Clinical trial NCT05888597: Efficacy of L-menthol on Breathlessness in Chronic Obstructive Pulmonary Disease
Official title: Effect of L-menthol on Breathlessness and Exercise Capacity in Chronic Obstructive Pulmonary Disease: a Randomized
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: Lund University
First posted: 2023-06-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Multi-center, randomized (ratio 1:1), double-blinded, placebo-controlled, crossover trial (RCT) design
Primary purpose: BASIC_SCIENCE

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.

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.

Primary outcomes:
measure: Breathlessness intensity
timeFrame: Through study completion, up to 1 year
Secondary outcomes:
measure: Dyspnea unpleasantness
timeFrame: Through study completion, up to 1 year
measure: Total time
timeFrame: Through study completion, up to 1 year
measure: Exercise capacity
timeFrame: Through study completion, up to 1 year
measure: Work load
timeFrame: Through study completion, up to 1 year
measure: Minute ventilation
timeFrame: Through study completion, up to 1 year
measure: Tidal volume (VT)
timeFrame: Through study completion, up to 1 year
measure: Ventilatory reserve
timeFrame: Through study completion, up to 1 year
measure: Cardiac reserve
timeFrame: Through study completion, up to 1 year
measure: Inspiratory capacity
timeFrame: Through study completion, up to 1 year
measure: Breathing frequency
timeFrame: Through study completion, up to 1 year
measure: Peak dyspnea intensity
timeFrame: Through study completion, up to 1 year
measure: Leg discomfort
timeFrame: Through study completion, up to 1 year
measure: Anaerobic threshold
timeFrame: Through study completion, up to 1 year
measure: Ventilatory efficacy
timeFrame: Through study completion, up to 1 year
measure: Respiratory exchange ratio
timeFrame: Through study completion, up to 1 year
measure: Saturation
timeFrame: Through study completion, up to 1 year
measure: Stop reason
timeFrame: Through study completion, up to 1 year
measure: Adverse events
timeFrame: Through study completion, up to 1 year
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Lund University
Study officials:
affiliation: Region Skåne
name: Zainab Ahmadi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: