Efficacy of L-menthol on Breathlessness in Asthma

Официальное название

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

Обзор

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

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• Breathlessness intensity [Срок оценки: During submaximal test, at isotime during day 2 and day 3.]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Фундаментальное исследование

Центры проведения

Швеция · 2 центра

• Blekinge Institute of Technology — Karlskrona
• Lund University hospital and Region Skåne — Lund

Идентификаторы

NCT: NCT07500974 · Ment-Astma

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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