Efficacy of L-menthol on Breathlessness in Asthma
ConditionAsthma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegion Skane
About this trial
The purpose of this study is to assess the effect of L-menthol on breathlessness and exercise capacity in patients with Asthma.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Crossover
Treatments tested in this trial
L-menthol
Drug(Sigma-Aldrich, St. Louis, US)
Placebo
Other interventionStrawberry scent (Sigma-Aldrich, St. Louis, US)
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: L-mentholExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
During submaximal test, at isotime during day 2 and day 3.Secondary outcomes
1
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.
Time frame
During submaximal test, at iso-time during day 2 and day 32
Total time
Time to the limit of tolerance (s) (tLIM)
Time frame
At the end of submaximal test during day 2 and day 3.3
Exercise capacity
V'O2 (aerobic exercise capacity, absolute and in %pred)
Time frame
Submaximal test during day 2 and day 3.4
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.
Time frame
During submaximal test, at peak during day 2 and day 3.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Region Skane
Lead sponsor
Blekinge Institute of Technology
Collaborator
Blekingesjukhuset, Karlskrona
Collaborator
Source ClinicalTrials.gov