Efficacy of L-menthol on Breathlessness in Chronic Obstructive Pulmonary Disease

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— Ment-COPD  

Official title:

Effect of L-menthol on Breathlessness and Exercise Capacity in Chronic Obstructive Pulmonary Disease: a Randomized

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05888597
• Other study ID #: Ment-COPD
• Status: Recruiting
• Phase: Phase 2
• Start date: May 24, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: May 2023
• Source: Region Skane
• Contact: Zainab Ahmadi, MD, PhD
• Phone: 046171000
• Email: zainab.ahmadi[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess the effect of L-menthol on breathlessness in patients with chronic obstructive pulmonary disease (COPD).

Description:

Breathelssness (Dyspnea) is a cardinal symptom in patients with chronic obstructive pulmonary disease (COPD), often triggered by daily-life physical activities. Despite optimal treatment of the underlying disease, many patients still suffer from chronic and disabling dyspnea for many years, leading to exercise intolerance, and worse morbidity and mortality. 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 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 chronic dyspnea in patients with COPD.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: December 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• The subject has given written consent to participate in the study
• Diagnosis of COPD confirmed by spirometry and a FEV1 < 80% of predicted post bronchodilator at baseline
• age 18 years or older
• able to cycle
• able to understand and talk Swedish to participate in the study procedures, as judged by the Investigator.

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Dyspnea
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• L-menthol
(Sigma-Aldrich, St. Louis, US)

Other:
• Placebo
Strawberry scent (Sigma-Aldrich, St. Louis, US)

Locations

Country	Name	City	State
Sweden	Lund University	Lund

Sponsors (2)

Lead Sponsor	Collaborator
Region Skane	Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breathlessness intensity	The difference between treatment conditions in dyspnea intensity (Borg CR10 scale) at iso-time.	Through study completion, up to 1 year
Secondary	Dyspnea unpleasantness	The difference between treatment conditions in dyspnea unpleasantness (Borg CR10 scale) at iso-time.	Through study completion, up to 1 year
Secondary	Total time	Time to the limit of tolerance (s) (tLIM)	Through study completion, up to 1 year
Secondary	Exercise capacity	V'O2 (aerobic exercise capacity, absolute and in %pred)	Through study completion, up to 1 year
Secondary	Work load	Workload (W and %pred)	Through study completion, up to 1 year
Secondary	Minute ventilation	Minute ventilation	Through study completion, up to 1 year
Secondary	Tidal volume (VT)	Tidal volume (VT)	Through study completion, up to 1 year
Secondary	Ventilatory reserve	Ventilatory reserve, defined as maximal voluntary ventilation (MVV) - VE	Through study completion, up to 1 year
Secondary	Cardiac reserve	Cardiac reserve, evaluated using the predicted peak heart rate	Through study completion, up to 1 year
Secondary	Inspiratory capacity	Inspiratory capacity (IC) during exercise	Through study completion, up to 1 year
Secondary	Breathing frequency	Breathing frequency during exercise	Through study completion, up to 1 year
Secondary	Peak dyspnea intensity	Dyspnea intensity at peak exercise (Borg CR10)	Through study completion, up to 1 year
Secondary	Leg discomfort	Leg discomfort (Borg CR10)	Through study completion, up to 1 year
Secondary	Anaerobic threshold	Timing (and V'O2) of the anaerobic threshold (AT)	Through study completion, up to 1 year
Secondary	Ventilatory efficacy	Efficacy of ventilation (VE/V'CO2-slope)	Through study completion, up to 1 year
Secondary	Respiratory exchange ratio	Respiratory exchange ratio (RER), defined as V'CO2/V'O2	Through study completion, up to 1 year
Secondary	Saturation	O2-saturation	Through study completion, up to 1 year
Secondary	Stop reason	Causes of stopping the test	Through study completion, up to 1 year
Secondary	Adverse events	Any adverse events during the test	Through study completion, up to 1 year