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NCT05785026 | RECRUITING | Dyspnea

Menthol for Dyspnea Relief in Health and COPD
Sponsor:

KU Leuven

Information provided by (Responsible Party):

Daniel Langer

Brief Summary:

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.

Condition or disease

Dyspnea

Chronic Obstructive Pulmonary Disease

Intervention/treatment

Menthol inhalation

Strawberry scent

Phase

NA

Detailed Description:

The project is structured in 4 work packages (WP), each including a different sample of healthy volunteers (WP1, 2) or patients with COPD (WP3, 4), 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).

Study Type : INTERVENTIONAL
Estimated Enrollment : 120 participants
Masking : SINGLE
Primary Purpose : TREATMENT
Official Title : Effectiveness and Mechanisms of Menthol Inhalation for the Relief of Dyspnea in Health and COPD
Actual Study Start Date : 2023-01-01
Estimated Primary Completion Date : 2026-12-31
Estimated Study Completion Date : 2027-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * 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)
Exclusion Criteria
  • * 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
Menthol for Dyspnea Relief in Health and COPD

Location Details

NCT05785026

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

Belgium,

University Hospital Leuven

Leuven, Belgium, 3000