CAN BREATHE in COPD Trial

February 18, 2017 updated by: Dennis Jensen, Ph.D., McGill University

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Sara Abdallah, MSc.
  • Phone Number: 32465 514-934-1934

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • McConnell Centre for Innovative Medicine, Research Institute of the McGill University Health Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in intensity ratings of perceived breathlessness at isotime during cycle exercise testing.
Time Frame: 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.
Participants will be followed until all study visits are complete, an expected average of 4 weeks
Changes in cycle exercise endurance time.
Time Frame: 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.
Participants will be followed until all study visits are complete, an expected average of 4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Spirometry
Time Frame: 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
Participants will be followed until all study visits are complete, an expected average of 4 weeks
Changes in Impulse oscillometry
Time Frame: 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
Participants will be followed until all study visits are complete, an expected average of 4 weeks
Changes in Physiological responses during exercise.
Time Frame: 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.
Participants will be followed until all study visits are complete, an expected average of 4 weeks
Plasma cannabinoid levels.
Time Frame: 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
Participants will be followed until all study visits are complete, an expected average of 4 weeks
Psychoactive effects.
Time Frame: 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.
Participants will be followed until all study visits are complete, an expected average of 4 weeks
Mood effects.
Time Frame: 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.
Participants will be followed until all study visits are complete, an expected average of 4 weeks
Cognitive effects.
Time Frame: 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
Participants will be followed until all study visits are complete, an expected average of 4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
McGill University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2018

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 23, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CNBS001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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