: February 23, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)