Lignosus Rhinoceros TM02® as a Complementary Therapy for Uncontrolled Asthma

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06451328
• Other study ID #: 202010239161
• Status: Completed
• Phase: Phase 2
• Start date: March 1, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: June 2024
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

• Had any severe and/or uncontrolled medical condition aside from asthma

• Has human immunodeficiency virus (HIV) infection

• Had a history of poor compliance or drug/alcohol abuse,

• Had participated in a clinical study with exposure to any non-registered drug or botanical product within 30 days prior

• Had a condition that would interfere with their ability to provide informed consent, comply with the study protocol, or put the person in undue risk.

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Lignosus rhinoceros TM02®
Lignosus rhinoceros TM02®

Locations

Country	Name	City	State
Malaysia	University of Malaya Medical Centre	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in mean trough FEV1 in millilitres from baseline (pre-treatment) to end of the 90-day treatment period	Mean trough FEV1 in millilitres	90 days
Primary	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.	90 days
Secondary	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)	90 days
Secondary	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	90 days
Secondary	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)	90 days