Effect of L-menthol on breathlessness in COPD patients
Effect of L-menthol on Breathlessness and Exercise Capacity in Chronic Obstructive Pulmonary Disease: a Randomized
This study is testing if inhaling L-menthol can help people with COPD feel less breathless.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Region Skane Academic / other |
| Locations | 1 site (Lund) |
| Trial ID | NCT05888597 on ClinicalTrials.gov |
What this trial studies
This study evaluates the impact of inhaled L-menthol on alleviating breathlessness in individuals with chronic obstructive pulmonary disease (COPD). Chronic dyspnea is a significant symptom affecting patients' quality of life, and current treatments are insufficient. The study aims to determine the effectiveness of L-menthol, which may enhance airflow perception through olfactory stimulation, thereby reducing the sensation of breathlessness. Participants will be randomly assigned to receive either L-menthol or a placebo during the trial.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of COPD and significant breathlessness.
Not a fit: Patients with severe comorbid conditions or those requiring supplemental oxygen may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the quality of life for COPD patients by reducing chronic breathlessness.
How similar studies have performed: Preliminary data from pilot studies suggest that inhaled L-menthol may effectively reduce dyspnea in COPD patients, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * The subject has given written consent to participate in the study * Diagnosis of COPD confirmed by spirometry and a FEV1 \< 80% of predicted post bronchodilator at baseline * age 18 years or older * able to cycle * able to understand and talk Swedish to participate in the study procedures, as judged by the Investigator. 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.
Where this trial is running
Lund
- Lund University — Lund, Sweden (Recruiting)
Study contacts
- Principal investigator: Zainab Ahmadi, MD, PhD — Region Skåne
- Study coordinator: Zainab Ahmadi, MD, PhD
- Email: zainab.ahmadi@med.lu.se
- Phone: 046171000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.