Interstitial Lung Disease (ILD)Phase 2Ment-ILDNCT07398287
Efficacy of L-menthol on Breathlessness in Interstitial Lung Disease
A Phase 2 study testing L-menthol in people with Interstitial Lung Disease (ILD), run by Region Skane at 2 sites in Sweden.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease (ILD)
- What is being tested?
- L-menthol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 2 sitesSweden
- Study dates
- 13 Apr 2026to May 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden2 sites, 2 recruiting
- Recruiting
Blekinge Institute of Technology
Karlskrona, Blekinge County
Jacob Sandberg, MD, PhD, +46 (0)455-38 54 09, jacob.sandberg@bth.se
- Recruiting
Lund University hospital and Region Skåne
Lund
Zainab Ahmadi, MD, PhD, 046171000, zainab.ahmadi@med.lu.se
About this study
Official title: Effect of L-menthol on Breathlessness and Exercise Capacity in Interstitial Lung Disease: a Randomized Crossover Trial
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).
Read the 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.
- Conditions
- Interstitial Lung Disease (ILD)
- Being tested
- L-menthol, Placebo
- Keywords
- interstitial lung disease, breathlessness, dyspnea, CPET, exercise
- Medical subject headings
- Lung Diseases, Interstitial, Dyspnea, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
L-mentholDrug
(Sigma-Aldrich, St. Louis, US)
PlaceboOther
Strawberry scent (Sigma-Aldrich, St. Louis, US)
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: L-menthol |
| Placebo | Placebo comparator | For placebo, the patch will contain a similarly patch with strawberry scent. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During submaximal test, at isotime during day 2 and day 3.
Secondary outcomes (15)
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 ever experienced.
Measured: During submaximal test, at iso-time during day 2 and day 3.
Total time
Time to the limit of tolerance (s) (tLIM)
Measured: At the end of submaximal test during day 2 and day 3.
Exercise capacity
V'O2 (aerobic exercise capacity, absolute and in %pred)
Measured: 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.
Measured: During submaximal test, at peak during day 2 and day 3.
Leg fatigue
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.
Measured: During submaximal test at day 2 and day 3.
Ventilatory efficacy
Efficacy of ventilation (VE/V'CO2-slope)
Measured: During submaximal test at day 2 and day 3.
Saturation
O2-Saturation
Measured: During submaximal test at day 2 and day 3.
Stop reason
Causes of stopping the test
Measured: During submaximal test at day 2 and day 3.
Adverse events
Any adverse events during the test
Measured: through study completion, an average of 1 week.
Respiratory exchange ratio
Respiratory exchange ratio (RER), defined as V'CO2/V'O2
Measured: During the submaximal test at day 2 and day 3.
Heart rate
Heart rate in beats/min
Measured: During the submaximal test at day 2 and day 3.
Breathing frequency
Breathing frequency in breaths/min
Measured: During the submaximal test at day 2 and day 3.
Minute ventilation
Minute ventilation
Measured: During the submaximal test at day 2 and day 3.
Tidal volume (VT)
Tidal volume in liters
Measured: During the submaximal test at day 2 and day 3.
Ventilatory reserve
defined as maximal voluntary ventilation (MVV) - VE
Measured: During the submaximal test at day 2 and day 3.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start13 Apr 2026
- Primary completionFeb 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung Disease (ILD)Studies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Multi-center, randomized (ratio 1:1), placebo-controlled, crossover trial (RCT) design
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Blekinge Institute of Technology, Blekingesjukhuset, Karlskrona, Lund University
- Responsible party
- Sponsor
- Investigators
- Zainab Ahmadi, Principal investigator, Region Skåne and Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07398287
- Sponsor's protocol ID
- Ment-ILD
- Acronym
- Ment-ILD
- Status last verified
- Apr 2026
- First submitted
- 13 Jan 2026
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of L-menthol on Breathlessness and Exercise Capacity in Interstitial Lung Disease: a Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT07398287
- Acronym / sponsor ID
- Ment-ILD / Ment-ILD
- Conditions
- Interstitial Lung Disease (ILD)
- Keywords
- interstitial lung disease, breathlessness, dyspnea, CPET, exercise
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Blekinge Institute of Technology, Blekingesjukhuset, Karlskrona, Lund University
- Study start
- 13 Apr 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Multi-center, randomized (ratio 1:1), placebo-controlled, crossover trial (RCT) design
| Arm | Type | Receives |
|---|---|---|
| L-Menthol | Experimental | Drug: L-mentholIn 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 | Other: PlaceboFor placebo, the patch will contain a similarly patch with strawberry scent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| L-menthol(Sigma-Aldrich, St. Louis, US) | Drug | L-Menthol |
| PlaceboStrawberry scent (Sigma-Aldrich, St. Louis, US) | Other | Placebo |
Primary outcome
Breathlessness intensity
Time frame: 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.
15 secondary outcomes
Dyspnea unpleasantness
Time frame: During submaximal test, at iso-time during day 2 and day 3.
Total time
Time frame: At the end of submaximal test during day 2 and day 3.
Exercise capacity
Time frame: Submaximal test during day 2 and day 3.
Peak dyspnea intensity
Time frame: During submaximal test, at peak during day 2 and day 3.
Leg fatigue
Time frame: During submaximal test at day 2 and day 3.
Ventilatory efficacy
Time frame: During submaximal test at day 2 and day 3.
Saturation
Time frame: During submaximal test at day 2 and day 3.
Stop reason
Time frame: During submaximal test at day 2 and day 3.
Adverse events
Time frame: through study completion, an average of 1 week.
Respiratory exchange ratio
Time frame: During the submaximal test at day 2 and day 3.
Heart rate
Time frame: During the submaximal test at day 2 and day 3.
Breathing frequency
Time frame: During the submaximal test at day 2 and day 3.
Minute ventilation
Time frame: During the submaximal test at day 2 and day 3.
Tidal volume (VT)
Time frame: During the submaximal test at day 2 and day 3.
Ventilatory reserve
Time frame: During the submaximal test at day 2 and day 3.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zainab Ahmadi principal investigator
Region Skåne and Lund University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing L-menthol in people with Interstitial Lung Disease (ILD), run by Region Skane at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zainab Ahmadi, MD, PhD (046171000, zainab.ahmadi@med.lu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Breathlessness intensity (time frame: During submaximal test, at isotime during day 2 and day 3.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.