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

NCT ID: NCT05888597

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-24
• Study Completion Date: 2025-04-30

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).

Detailed Description

Breathelssness (Dyspnea) is a cardinal symptom in patients with chronic obstructive pulmonary disease (COPD), often triggered by daily-life physical activities. Despite optimal treatment of the underlying disease, many patients still suffer from chronic and disabling dyspnea for many years, leading to exercise intolerance, and worse morbidity and mortality. 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 COPD 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 COPD.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

Menthol

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.

Group Type: EXPERIMENTAL

L-menthol

Intervention Type: DRUG

(Sigma-Aldrich, St. Louis, US)

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

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

Interventions

L-menthol

(Sigma-Aldrich, St. Louis, US)

Intervention Type: DRUG

Placebo

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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.

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Lund University

OTHER

Sponsor Role: collaborator

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zainab Ahmadi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Region Skåne

Locations

Lund University

Lund, , Sweden

Countries

Sweden

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

Ment-COPD

Identifier Type: -

Identifier Source: org_study_id