search
Back to results

Efficacy of L-menthol on Breathlessness in Chronic Obstructive Pulmonary Disease (Ment-COPD)

Primary Purpose

Chronic Obstructive Pulmonary Disease (COPD)

Status
Not yet recruiting
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
L-menthol
Placebo
Sponsored by
Region Skane
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Lund University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Menthol

Placebo

Arm Description

In the trial, 30 minutes prior to performing submaximal CPET, participants will be administered, L-menthol patch which will be attached to the inside of a facemask that is connected to the breathing circuit.

For placebo, the patch will contain a similarly patch with strawberry scent.

Outcomes

Primary Outcome Measures

Breathlessness intensity
The difference between treatment conditions in dyspnea intensity (Borg CR10 scale) at iso-time.

Secondary Outcome Measures

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

Full Information

First Posted
May 2, 2023
Last Updated
May 24, 2023
Sponsor
Region Skane
Collaborators
Lund University
search

1. Study Identification

Unique Protocol Identification Number
NCT05888597
Brief Title
Efficacy of L-menthol on Breathlessness in Chronic Obstructive Pulmonary Disease
Acronym
Ment-COPD
Official Title
Effect of L-menthol on Breathlessness and Exercise Capacity in Chronic Obstructive Pulmonary Disease: a Randomized
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 24, 2023 (Anticipated)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
December 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Skane
Collaborators
Lund University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Model Description
Single-center, randomized (ratio 1:1), double-blinded, placebo-controlled, crossover trial (RCT) design
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Menthol
Arm Type
Experimental
Arm Description
In the trial, 30 minutes prior to performing submaximal CPET, participants will be administered, L-menthol patch which will be attached to the inside of a facemask that is connected to the breathing circuit.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
For placebo, the patch will contain a similarly patch with strawberry scent.
Intervention Type
Drug
Intervention Name(s)
L-menthol
Intervention Description
(Sigma-Aldrich, St. Louis, US)
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Strawberry scent (Sigma-Aldrich, St. Louis, US)
Primary Outcome Measure Information:
Title
Breathlessness intensity
Description
The difference between treatment conditions in dyspnea intensity (Borg CR10 scale) at iso-time.
Time Frame
Through study completion, up to 1 year
Secondary Outcome Measure Information:
Title
Dyspnea unpleasantness
Description
The difference between treatment conditions in dyspnea unpleasantness (Borg CR10 scale) at iso-time.
Time Frame
Through study completion, up to 1 year
Title
Total time
Description
Time to the limit of tolerance (s) (tLIM)
Time Frame
Through study completion, up to 1 year
Title
Exercise capacity
Description
V'O2 (aerobic exercise capacity, absolute and in %pred)
Time Frame
Through study completion, up to 1 year
Title
Work load
Description
Workload (W and %pred)
Time Frame
Through study completion, up to 1 year
Title
Minute ventilation
Description
Minute ventilation
Time Frame
Through study completion, up to 1 year
Title
Tidal volume (VT)
Description
Tidal volume (VT)
Time Frame
Through study completion, up to 1 year
Title
Ventilatory reserve
Description
Ventilatory reserve, defined as maximal voluntary ventilation (MVV) - VE
Time Frame
Through study completion, up to 1 year
Title
Cardiac reserve
Description
Cardiac reserve, evaluated using the predicted peak heart rate
Time Frame
Through study completion, up to 1 year
Title
Inspiratory capacity
Description
Inspiratory capacity (IC) during exercise
Time Frame
Through study completion, up to 1 year
Title
Breathing frequency
Description
Breathing frequency during exercise
Time Frame
Through study completion, up to 1 year
Title
Peak dyspnea intensity
Description
Dyspnea intensity at peak exercise (Borg CR10)
Time Frame
Through study completion, up to 1 year
Title
Leg discomfort
Description
Leg discomfort (Borg CR10)
Time Frame
Through study completion, up to 1 year
Title
Anaerobic threshold
Description
Timing (and V'O2) of the anaerobic threshold (AT)
Time Frame
Through study completion, up to 1 year
Title
Ventilatory efficacy
Description
Efficacy of ventilation (VE/V'CO2-slope)
Time Frame
Through study completion, up to 1 year
Title
Respiratory exchange ratio
Description
Respiratory exchange ratio (RER), defined as V'CO2/V'O2
Time Frame
Through study completion, up to 1 year
Title
Saturation
Description
O2-saturation
Time Frame
Through study completion, up to 1 year
Title
Stop reason
Description
Causes of stopping the test
Time Frame
Through study completion, up to 1 year
Title
Adverse events
Description
Any adverse events during the test
Time Frame
Through study completion, up to 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zainab Ahmadi, MD, PhD
Phone
046171000
Email
zainab.ahmadi@med.lu.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zainab Ahmadi, MD, PhD
Organizational Affiliation
Region Skåne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lund University
City
Lund
Country
Sweden
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zainab Ahmadi, MD, PhD
First Name & Middle Initial & Last Name & Degree
Zainab Ahmadi, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs