Effect of Sublingual Fentanyl on Breathlessness in COPD

Who can take part

• 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 take part

• Concurrent use or use within 14 days of a monoamine oxidase (MAO) inhibitor
• 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%
• Scheduled major surgical procedure during the course of the study
• Self-reported history of addiction/substance abuse
• History of hypersensitivity to fentanyl or any component of the formulation
• 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)
• Dementia diagnosis or significant neurocognitive problems
• History of severe chronic kidney disease (stage 4-5)
• Malignancy, current or within the past 2 years. that the patient is not stable
• CO2 retention, defined as a resting arterial/capillary PCO2 of >50 mmHg
• Acute alcoholism
• Presence of important contraindications to cardiopulmonary exercise testing (CPET)
• Actual use of methadone
• Severe CNS depression
• Increased cerebrospinal or intracranial pressure and head injury
• Active mouth mucositis
• 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)