Interstitial Lung Disease (ILD)
Conditions
Keywords
interstitial lung disease, breathlessness, dyspnea, CPET, exercise
Brief summary
The purpose of this study is to assess the effect of L-menthol on breathlessness and exercise capacity in patients with Interstitial lung disease (ILD).
Detailed description
Dyspnea is a cardinal symptom in patients with interstitial lung disease (ILD), 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 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 chronic dyspnea in patients with ILD.
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
Lund University
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 fibrosing ILD according to international guidelines * 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 ever 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. | 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. |
| 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. | Minute ventilation |
| Tidal volume (VT) | 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
PRINCIPAL_INVESTIGATORZainab Ahmadi
Region Skåne and Lund University
Outcome results
None listed