CopdPhase 2/3NCT04004117
Effect of Sublingual Fentanyl on Breathlessness in COPD
A Phase 2/3 study testing Fentanyl citrate solution sublingual in people with Copd, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial summary
There is actually no physiologic or clinical data in the literature to clearly define the potential benefits and side effects of sublingual fentanyl in patients with COPD. Therefore, the purpose of this study is to test the hypothesis that sublingual fentanyl will improve exercise capacity and dyspnea control in… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Copd
- What is being tested?
- Fentanyl citrate solution sublingual
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2019to 4 Feb 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female aged ≥ 40 years
- Cigarette smoking history ≥10 pack years
- Clinical diagnosis of severe to very severe COPD, i.e. post-β2-agonist FEV1 <50% and FEV1/FVC <0.70
- Chronic activity-related dyspnea, define as any one or combination of a modified MRC of 3-4 or a BDI focal score ≤ 8
- Uncontrolled daily activity-related dyspnea despite optimal medical treatment, including oral morphine treatment at a dose of a least 4 mg per day
- No change in medication dosage or frequency of administration in the previous 2 weeks
- No exacerbations or hospitalizations in the preceding 4 weeks
Who cannot join
- CO2 retention, defined as a resting arterial/capillary PCO2 of >50 mmHg
- Self-reported history of addiction/substance abuse
- Acute alcoholism
- Presence of important contraindications to cardiopulmonary exercise testing (CPET)
- History of hypersensitivity to fentanyl or any component of the formulation
- Actual use of methadone
Show all 20Show fewer
- Concurrent use or use within 14 days of a monoamine oxidase (MAO) inhibitor
- Severe CNS depression
- Convulsive disorders
- Known or suspected mechanical GI obstruction (e.g., bowel obstruction or strictures) or any diseases/conditions that affect bowel transit (e.g., ileus of any type)
- Increased cerebrospinal or intracranial pressure and head injury
- Active mouth mucositis
- Dementia diagnosis or significant neurocognitive problems
- History of severe chronic kidney disease (stage 4-5)
- Women of child bearing potential (defined as not having gone at least 12 months without a menstrual period) will be required to take a routine (urine) pregnancy test to rule out the possibility of pregnancy
- Breast-Feeding women
- Acute or unstable, clinically significant abnormal findings in physical exam, vital signs or ECG (as per Investigators opinion)
- Patients receiving long-term treatment with Oxygen >4.0 liters/minute (L/min). They must be ambulatory and be able to attend clinic visits. While breathing supplemental oxygen, they must demonstrate an oxyhemoglobin saturation ≥ 89%.
- Malignancy, current or within the past 2 years. that the patient is not stable
- Scheduled major surgical procedure during the course of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Sublingual Fentanyl on Breathlessness in COPD : A Randomized Cross-over Trial
There is actually no physiologic or clinical data in the literature to clearly define the potential benefits and side effects of sublingual fentanyl in patients with COPD. Therefore, the purpose of this study is to test the hypothesis that sublingual fentanyl will improve exercise capacity and dyspnea control in severe COPD patients experiencing persistent breathlessness despite optimal management.
Read the detailed description
The purpose of this study is to test the hypothesis that sublingual fentanyl will improve exercise capacity and dyspnea control in severe COPD patients experiencing persistent breathlessness despite optimal management.
To demonstrate the effectiveness of sublingual fentanyl, the investigators suggest a dose of 12,5 mcg. The investigators base this decision on several considerations :
- Local practice and experience : the safety of a dose of 12,5 mcg of sublingual fentanyl has been show in the investigators local experience (see section 1.3 Clinical experience with fentanyl).
- Although there is not enough information to determine the exact equivalence between sublingual fentanyl and oral morphine, the conversion between intravenous fentanyl and oral morphine can be done. Based on the monograph of fentanyl citrate, 10 mcg of intravenous fentanyl citrate are equivalent to 10 mg of intravenous morphine, which are equivalent to 20 to 30 mg of oral morphine. Subsequently, 12,5 mcg of sublingual fentanyl may be equivalent to a oral morphine dose between 2,5 and 3,75 milligrams. This represent a smaller dose than the dose of 0,1 mg/kg oral morphine that was demonstrated to be safe in a recent study done by a group at McGill in a severe COPD population (Abdallah et al. Eur Respir J 2017; 50: 1701235).
- The study will only include patients who are already on morphine, because they represent the target population and have less risk of adverse events than an opioid-naive population.
