Menthol for Dyspnea Relief in Health and COPD

Официальное название

Effectiveness and Mechanisms of Menthol Inhalation for the Relief of Dyspnea in Health and COPD

Обзор

Menthol inhalation (MI) is a novel and promising treatment option for acute relief of dyspnea, however, the underlying ventilatory and/or neural related mechanisms for this relief in symptoms remain unknown. The overall aim of this research project is to systematically examine the mechanisms of dyspnea relief from MI in healthy individuals and those with COPD.

Подробное описание

The project is structured in 5 work packages (WP), each including a different sample of healthy volunteers (WP1, 2) or patients with COPD (WP3, 4, 5), respectively with a 1:1 female/male ratio in each WP. Each WP will be single-blind, placebo-controlled cross-over trial to investigate the effects of MI compared to placebo in healthy volunteers during resistive loaded breathing (WP1), in healthy volunteers during cycling exercise (WP2), in people with COPD who have dyspnea at rest (WP3), and in people with COPD during cycling exercise (WP4, 5).

Вмешательства

• Другое Menthol inhalation
  300 milligrams of L-menthol will be deposited on to a cellulose swab and secured inside the lower portion of a sealed facemask.
• Другое Strawberry scent
  600 microliters of 100% natural strawberry flavoring will be deposited onto on to a cellulose swab and secured inside the lower portion of a sealed facemask.
• Другое Menthol inhalation and facial airflow
  Menthol will be administered using a noseplug and facial airflow will be applied with a tabletop fan.
• Другое Strawberry scent and airflow to leg
  Strawberry will be administered using a noseplug and airflow to the leg will be applied with a tabletop fan.
• Другое Menthol inhalation and airflow to leg
  Menthol will be administered using a noseplug and airflow to the leg will be applied with a tabletop fan.
• Другое Strawberry inhalation and facial airflow
  Strawberry will be administered using a noseplug and facial airflow will be applied with a tabletop fan.

Первичные конечные точки

• Difference in respiratory-related evoked potentials (RREP) with menthol vs. strawberry. [Срок оценки: 1 week]

Критерии участия

Критерии включения

• Age: 18 years of age or older
• Able to speak, read, and write Dutch or English
• Normal pulmonary function: forced expiratory volume in 1 second (FEV1) to forced vital capacity ratio>0.70; FEV1≥80%predicted (WP1 and 2 only)
• Non-smoker or former smokers (smoke-free ≥12 months prior to enrolment) (WP1 and 2 only)
• Clinically stable COPD (based on clinical judgment of the study physician that have not had exacerbations requiring escalation of medical therapy (i.e., short course of oral corticosteroids or antibiotics) within the preceding 14 days (WP3 and 4 only)

Критерии исключения

• Contraindication to exercise testing (e.g., significant cardiovascular, musculoskeletal, neurological disease; see Table 4 from ERS/ATS consensus statement)
• Significant pulmonary or extra-pulmonary disease that, based on clinical assessment, could influence dyspnea and/or impair exercise capacity (with the exception of COPD in WP3 and 4)
• Body mass index <18.5 or >35 kg/m2
• An ulcer or tumor in the esophagus, a nasal septum deviation, or recent nasopharyngeal surgery
• Severe facial trauma including cribriform plate disruption (bone separating brain from nasal cavity)
• Allergies to latex and sensitivities to local anesthetics
• Inability to give informed consent, including those with significant cognitive impairment
• Alcohol consumption within 12 hours of study visit
• Current smoker\*
• History of early menopause (age <45 years)
• Pregnancy or desire to become pregnant while in trial

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• University Hospital Leuven — Leuven

Публикации

• Schaeffer MR, Vanden Bossche L, Beckers K, Verbeke K, Janssens W, Jensen D, Arnold JI, von Leupoldt A, Langer D. Inhaled Menthol for Dyspnea Relief During Cycle Exercise in COPD: A Randomized Trial. Chest. 2025 Aug;168(2):390-401. doi: 10.1016/j.chest.2025.03.002. Epub 2025 Mar 13. PMID 40088943

Идентификаторы

NCT: NCT05785026 · S66762

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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