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Not yet recruiting NCT07500974

Efficacy of L-menthol on Breathlessness in Asthma

Phase II Interventional Asthma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: L-menthol, Placebo.
Who it may be relevant to
Registry conditions: Asthma. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effect of L-menthol on Breathlessness and Exercise Capacity in Asthma: a Randomized Crossover Trial

Overview

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

Detailed 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.

Interventions

  • Drug L-menthol
    (Sigma-Aldrich, St. Louis, US)
  • Other Placebo
    Strawberry scent (Sigma-Aldrich, St. Louis, US)

Primary outcome measures

  • Breathlessness intensity [Time frame: During submaximal test, at isotime during day 2 and day 3.]
Secondary outcome measures (12)
  • Dyspnea unpleasantness [Time frame: During submaximal test, at iso-time during day 2 and day 3]
  • Total time [Time frame: At the end of submaximal test during day 2 and day 3.]
  • Exercise capacity [Time frame: Submaximal test during day 2 and day 3.]
  • Peak dyspnea intensity [Time frame: During submaximal test, at peak during day 2 and day 3.]
  • Leg fatigue [Time frame: During submaximal test, at day 2 and day 3.]
  • Ventilatory efficacy [Time frame: During submaximal test, at day 2 and day 3.]
  • Saturation [Time frame: During submaximal test, at day 2 and day 3.]
  • Stop reason [Time frame: During submaximal test, at day 2 and day 3.]
  • Adverse events [Time frame: Through study completion, an average of 1 week.]
  • Respiratory exchange ratio [Time frame: During the submaximal test at day 2 and day 3.]
  • Heart rate [Time frame: During the submaximal test at day 2 and day 3.]
  • Breathing frequency [Time frame: During the submaximal test at day 2 and day 3.]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Basic science

Study locations

Sweden · 2 centers
  • Blekinge Institute of Technology — Karlskrona
  • Lund University hospital and Region Skåne — Lund

Identifiers

NCT: NCT07500974 · Ment-Astma

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