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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
17
Lignosus rhinoceros TM02®
University of Malaya Medical Centre
Kuala Lumpur, Malaysia
Changes in mean trough FEV1 in millilitres from baseline (pre-treatment) to end of the 90-day treatment period
Mean trough FEV1 in millilitres
Time frame: 90 days
Mean change in Asthma Control Questionnaire -7 (ACQ - 7) scores from baseline (pre-treatment) to end of the 90-day treatment period
The ACQ-7 consists of 6 questions about asthma symptoms during the previous week, each of which is scored on a range from 0 (no impairment) to 6 (maximum impairment), and an assessment of FEV1. The minimal clinically important difference (MCID) is 0.5 units.
Time frame: 90 days
Changes in mean FeNO levels in parts per billion (ppb) from baseline to end of the 90-day treatment period
Mean FeNO in parts per billion (ppb)
Time frame: 90 days
Changes in mean blood eosinophil count in cells per decilitre (cells/dL) from baseline to end of the 90-day treatment period
Mean blood eosinophil count in cells per decilitre
Time frame: 90 days
Changes in mean serum immunoglobulin E level in International units per millilitre (IU/ml) from baseline (pre-treatment) to end of the 90-day treatment period.
Mean serum immunoglobulin E level in International unit per millilitre (IU/ml)
Time frame: 90 days
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