Randomized Crossover Trial of Inhaled L-Menthol to Reduce Breathlessness and Improve Exercise Capacity in Adults with Fibrosing Interstitial Lung Disease

What this Trial Is About

Researchers are evaluating the effect of inhaled L-menthol on breathlessness and exercise capacity in patients with interstitial lung disease ILD, a condition marked by chronic shortness of breath triggered by daily physical activities. The study aims to assess how L-menthol may relieve this symptom, building on pilot data suggesting it may reduce lab-induced breathlessness by creating a cooling sensation in the airways through olfactory stimulation. This is a Phase 2 randomized trial focused on understanding L-menthols effectiveness and mechanisms for dyspnea relief in ILD patients. Participants will receive either an L-menthol patch or a placebo patch with a strawberry scent, attached inside a facemask connected to a breathing circuit before performing submaximal cardio-pulmonary exercise tests on two separate days. The trial uses a crossover design where participants experience both treatments in a randomized order, allowing comparison of breathlessness and exercise capacity under both conditions. During the study, participants undergo detailed assessments including breathlessness intensity, unpleasantness, exercise capacity, peak dyspnea, leg fatigue, ventilatory measures, oxygen saturation, heart rate, and adverse events. These are measured during the submaximal exercise tests on days two and three, with safety monitored through follow-up for about one week. The total participation duration covers these exercise tests and safety monitoring to evaluate how inhaled L-menthol influences breathing and physical ability in ILD.

Efficacy of L-menthol on Breathlessness in Interstitial Lung Disease