- To ensure safety, participants will be actively monitored during the study. A doctor will be present at administration of the drug and the antidote, naloxone, will be readily available if needed. Participants will be monitored on-site for 30 minutes after completion of CPET and discharge only if no evidence of side effects. Participants will be informed to not drive for 24 hours following each period of treatment. A phone call follow-up will be done 24-48 hours after treatment visits.
General Objective:
The general objective is to demonstrate the role of sublingual fentanyl liquid to improve exertional shortness of breath in patients with severe to very severe COPD.
Primary Objective :
The primary objective is to evaluate in severe/very-severe COPD the effect of 12,5 mcg fentanyl sublingual liquid as compared with placebo, on i) post-dose difference in exertional breathlessness at isotime (Isotime definition : highest equivalent 2 min interval of exercise completed by a given participant) ii) Post-dose difference in exercise endurance time (EET)
The study is a multicentred randomized clinical trial, triple-blinded, cross-over design, comparing fentanyl sublingual at a dose 12,5 mcg to placebo in severe/very-severe COPD already taking low dose of morphine because of refractory dyspnea.
To detect a minimally clinically important (MCID) difference of 1 Borg unit (40) at iso-time between treatments, we assume an α of 0.05 and a within-subject standard deviation of 1 Borg unit: a total of 20 patients will provide >80% power; assuming an attrition rate of 20%, a total of 24 patients will be recruited for this study.
All data will be de-nominalized in order to respect privacy. Data will be collected in an anonymous data sheet, protected by a password. Only investigators and statistician will have access to this data sheet.
The principal analysis of the relative change in dyspnea intensity at iso-time (primary end-point) after treatment with morphine sulfate vs. placebo will be conducted using an unadjusted paired t-test. Secondary analyses to assess treatment responses on secondary end-points (e.g. arterialized capillary PCO2, EET, dyspnea unpleasantness, ventilation, breathing pattern, operating lung volumes, etc.) will be done using paired t-tests adjusted (Bonferroni) for multiple comparisons. Pearson correlations will be used to establish associations between intra-subject post-dose differences in iso-time dyspnea intensity ratings and relevant independent variables (e.g. arterialized capillary PCO2, ventilation, breathing pattern, MDP results, etc.) and various baseline patient characteristics (possible covariates). Stepwise multiple regression analysis will then be carried out with significant independent variables and relevant covariates.
- Conditions
- Copd
- Being tested
- Fentanyl citrate solution sublingual, Placebo oral liquid
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fentanyl citrate solution sublingualDrug
Solution of fentanyl citrate (DIN : 02384124 / 02240434 / 02385406) will be administered sublingually by syringe. The dose is 12,5 mcg.
Placebo oral liquidDrug
Placebo will consist in simple syrup (simple syrup B.P. - NPN: 00050121) administered sublingually with syringe.
| Study group | Role | What they receive |
|---|---|---|
| Fentanyl s/l | Experimental | Sublingual fentanyl will consist in liquid fentanyl at a concentration of 25 mcg/mL, with preparation by the pharmacist of pre-dosed syringes of 12,5 mcg (0,5 mL). Receives: Drug: Fentanyl citrate solution sublingual; Drug: Placebo oral liquid |
| Placebo | Placebo comparator | Placebo will consist in simple syrup (simple syrup B.P. - NPN: 00050121) administered sublingually with syringe. Receives: Drug: Fentanyl citrate solution sublingual; Drug: Placebo oral liquid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Breathlessness
Post-dose difference in exertional breathlessness at isotime (isotime definition : highest equivalent 2 min interval of exercise completed by a given participant).
Measured: Up to 10 days after visit 1
Exercise capacity
Post-dose difference in exercise endurance time (EET)
Measured: Up to 10 days after visit 1
Secondary outcomes (6)
Number and description of adverse effects
Number and description of adverse effects
Measured: Up to 48 hours after treatment administration
Locus of Symptoms
Percentage contribution of breathlessness and leg discomfort to exercise cessation
Measured: Up to 10 days after visit 1
Qualitative descriptors of breathlessness at end exercise
Description by patients of the characteristics of breathlessness at the end of exercise
Measured: Up to 10 days after visit 1
Change in multidimensional evaluation of dyspnea
Evaluation of the multidimensional components of dyspnea following each intervention and using the Multidimensional Dyspnea Profile (MDP) questionnaire. The questionnaire contains a total of 11 questions to characterize dyspnea. Each questions is a symptom or a sensation that need to be rated on scale from 0 to 10 depending on the intensity of the symptom/sensation, with 0 representing the absence of symptom and 10 representing the higher perception of symptom. There is no combination to form a total score.
