Efficacy of L-menthol on Breathlessness in Asthma

Phase 2Not Yet RecruitingNCT07500974

Region Skane20 enrolled

Overview

The purpose of this study is to assess the effect of L-menthol on breathlessness and exercise capacity in patients with Asthma.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Asthma

Interventions

L-mentholDRUG

(Sigma-Aldrich, St. Louis, US)

PlaceboOTHER

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (2)

Blekinge Institute of Technology

Karlskrona, Blekinge County, Sweden

Lund University hospital and Region Skåne

Lund, Sweden

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Dyspnea unpleasantness

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

Time frame: During submaximal test, at iso-time during day 2 and day 3

Total time

Time to the limit of tolerance (s) (tLIM)

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

Exercise capacity

V'O2 (aerobic exercise capacity, absolute and in %pred)

Time frame: Submaximal test during day 2 and day 3.

Peak dyspnea intensity

Dyspnea intensity at peak exercise. 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.

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

Leg fatigue

The Borg's modified 0-10 category ratio scale (Borg CR10) will be used, where 0 represents no perceived leg fatigue at all, and 10 represents maximum leg fatigue ever experienced.

Time frame: During submaximal test, at day 2 and day 3.

Central Contacts

Zainab Ahmadi, MD, PhD

CONTACT

046171000 zainab.ahmadi@med.lu.se

Data from ClinicalTrials.gov

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