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Lignosus Rhinoceros TM02® as a Complementary Therapy for Uncontrolled Asthma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Lignosus Rhinoceros TM02® as a Complementary Therapy for Uncontrolled Asthma

Lignosus Rhinoceros TM02® as a Complementary Therapy for Uncontrolled Asthma: A Prospective, Open-label, Single-arm, Phase II Study

NCT06451328•University of Malaya

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if TM02® works to treat partially controlled or uncontrolled asthma in adults. It will also learn about the efficacy and safety of TM02®. The main questions it aims to answer are: Does TM02® causes bronchodilation (to what extent), improves asthma control, and reduces airway inflammation and blood eosinophils and serum immunoglobulin E levels. Participants will: Take TM02® every day for 90 days. Visit the clinic once every 30 days for checkups, tests and to fill up questionnaires. Keep a diary of their symptoms and the number of times they use a rescue inhaler.

Detailed Description

This 90-day prospective phase II, open label, single-arm study was conducted from March 2022 to February 2023. Subjects with partially controlled or uncontrolled asthma, assessed according to the Global Initiative for Asthma (GINA) guidelines, were enrolled from the outpatient asthma clinic at the Universiti Malaya Medical Centre, Kuala Lumpur, Malaysia. The effects of TM02® on bronchodilation was determined via trough forced expiratory volume in 1 second (FEV1) assessment. Improvement of asthma control was assessed using the Asthma Control Questionnaire-7 (ACQ-7). Serial measurements of fractional exhaled nitric oxide (FeNO) levels at baseline, 30, 60 and 90 days were performed to assess the effectiveness of TM02® in reducing FeNO, a marker of Type 2 airway inflammation. Blood eosinophil count and serum immunoglobulin E (IgE) level were also measured.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Aged 18 years and above with a prior documented diagnosis of asthma by a physician based on the GINA guidelines following these criteria: well-documented requirement for regular treatment with a minimum dose of either fluticasone/salmeterol combination therapy or budesonide/formoterol combination therapy for three months, with a stable dose for one month prior to screening, FEV1 \>35% to \<80% measured during the screening phase (3 attempts maximum) prior to the first dose of TM02®, reversibility of at least 12% and 200 mL in FEV1 after 400 mcg salbutamol during the screening phase, or documented history of reversibility test that met these criteria within 12 months prior to screening.
•No recent exacerbations six weeks prior to enrolment
•Non-smoker for at least one year with a prior tobacco consumption \< 10 pack-years
•Normal organ function; and weigh \> 41 kg with a body mass index (BMI) between 18 and 35 kg/m2.

Exclusion Criteria

•Currently exposed to allergens or triggering factors influencing asthma control
•Pregnant or lactating
•Have chronic obstructive pulmonary disease (COPD) and/or other lung diseases impairing pulmonary function test
•Receiving oral corticosteroids for any other reason than to treat asthma within 6 weeks prior to screening
•Had history of acute sinus infection or respiratory tract infection within 4 weeks prior to screening
•Cardiac disorders which include one of the following conditions: acute coronary syndrome, acute heart failure \[Class III or IV of the New York Heart Association (NYHA) classification\], ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death), cardiac failure class III or IV of the NYHA classification, severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block), syncope with unknown etiology within 3 months, or uncontrolled hypertension.
•Active lung disease other than asthma (eg. chronic bronchitis)
•Had undergone major surgery within 4 weeks prior to screening
•Have a life expectancy of less than 6 months
•Had a history of primary malignancy \< 5 years (except treated basal cell skin cancer or cervical carcinoma in situ)
+5 more criteria

Locations (1)

University of Malaya Medical Centre

Kuala Lumpur, Malaysia

Key Dates

Start Date

March 1, 2022

Primary Completion Date

February 28, 2023

Completion Date

February 28, 2023

Last Updated

June 11, 2024

Enrollment

ACTUAL participants

Conditions

Asthma

Interventions

Lignosus rhinoceros TM02®

DRUG

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Asthma

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RECRUITING

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

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Asthma

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RECRUITINGNA

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 11, 2024Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Lignosus Rhinoceros TM02® as a Complementary Therapy for Uncontrolled Asthma

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

To Assess the Management of Patients on Global Initiative of Asthma (GINA) Step 4 and 5 Treatment in Hong Kong

A Study to Investigate Efficacy and Safety of PT027 Compared With PT007 in Symptomatic Chinese Adults With Asthma