Fentanyl Citrate in PF

Fentanyl is a narcotic analgesic that is used for the treatment of sudden episodes of pain in cancer patients who already take other pain medications. It works by changing the way the brain and nervous system respond to pain. A clinical trial is recruiting patients with idiopathic pulmonary fibrosis (IPF) to evaluate the effects of inhaled fentanyl citrate.

Fentanyl should not be used more than four times a day. A doctor will probably start the patient on a low dose and increase it gradually until a dose relieves the breakthrough pain. Fentanyl may be habit-forming, so its dose should not be exceeded. It also may cause withdrawal symptoms if suddenly stopped.

Some of the most common fentanyl side effects include drowsiness; stomach pain; gas; heartburn; weight loss; difficulty urinating; changes in vision; anxiety; depression; unusual dreams; sleeping disorders; dry mouth; reddening of the face, neck or upper chest; uncontrollable shaking of a part of the body; back and chest pain; and swelling of the hands, arms, feet, ankles or lower legs.

Fentanyl research in PF

People with idiopathic pulmonary fibrosis (IPF) experience breathing discomfort that is difficult to handle therapeutically. There are different possible interventions, such as pulmonary rehabilitation, self-management, oxygen therapy and opiate analgesics, although each person may respond differently to each of the treatments. Opiate analgesics can improve breathing difficulties by reducing central respiratory neural drive.

A Phase 3 study is currently recruiting participants (NCT03018756) to evaluate the effects of inhaled fentanyl citrate in people with mild-to-moderate IPF and difficulty breathing (dyspnea).

The study’s primary objectives are breathing discomfort during 10 minutes on a treadmill. Secondary objectives will be the measure of a diaphragm electromyography during the treadmill exercise. A diaphragm electromyography can provide electrical assessment of diaphragm function for respiratory assessment. Others are the ventilation, breathing frequency, tidal volume and inspiratory capacity during treadmill exercise.

This study expects to enroll 20 participants age 40 and older and is estimated to be completed in December 2017.

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