Menthol for Dyspnea Relief in Health and COPD (MENTHODYSC)

Catholic University (KU) of Leuven

Status: Enrolling

Conditions: Dyspnea; Chronic Obstructive Pulmonary Disease

Treatments: Other: Strawberry scent; Other: Menthol inhalation

Study type: Interventional

Funder types: Other

Identifiers

NCT05785026

S66762

Details and patient eligibility

About

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.

Full 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).

Enrollment: 120 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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120 participants in 9 patient groups, including a placebo group

WP 1a

Experimental group

Description:

Menthol inhalation during resistive loaded breathing trials in healthy participants.

Treatment:

Other: Menthol inhalation

WP 1b

Placebo Comparator group

Description:

Strawberry scent during resistive loaded breathing trials in healthy participants.

Treatment:

Other: Strawberry scent

WP 2a

Experimental group

Description:

Menthol inhalation during cycle exercise in healthy participants.

Treatment:

Other: Menthol inhalation

WP 2b

Placebo Comparator group

Description:

Strawberry scent during cycle exercise in healthy participants.

Treatment:

Other: Strawberry scent

WP 3a

Experimental group

Description:

Menthol inhalation during resting breathing in dyspneic COPD participants.

Treatment:

Other: Menthol inhalation

WP 3b

Placebo Comparator group

Description:

Strawberry scent during resting breathing in dyspneic COPD participants.

Treatment:

Other: Strawberry scent

WP 3c

No Intervention group

Description:

Resting breathing in dyspneic COPD participants.

WP 4a

Experimental group

Description:

Menthol inhalation during cycle exercise in COPD participants.

Treatment:

Other: Menthol inhalation

WP 4b

Placebo Comparator group

Description:

Strawberry scent during cycle exercise in COPD participants.

Treatment:

Other: Strawberry scent