臨床研究等提出・公開システム

Effects of olfactory stimulation by L-menthol on dyspnea on exertion in chronic lung disease: A pilot study

Effects of olfactory stimulation by L-menthol on dyspnea on exertion in chronic lung disease: A pilot study

34

COPD (n = 17): sex male 17, Age 75.5 +- 11.2years, Height 166.7 +- 4.6cm, Weight 67.1 +- 8.2kg, %VC 97.7 +- 22.9%, %FEV1 56.0 +- 23.9%. Idiopathic interstitial pneumonias (IIPs) (n= 17): sex male 16, Age 72.1 +- 8.3years, Height 168.4 +- 6.7cm, Weight 72.7 +- 12.0kg, %VC 77.0 +- 5.3%, %FEV1 79.5 +- 19.4%.

All patients 39 excluded 5 (COPD exacerbation 1, olfactory disorder 1, exacerbation of comorbidities 1, and withdrawal of consent 2) patients enrolled 34 (COPD 17 / IIPs 17)

No serious illnesses occurred. Although not causally related, worsening of comorbid hemorrhoids after consent was obtained and falls during walking tests without L-menthol were observed.

The primary endpoint, modified Borg scale (dyspnea) after a 6-minute walk test, was not significantly different between with and without L-menthol olfactory stimulation (COPD group, 4.7 +- 2.7 vs. 5.2 +- 3.1, P = 0.13; IIPs group, 3.4 +- 2.5 vs. 3.9 +- 2.9, P = 0.12, respectively). On the other hand, in patients with COPD, L- menthol olfactory stimulation significantly reduced mental breathing effort, hyperpnoea assessed by the MDP (Multidimensional Dyspnea Profile), and Rapid, Tight chest, Grasping, and Air hunger assessed by the words of dyspnea questionnaire. Other items, such as Physical breathing effort, Air hunger, Tight chest, Mental breathing effort, Unpleasantness, Depression, Anxiety, Frustration, Anger, Fear assessed by MDP, and Expiratory difficulty, Unsatisfied inspiration, Increased work/effort, shallow, Suffocating, Pain, Stops assessed by the words of dyspnea questionnaire were not significantly different. In patients with IIPs, L-menthol olfactory stimulation significantly reduced hyperpnoea assessed by the MDP. Other items, such as Physical breathing effort, Air hunger, Tight chest, Mental breathing effort, Unpleasantness, Depression, Anxiety, Frustration, Anger, Fear assessed by MDP, and Rapid, Expiratory difficulty, Unsatisfied inspiration, Tight chest, Graqsping, Increased work/effort, Air hunger, Shallow, Suffocating, Pain, Stops assessed by the words of dyspnea questionnaire were not significantly different. The results of the measurements of secondary endpoints other than the above were as follows: SpO2 before 6MWT was 95.8 +- 1.1%, SpO2 after 6MWT was 86.2 +- 6.3%, pulse rate before 6MWT was 79.4 +- 12.9 bpm, pulse rate after 6MWT was 114.3 +- 15.5 bpm, 6-minute walking distance was 455.9 +- 95.8 m, grip strength was 35.6 +- 5.7 kg, quadriceps muscle strength 35.0 +- 10.5 kgf, maximal inspiratory pressure 73.6 +- 20.7 cmH2O, maximal expiratory pressure 96.1 +- 33.5 cmH2O, mean daily steps 4968.5 +- 2881.6 steps/day, SGRQ (total) 32.9 +- 16.9 points, NRADL was 84.7 +- 15.6 points. No additional analyses were performed for secondary endpoints other than those listed above, because no improvement was observed in the primary endpoint (modified Borg scale).

Patients first underwent a normal 6-minute walking test (6MWT) without L-menthol olfactory stimulation, followed by a 6MWT with L-menthol olfactory stimulation to verify the difference in dyspnea. The results showed no significant difference in the modified Borg scale between with and without L-menthol olfactory stimulation . In contrast, L-menthol olfactory stimulation reduced dyspnea in some of the MDP and words of dyspnea questionnaire (e.g., Rapid, Tight chest, Grasping, Air hunger).

Sept. 30, 2024

No

none

https://jrct.niph.go.jp/latest-detail/jRCTs031200400

Sakao Seiichiro

Chiba University Hospital

1-8-1 Inohana Chuo-ku, Chiba-shi

sakaos@faculty.chiba-u.jp

Inagaki Takeshi

Chiba Prefectual University of Health Sciences

645-1, Nitona, Chuo-ku, Chiba-shi

+81-43-305-2184

takeshi.inagaki_19@cpuhs.ac.jp

Complete

Mar. 05, 2021

Interventional

single arm study

open(masking not used)

no treatment control/standard of care control

single assignment

treatment purpose

1) Patients with COPD or IIPs who are attending a respiratory medicine in our hosuital
2) Patients who are 20 years of age or older at the time of obtaining consent
3) Patients who are able to walk independently
4) Patients who can accurately perform respiratory function tests and 6MWT
5) Patients whose condition is stable and who have not changed their treatment for more than three months
6) Patients who have been fully informed of the contents of this study and have given written consent
7) Patients who are in or have completed an outpatient rehabilitation program, have stable symptoms, and are not scheduled for an outpatient rehabilitation program during this study

1) Patients with severe orthopedic or central nervous system disease who need assistance with daily living
2) Patients who have been hospitalized for an exacerbation of an primary disease within the past six months
3) Patients with unstable cardiac disease
4) Patients with a history of other serious lung diseases such as occupational lung, sarcoidosis, airway hypersensitivity, malignant diseases, or lung infections caused by immunodeficiency
5) Patients with nasal obstruction and olfactory disturbances
6) Patients who are judged by the principal investigator/assistant physician to have a risk of compromising patient safety or to have difficulty complying with the protocol

Both

Chronic obstructive pulmonary disease, Idiopathic interstitial pneumonias

Aroma seals coated with L-menthol are applied to a surgical mask and the mask is worn for a walking test.

chronic respiratory failure

L-menthol

modified Borg Scale before and after 6-minute walking test

SpO2 (before and after 6MWT)
Pulse rate (before and after 6MWT)
6 minute walking distance
St. George`s Respiratory Questionnaire (SGRQ)
Steps/day
Nagasaki University Respiratory ADL Questionnaire (NRADL)
Quadriceps force
Grip force
Respiratory muscle force (PImax/PEmax)
pulmonary function
Dyspnea Language Questionnaire
Multidimensional Dyspnea Profile
Adverse event

+81-43-226-2616

Feb. 03, 2021

none