Lignosus Rhinoceros TM02® as a Complementary Therapy for Uncontrolled Asthma

June 7, 2024 updated by: Poh Mau Ern, University of Malaya

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
17

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • University of Malaya Medical Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: TM02®
Two capsules of TM02®, once daily after meals (breakfast or dinner), totaling 600 mg TM02® daily for 30 days. Subsequently, two capsules of 300 mg TM02®, twice a day after breakfast and dinner daily, totaling 1200 mg TM02® daily for an additional 60 days.
Drug: Lignosus rhinoceros TM02®
Lignosus rhinoceros TM02®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in mean trough FEV1 in millilitres from baseline (pre-treatment) to end of the 90-day treatment period
Time Frame: 90 days
Mean trough FEV1 in millilitres
90 days
Mean change in Asthma Control Questionnaire -7 (ACQ - 7) scores from baseline (pre-treatment) to end of the 90-day treatment period
Time Frame: 90 days
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in mean FeNO levels in parts per billion (ppb) from baseline to end of the 90-day treatment period
Time Frame: 90 days
Mean FeNO in parts per billion (ppb)
90 days
Changes in mean blood eosinophil count in cells per decilitre (cells/dL) from baseline to end of the 90-day treatment period
Time Frame: 90 days
Mean blood eosinophil count in cells per decilitre
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.
Time Frame: 90 days
Mean serum immunoglobulin E level in International unit per millilitre (IU/ml)
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Malaya

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Mau Ern Poh, MBBS, Universiti Malaya

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 28, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 28, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 11, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 11, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 202010239161

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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