Asthma
Conditions
Keywords
breathlessness, asthma, exercise capacity, CPET
Brief summary
The purpose of this study is to assess the effect of L-menthol on breathlessness and exercise capacity in patients with Asthma.
Detailed description
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.
Interventions
DRUGL-menthol
(Sigma-Aldrich, St. Louis, US)
OTHERPlacebo
Strawberry scent (Sigma-Aldrich, St. Louis, US)
Sponsors
Region Skane
Blekinge Institute of Technology
Blekingesjukhuset, Karlskrona
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Caregiver)
Intervention model description
Multi-center, randomized (ratio 1:1), placebo-controlled, crossover trial (RCT) design
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* the subject has given written consent to participate in the study * physician diagnosis of Asthma according to international guidelines * mMRC (modified Medical Research Council) score of 1 or above * age 18 years or older * able to cycle * able to understand and talk Swedish to participate in the study procedures, as judged by the Investigators.
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breathlessness intensity | During submaximal test, at isotime during day 2 and day 3. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dyspnea unpleasantness | During submaximal test, at iso-time during day 2 and day 3 | 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. |
| Total time | At the end of submaximal test during day 2 and day 3. | Time to the limit of tolerance (s) (tLIM) |
| Exercise capacity | Submaximal test during day 2 and day 3. | V'O2 (aerobic exercise capacity, absolute and in %pred) |
| Peak dyspnea intensity | During submaximal test, at peak during day 2 and day 3. | 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. |
| Leg fatigue | During submaximal test, at day 2 and day 3. | 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. |
| Ventilatory efficacy | During submaximal test, at day 2 and day 3. | Efficacy of ventilation (VE/V'CO2-slope) |
| Saturation | During submaximal test, at day 2 and day 3. | O2-Saturation |
| Stop reason | During submaximal test, at day 2 and day 3. | Causes of stopping the test |
| Adverse events | Through study completion, an average of 1 week. | Any adverse events during the test |
| Respiratory exchange ratio | During the submaximal test at day 2 and day 3. | Respiratory exchange ratio (RER), defined as V'CO2/V'O2 |
| Heart rate | During the submaximal test at day 2 and day 3. | Heart rate in beats/min |
| Breathing frequency | During the submaximal test at day 2 and day 3. | Breathing frequency in breaths/min |
| Minute ventilation | During the submaximal test at day 2 and day 3. | Ventilation per minute |
| Tidal volume | During the submaximal test at day 2 and day 3. | Tidal volume in liters |
| Ventilatory reserve | During the submaximal test at day 2 and day 3. | Defined as maximal voluntary ventilation (MVV) - VE |
Countries
Sweden
Contacts
CONTACTZainab Ahmadi, MD, PhD
Outcome results
None listed