Measured: Up to 10 days after visit 1
Participant blinded preference
At the last visit, the investigators will ask to patients which intervention they preferred regarding relief of breathlessness and comfort during exercise
Measured: Up to 10 days after visit 1
Difference in the locus of symptoms limiting exercise during a cardio-pulmonary exercise test response when comparing responders to non-responders.
Responders will be define as participant with ≥ 1-point improvement in Borg dyspnea. The locus of symptom is the symptom that limit the exercise test (breathlessness, leg fatigue or both).
Measured: Up to 10 days after visit 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start1 Jul 2019
- Primary completion31 Dec 2019
- Study completion4 Feb 2026
Why it stopped: Clinical trial discontinued for reason pertaining to lack of efficacy.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CopdStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Multicentered randomized clinical trial, triple-blinded, cross-over design, comparing fentanyl sublingual at a dose 12,5 mcg to placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Royal University Hospital, Saskatoon
- Responsible party
- Principal investigator, Jean Bourbeau, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Jean Bourbeau, MD, Principal investigator, Reseach Institute MUHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04004117
- Sponsor's protocol ID
- RIMUHCCOPDJB
- Status last verified
- Feb 2026
- First submitted
- 27 May 2019
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to have the data share by other researcher. All data will be denominalized in order to respect privacy. Data will be collected in an anonymous data sheet, protected by a password. Only investigators and statistician will have access to this data sheet.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Sublingual Fentanyl on Breathlessness in COPD : A Randomized Cross-over Trial
- ClinicalTrials.gov ID
- NCT04004117
- Acronym / sponsor ID
- RIMUHCCOPDJB
- Conditions
- Copd
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Clinical trial discontinued for reason pertaining to lack of efficacy.
- Enrolment
- 40 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Royal University Hospital, Saskatoon
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 4 Feb 2026 (actual)
- First posted
- 1 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
There is actually no physiologic or clinical data in the literature to clearly define the potential benefits and side effects of sublingual fentanyl in patients with COPD. Therefore, the purpose of this study is to test the hypothesis that sublingual fentanyl will improve exercise capacity and dyspnea control in severe COPD patients experiencing persistent breathlessness despite optimal management.
Detailed description
The purpose of this study is to test the hypothesis that sublingual fentanyl will improve exercise capacity and dyspnea control in severe COPD patients experiencing persistent breathlessness despite optimal management.
To demonstrate the effectiveness of sublingual fentanyl, the investigators suggest a dose of 12,5 mcg. The investigators base this decision on several considerations :
- Local practice and experience : the safety of a dose of 12,5 mcg of sublingual fentanyl has been show in the investigators local experience (see section 1.3 Clinical experience with fentanyl).
- Although there is not enough information to determine the exact equivalence between sublingual fentanyl and oral morphine, the conversion between intravenous fentanyl and oral morphine can be done. Based on the monograph of fentanyl citrate, 10 mcg of intravenous fentanyl citrate are equivalent to 10 mg of intravenous morphine, which are equivalent to 20 to 30 mg of oral morphine. Subsequently, 12,5 mcg of sublingual fentanyl may be equivalent to a oral morphine dose between 2,5 and 3,75 milligrams. This represent a smaller dose than the dose of 0,1 mg/kg oral morphine that was demonstrated to be safe in a recent study done by a group at McGill in a severe COPD population (Abdallah et al. Eur Respir J 2017; 50: 1701235).
- The study will only include patients who are already on morphine, because they represent the target population and have less risk of adverse events than an opioid-naive population.
- To ensure safety, participants will be actively monitored during the study. A doctor will be present at administration of the drug and the antidote, naloxone, will be readily available if needed. Participants will be monitored on-site for 30 minutes after completion of CPET and discharge only if no evidence of side effects. Participants will be informed to not drive for 24 hours following each period of treatment. A phone call follow-up will be done 24-48 hours after treatment visits.
General Objective:
The general objective is to demonstrate the role of sublingual fentanyl liquid to improve exertional shortness of breath in patients with severe to very severe COPD.
Primary Objective :
The primary objective is to evaluate in severe/very-severe COPD the effect of 12,5 mcg fentanyl sublingual liquid as compared with placebo, on i) post-dose difference in exertional breathlessness at isotime (Isotime definition : highest equivalent 2 min interval of exercise completed by a given participant) ii) Post-dose difference in exercise endurance time (EET)
The study is a multicentred randomized clinical trial, triple-blinded, cross-over design, comparing fentanyl sublingual at a dose 12,5 mcg to placebo in severe/very-severe COPD already taking low dose of morphine because of refractory dyspnea.
