NAL ER for Idiopathic Pulmonary Fibrosis

This trial investigates a new treatment called NAL ER, an extended-release medication, for individuals with idiopathic pulmonary fibrosis (IPF), a lung disease that makes breathing difficult. The trial aims to determine the safety of NAL ER and its effects on breathing in people with IPF. Participants will initially take a placebo, a pill with no active medicine, and then try different doses of NAL ER. This trial may suit those diagnosed with IPF who do not require overnight oxygen therapy and have not experienced a recent flare-up. As a Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this new treatment.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Previous studies have used NAL ER to treat cough in people with idiopathic pulmonary fibrosis (IPF). While the treatment reduced cough, some side effects occurred, including nausea, tiredness, constipation, and dizziness. About 23.6% of participants discontinued the drug due to these issues. This trial is in an early stage, focusing on safety and tolerability. So far, evidence suggests that although NAL ER can cause some discomfort, it is being carefully tested to ensure safety for further use.¹²³⁴⁵

Unlike the standard treatments for idiopathic pulmonary fibrosis, which often focus on slowing disease progression, NAL ER offers a new approach by potentially accelerating symptom relief. Researchers are excited about NAL ER because it involves a novel dosing regimen where participants start with a placebo for two days before escalating doses of NAL ER. This method may aid in better management of the condition with possibly faster results. The twice-daily tablet form could also improve patient compliance compared to more complex treatment schedules.

Research has shown that NAL ER, the treatment under study in this trial, may help reduce daytime coughing in people with idiopathic pulmonary fibrosis (IPF). In one study, 42% of patients taking NAL ER experienced a 75% reduction in cough frequency, while no one in the placebo group showed this improvement. Another study found that NAL ER quickly and significantly reduced coughing by 75.1%. Overall, patients using NAL ER have reported less daytime coughing, suggesting it could help manage IPF symptoms. Although these results are promising, further research is needed to fully understand its effects.²³⁵⁶⁷