Efficacy of L-menthol on Breathlessness in Interstitial Lung Disease (Ment-ILD)

Region Skane

Status and phase: Not yet enrolling; Phase 2

Conditions: Interstitial Lung Disease (ILD)

Treatments: Other: Placebo; Drug: L-menthol

Study type: Interventional

Funder types: Other

Identifiers

NCT07398287

Ment-ILD

Details and patient eligibility

About

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).

Full 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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

L-Menthol

Experimental group

Description:

In the trial, prior to performing submaximal cardio-pulmonary exercise testing (CPET), participants will be administered, L-menthol patch which will be attached to the inside of a facemask that is connected to the breathing circuit.

Treatment:

Drug: L-menthol

Placebo

Placebo Comparator group

Description:

For placebo, the patch will contain a similarly patch with strawberry scent.

Treatment:

Other: Placebo