Effect of Sublingual Fentanyl on Breathlessness in COPD

NCT04004117 | Terminated Phase 2 DMC

• 1 other identifier: RIMUHCCOPDJB
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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 severe COPD patients experiencing persistent breathlessness despite optimal management.

Conditions

Copd

Outcome Measures

Primary Outcomes (2)

• Breathlessness

  Post-dose difference in exertional breathlessness at isotime (isotime definition : highest equivalent 2 min interval of exercise completed by a given participant).

  Up to 10 days after visit 1

• Exercise capacity

  Post-dose difference in exercise endurance time (EET)

  Up to 10 days after visit 1

Secondary Outcomes (6)

• Number and description of adverse effects

  Up to 48 hours after treatment administration

• Locus of Symptoms

  Up to 10 days after visit 1

• Qualitative descriptors of breathlessness at end exercise

  Up to 10 days after visit 1

• Change in multidimensional evaluation of dyspnea

  Up to 10 days after visit 1

• Participant blinded preference

  Up to 10 days after visit 1

Study Arms (2)

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).

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.

Drug: Fentanyl citrate solution sublingual; Drug: Placebo oral liquid

Interventions

Fentanyl citrate solution sublingual DRUG

Solution of fentanyl citrate (DIN : 02384124 / 02240434 / 02385406) will be administered sublingually by syringe. The dose is 12,5 mcg.

Fentanyl s/l; Placebo

Placebo oral liquid DRUG

Placebo will consist in simple syrup (simple syrup B.P. - NPN: 00050121) administered sublingually with syringe.

Fentanyl s/l; Placebo

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Canadian Institutes of Health Research (CIHR): collaborator
• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Royal University Hospital, Saskatoon: collaborator

Study Sites (1)

Royal University Hospital

Saskatoon, Saskatchewan, S7N0W8, Canada

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jean Bourbeau, MD

  Reseach Institute MUHC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All research staff, treating clinicians, analysts and patients will remain blinded to the treatment allocation. Unbinding will only occur in emergency situations following consultation with the principal investigator and at the conclusion of collecting the last data point for the last participant in the entire study.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Multicentered randomized clinical trial, triple-blinded, cross-over design, comparing fentanyl sublingual at a dose 12,5 mcg to placebo.

Study Record Dates

• First Submitted: May 27, 2019
• First Posted: July 1, 2019
• Study Start: July 1, 2019
• Primary Completion: December 31, 2019
• Study Completion: February 4, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)