Efficacy of L-menthol on Breathlessness in Chronic Obstructive Pulmonary Disease (Ment-COPD)

Region Skane

Status and phase: Completed; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Other: Placebo; Drug: L-menthol

Study type: Interventional

Funder types: Other

Identifiers

NCT05888597

Ment-COPD

Details and patient eligibility

About

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

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

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

Menthol

Experimental group

Description:

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.

Treatment:

Drug: L-menthol

Placebo

Placebo Comparator group

Description:

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

Treatment:

Other: Placebo