Effect of Inhaled Fentanyl on Dyspnea and Exercise Tolerance in Chronic Obstructive Pulmonary Disease (COPD)

Inclusion Criteria:

• Post-bronchodilator forced expiratory volume in 1 sec (FEV1) 30-79% predicted, FEV1/forced vital capacity (FVC) ratio <70%;
• Clinically stable as defined by no changes in medication dosage or frequency of administration with no exacerbations or hospital admissions in the preceding 6 weeks;
• A cigarette smoking history ≥20 pack-years;
• Significant chronic activity-related dyspnea as defined by a Baseline Dyspnea Index focal score ≤ 6;
• Body mass index (BMI) between 18.5 and 30.0 kg/m2;
• Able to perform all study procedures and provide/sign informed consent.

Exclusion Criteria:

• A diffusing capacity of the lung for carbon monoxide (DLCO) <40 %predicted;
• Presence of active cardiopulmonary disease other than COPD that could contribute to dyspnea and exercise limitation;
• Clinical diagnosis of sleep disordered breathing;
• A history/clinical evidence of asthma, atopy and/or nasal polyps;
• History of allergy or adverse reaction to fentanyl;
• Presence of important contraindications to clinical exercise testing, including inability to exercise because of neuromuscular or musculoskeletal disease(s);
• Use of daytime oxygen or exercise-induced arterial oxygen desaturation to <80% on room air;
• Use of antidepressant drugs (i.e., monoamine oxidase inhibitors, serotonin reuptake inhibitors) in previous 2 weeks;
• Use of opioid or pain relieving drugs (e.g., morphine, fentanyl, oxycodone, hydromorphone, methadone, levorphanol, codeine, hydrocodone, meperidine) in previous 4 weeks.