Effect of Sublingual Fentanyl on Breathlessness in COPD

Participation Requirements

• Sex:

  ALL

• Eligible Ages:

  40 and up

Participation 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 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
* 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