Efficacy of L-menthol on Breathlessness in Interstitial Lung Disease

NCT07398287 | Recruiting Phase 2

• 1 other identifier: Ment-ILD
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief Summary

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).

Conditions

Interstitial Lung Disease (ILD)

Keywords

interstitial lung disease; breathlessness; dyspnea; CPET; exercise

Outcome Measures

Primary Outcomes (1)

• Breathlessness intensity

  The difference between treatment conditions in dyspnea intensity at iso-time. The Borg's modified 0-10 category ratio scale (Borg CR10) will be used, where 0 represents no perceived breathlessness at all, and 10 represents maximum breathlessness intensity ever experienced.

  During submaximal test, at isotime during day 2 and day 3.

Secondary Outcomes (15)

• Dyspnea unpleasantness

  During submaximal test, at iso-time during day 2 and day 3.

• Total time

  At the end of submaximal test during day 2 and day 3.

• Exercise capacity

  Submaximal test during day 2 and day 3.

• Peak dyspnea intensity

  During submaximal test, at peak during day 2 and day 3.

• Leg fatigue

  During submaximal test at day 2 and day 3.

Study Arms (2)

L-Menthol

EXPERIMENTAL

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.

Drug: L-menthol

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

L-menthol DRUG

(Sigma-Aldrich, St. Louis, US)

L-Menthol

Placebo OTHER

Strawberry scent (Sigma-Aldrich, St. Louis, US)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Blekingesjukhuset, Karlskrona: collaborator
• Region Skane: lead
• Blekinge Institute of Technology: collaborator
• Lund University: collaborator

Study Sites (2)

Blekinge Institute of Technology

Karlskrona, Blekinge County, Sweden

RECRUITING

Lund University hospital and Region Skåne

Lund, Sweden

RECRUITING

MeSH Terms

Conditions

Lung Diseases, Interstitial; Dyspnea; Motor Activity

Interventions

Menthol

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Monoterpenes; Terpenes; Lipids

Study Officials

• Zainab Ahmadi

  Region Skåne and Lund University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zainab Ahmadi, MD, PhD

CONTACT

046171000; zainab.ahmadi@med.lu.se

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multi-center, randomized (ratio 1:1), placebo-controlled, crossover trial (RCT) design

Study Record Dates

• First Submitted: January 13, 2026
• First Posted: February 9, 2026
• Study Start: April 13, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

SE (2)