Effect of Sublingual Fentanyl on Breathlessness in COPD

• Status: Unknown status
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: McGill University
• Treatments: Citric Acid; Fentanyl; Sodium Citrate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• CO2 retention, defined as a resting arterialized capillary (earlobe) 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

• Breast-Feeding women