Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Blekinge Institute of Technology | OTHER |
| Blekingesjukhuset, Karlskrona | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to assess the effect of L-menthol on breathlessness and exercise capacity in patients with Asthma.
Dyspnea is a cardinal symptom in patients with lung disease, often triggered by daily-life physical activities. 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 and ILD 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 patients with Asthma.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| L-menthol | Experimental | In the trial, prior to performing submaximal cardio-pulmonary exercise testing (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. |
|
| Placebo | Placebo Comparator | For placebo, the patch will contain a similarly patch with strawberry scent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L-menthol | Drug | (Sigma-Aldrich, St. Louis, US) |
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Breathlessness intensity | The difference between treatment conditions in dyspnea intensity at iso-time. The Borg's modified 0-10 category ratio scale (Borg CR10) will be used, where 0 represents no perceived breathlessness at all, and 10 represents maximum breathlessness intensity ever experienced. | During submaximal test, at isotime during day 2 and day 3. |
| Measure | Description | Time Frame |
|---|---|---|
| Dyspnea unpleasantness | The difference between treatment conditions in dyspnea unpleasantness at iso-time. The Borg's modified 0-10 category ratio scale (Borg CR10) will be used, where 0 represents no perceived unpleasantness at all, and 10 represents maximum breathlessness unpleasantness experienced. | During submaximal test, at iso-time during day 2 and day 3 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zainab Ahmadi, MD, PhD | Contact | 046171000 | zainab.ahmadi@med.lu.se |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Blekinge Institute of Technology | Karlskrona | Blekinge County | Sweden | |||
| Lund University hospital and Region Skåne |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001249 | Asthma |
| D004417 | Dyspnea |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D008610 | Menthol |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
Not provided
Not provided
Multi-center, randomized (ratio 1:1), placebo-controlled, crossover trial (RCT) design
Not provided
Not provided
Not provided
| Other |
Strawberry scent (Sigma-Aldrich, St. Louis, US) |
|
| Total time | Time to the limit of tolerance (s) (tLIM) | At the end of submaximal test during day 2 and day 3. |
| Exercise capacity | V'O2 (aerobic exercise capacity, absolute and in %pred) | Submaximal test during day 2 and day 3. |
| Peak dyspnea intensity | Dyspnea intensity at peak exercise. The Borg's modified 0-10 category ratio scale (Borg CR10) will be used, where 0 represents no perceived breathlessness at all, and 10 represents maximum breathlessness intensity ever experienced. | During submaximal test, at peak during day 2 and day 3. |
| Leg fatigue | The Borg's modified 0-10 category ratio scale (Borg CR10) will be used, where 0 represents no perceived leg fatigue at all, and 10 represents maximum leg fatigue ever experienced. | During submaximal test, at day 2 and day 3. |
| Ventilatory efficacy | Efficacy of ventilation (VE/V'CO2-slope) | During submaximal test, at day 2 and day 3. |
| Saturation | O2-Saturation | During submaximal test, at day 2 and day 3. |
| Stop reason | Causes of stopping the test | During submaximal test, at day 2 and day 3. |
| Adverse events | Any adverse events during the test | Through study completion, an average of 1 week. |
| Respiratory exchange ratio | Respiratory exchange ratio (RER), defined as V'CO2/V'O2 | During the submaximal test at day 2 and day 3. |
| Heart rate | Heart rate in beats/min | During the submaximal test at day 2 and day 3. |
| Breathing frequency | Breathing frequency in breaths/min | During the submaximal test at day 2 and day 3. |
| Minute ventilation | Ventilation per minute | During the submaximal test at day 2 and day 3. |
| Tidal volume | Tidal volume in liters | During the submaximal test at day 2 and day 3. |
| Ventilatory reserve | Defined as maximal voluntary ventilation (MVV) - VE | During the submaximal test at day 2 and day 3. |
| Lund |
| Sweden |
|
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D012120 | Respiration Disorders |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Organic Chemicals |
| D000081005 | Cyclohexane Monoterpenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D039821 | Monoterpenes |
| D013729 | Terpenes |
| D008055 | Lipids |