Efficacy of L-menthol on Breathlessness in Asthma (Ment-Astma)

Region Skane

Status and phase: Not yet enrolling; Phase 2

Conditions: Asthma

Treatments: Drug: L-menthol; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07500974

Ment-Astma

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 Asthma.

Full description

Dyspnea is a cardinal symptom in patients with lung disease, 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 COPD and 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 patients with Asthma.

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 Asthma according to international guidelines
• mMRC (modified Medical Research Council) score of 1 or above
• 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