Efficacy of L-menthol on Breathlessness in Chronic Obstructive Pulmonary Disease

NCT05888597 | Completed Phase 2

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

Brief Summary

The purpose of this study is to assess the effect of L-menthol on breathlessness in patients with chronic obstructive pulmonary disease (COPD).

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (1)

• Breathlessness intensity

  The difference between treatment conditions in dyspnea intensity (Borg CR10 scale) at iso-time.

  Through study completion, up to 1 year

Secondary Outcomes (18)

• Dyspnea unpleasantness

  Through study completion, up to 1 year

• Total time

  Through study completion, up to 1 year

• Exercise capacity

  Through study completion, up to 1 year

• Work load

  Through study completion, up to 1 year

• Minute ventilation

  Through study completion, up to 1 year

Study Arms (2)

Menthol

EXPERIMENTAL

In the trial, 30 minutes prior to performing submaximal 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)

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
• Diagnosis of COPD confirmed by spirometry and a FEV1 \< 80% of predicted post bronchodilator at baseline
• age 18 years or older
• able to cycle
• able to understand and talk Swedish to participate in the study procedures, as judged by the Investigator.

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

• Lund University: collaborator
• Region Skane: lead

Study Sites (1)

Lund University

Lund, Sweden

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Menthol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

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, MD, PhD

  Region Skåne

  PRINCIPAL INVESTIGATOR

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), double-blinded, placebo-controlled, crossover trial (RCT) design

Study Record Dates

• First Submitted: May 2, 2023
• First Posted: June 5, 2023
• Study Start: May 24, 2023
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)