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Recruiting Phase 2 NCT07398287

Efficacy of L-menthol on Breathlessness in Interstitial Lung Disease

Phase 2 – studying effectiveness and dosage
Conditions: Interstitial Lung Disease (ILD)

Sponsor: Region Skane

trial.available_in: БГ
Overview
The purpose of this study is to assess the effect of L-menthol on breathlessness and exercise capacity in patients with Interstitial lung disease (ILD).
Description
Dyspnea is a cardinal symptom in patients with interstitial lung disease (ILD), often triggered by daily-life physical activities. To date, an effective pharmacologic treatment to relieve chronic dyspnea is lacking. Recent pilot data support that inhaled L-menthol can markedly decrease laboratory-induced dyspnea in ILD patients, likely through increased afferent feedback of airflow in the airways by inducing a cooling sensation through olfactory stimulation. The aim of this study is therefore to assess the effectiveness and mechanisms of inhaled menthol for relief of chronic dyspnea in patients with ILD.
Who can participate
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.
Interventions
L-menthol
DRUG
Placebo
OTHER
Locations 2
Sweden (2)
Blekinge Institute of Technology
Karlskrona , Blekinge County
Lund University hospital and Region Skåne
Lund
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
13.04.2026
Completion date
01.05.2027
Registry ID
NCT07398287
Source
clinicaltrials.gov
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