Inhaled L-menthol for breathlessness in interstitial lung disease
Effect of L-menthol on Breathlessness and Exercise Capacity in Interstitial Lung Disease: a Randomized Crossover Trial
This trial will test whether inhaled L-menthol can reduce breathlessness and help adults with fibrosing interstitial lung disease exercise better.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Skane Academic / other |
| Locations | 2 sites (Karlskrona, Blekinge County and 1 other locations) |
| Trial ID | NCT07398287 on ClinicalTrials.gov |
What this trial studies
Adults with physician-diagnosed fibrosing ILD who can cycle and speak Swedish will receive inhaled L-menthol or a placebo and undergo exercise testing and laboratory dyspnea assessments. The study uses cardiopulmonary exercise testing (CPET) and provoked dyspnea models to measure breathlessness and exercise capacity. Investigators will compare symptom ratings, physiologic responses, and explore whether a menthol-induced cooling/olfactory sensation increases airflow-related sensory feedback. The goal is to clarify both the symptomatic effect and potential mechanisms of inhaled menthol in chronic ILD-related dyspnea.
Who should consider this trial
Good fit: Ideal participants are adults (≥18) with physician-diagnosed fibrosing ILD who are clinically stable, can cycle for exercise testing, speak Swedish, and do not require supplemental oxygen at rest or during exercise.
Not a fit: Patients with resting hypoxemia (SpO2 < 92%), current need for supplemental oxygen, recent hospitalization or clinical instability, olfactory disorders, or major cardiac/neuromuscular comorbidities are unlikely to benefit or are not eligible.
Why it matters
Potential benefit: If effective, inhaled L-menthol could offer a simple, low-cost way to relieve chronic breathlessness and improve exercise tolerance for people with ILD.
How similar studies have performed: Small pilot studies have shown promising reductions in laboratory-induced dyspnea with inhaled menthol, but larger clinical evidence is still limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The subject has given written consent to participate in the study * Physician diagnosis of fibrosing ILD according to international guidelines * age 18 years or older * able to cycle * able to understand and talk Swedish to participate in the study procedures, as judged by the Investigators. Exclusion Criteria: * Resting peripheral oxygen saturation (SpO2) \< 92% * hospitalization or clinical instability during the last four weeks * treatment with supplementary oxygen at rest or during exercise * contraindication to exercise testing in accordance with clinical practice guidelines * expected survival shorter than six months as judged by the Investigator * medical conditions including congestive heart failure, acute coronary artery disease, neuromuscular diseases, severe psychiatric illness, and olfaction disorder.
Where this trial is running
Karlskrona, Blekinge County and 1 other locations
- Blekinge Institute of Technology — Karlskrona, Blekinge County, Sweden (Recruiting)
- Lund University hospital and Region Skåne — Lund, Sweden (Recruiting)
Study contacts
- Principal investigator: Zainab Ahmadi — Region Skåne and Lund University
- Study coordinator: Zainab Ahmadi, MD, PhD
- Email: zainab.ahmadi@med.lu.se
- Phone: 046171000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.