To detect a minimally clinically important (MCID) difference of 1 Borg unit (40) at iso-time between treatments, we assume an α of 0.05 and a within-subject standard deviation of 1 Borg unit: a total of 20 patients will provide >80% power; assuming an attrition rate of 20%, a total of 24 patients will be recruited for this study.
All data will be de-nominalized in order to respect privacy. Data will be collected in an anonymous data sheet, protected by a password. Only investigators and statistician will have access to this data sheet.
The principal analysis of the relative change in dyspnea intensity at iso-time (primary end-point) after treatment with morphine sulfate vs. placebo will be conducted using an unadjusted paired t-test. Secondary analyses to assess treatment responses on secondary end-points (e.g. arterialized capillary PCO2, EET, dyspnea unpleasantness, ventilation, breathing pattern, operating lung volumes, etc.) will be done using paired t-tests adjusted (Bonferroni) for multiple comparisons. Pearson correlations will be used to establish associations between intra-subject post-dose differences in iso-time dyspnea intensity ratings and relevant independent variables (e.g. arterialized capillary PCO2, ventilation, breathing pattern, MDP results, etc.) and various baseline patient characteristics (possible covariates). Stepwise multiple regression analysis will then be carried out with significant independent variables and relevant covariates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Multicentered randomized clinical trial, triple-blinded, cross-over design, comparing fentanyl sublingual at a dose 12,5 mcg to placebo.
| Arm | Type | Receives |
|---|---|---|
| Fentanyl s/l | Experimental | Drug: Fentanyl citrate solution sublingual, Drug: Placebo oral liquidSublingual fentanyl will consist in liquid fentanyl at a concentration of 25 mcg/mL, with preparation by the pharmacist of pre-dosed syringes of 12,5 mcg (0,5 mL). |
| Placebo | Placebo comparator | Drug: Fentanyl citrate solution sublingual, Drug: Placebo oral liquidPlacebo will consist in simple syrup (simple syrup B.P. - NPN: 00050121) administered sublingually with syringe. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female aged ≥ 40 years
- Cigarette smoking history ≥10 pack years
- Clinical diagnosis of severe to very severe COPD, i.e. post-β2-agonist FEV1 <50% and FEV1/FVC <0.70
- Chronic activity-related dyspnea, define as any one or combination of a modified MRC of 3-4 or a BDI focal score ≤ 8
- Uncontrolled daily activity-related dyspnea despite optimal medical treatment, including oral morphine treatment at a dose of a least 4 mg per day
Key exclusion criteria (20 listed)
- CO2 retention, defined as a resting arterial/capillary PCO2 of >50 mmHg
- Self-reported history of addiction/substance abuse
- Acute alcoholism
- Presence of important contraindications to cardiopulmonary exercise testing (CPET)
- History of hypersensitivity to fentanyl or any component of the formulation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fentanyl citrate solution sublingualSolution of fentanyl citrate (DIN : 02384124 / 02240434 / 02385406) will be administered sublingually by syringe. The dose is 12,5 mcg. | Drug | Fentanyl s/l, Placebo |
| Placebo oral liquidPlacebo will consist in simple syrup (simple syrup B.P. - NPN: 00050121) administered sublingually with syringe. | Drug | Fentanyl s/l, Placebo |
Primary outcome
Breathlessness
Time frame: Up to 10 days after visit 1
Post-dose difference in exertional breathlessness at isotime (isotime definition : highest equivalent 2 min interval of exercise completed by a given participant).
Exercise capacity
Time frame: Up to 10 days after visit 1
Post-dose difference in exercise endurance time (EET)
6 secondary outcomes
Number and description of adverse effects
Time frame: Up to 48 hours after treatment administration
Locus of Symptoms
Time frame: Up to 10 days after visit 1
Qualitative descriptors of breathlessness at end exercise
Time frame: Up to 10 days after visit 1
Change in multidimensional evaluation of dyspnea
Time frame: Up to 10 days after visit 1
Participant blinded preference
Time frame: Up to 10 days after visit 1
Difference in the locus of symptoms limiting exercise during a cardio-pulmonary exercise test response when comparing responders to non-responders.
Time frame: Up to 10 days after visit 1
Results and safety
The study was stopped early (reason given: Clinical trial discontinued for reason pertaining to lack of efficacy.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No. No plan to have the data share by other researcher. All data will be denominalized in order to respect privacy. Data will be collected in an anonymous data sheet, protected by a password. Only investigators and statistician will have access to this data sheet.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Bourbeau, MD principal investigator
Reseach Institute MUHC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Fentanyl citrate solution sublingual in people with Copd, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Clinical trial discontinued for reason pertaining to lack of efficacy.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breathlessness (time frame: Up to 10 days after visit 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2026.