AsthmaPhase 2NCT06451328
Lignosus Rhinoceros TM02® as a Complementary Therapy for Uncontrolled Asthma
A Phase 2 study testing Lignosus rhinoceros TM02® in people with Asthma, run by University of Malaya at 1 site in Malaysia.
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®. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Lignosus rhinoceros TM02®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteMalaysia
- Study dates
- 1 Mar 2022to 28 Feb 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Asthma
- Being tested
- Lignosus rhinoceros TM02®
- Keywords
- asthma, FeNO, FEV1, Lignosus rhinoceros, TM02®
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lignosus rhinoceros TM02®Drug
Lignosus rhinoceros TM02®
| Study group | Role | What they receive |
|---|---|---|
| TM02® | Experimental | 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. Receives: Drug: Lignosus rhinoceros TM02® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in mean trough FEV1 in millilitres from baseline (pre-treatment) to end of the 90-day treatment period
Mean trough FEV1 in millilitres
Measured: 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.
Measured: 90 days
Secondary outcomes (3)
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)
Measured: 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
Measured: 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)
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start1 Mar 2022
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of MalayaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaya
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Poh Mau Ern, University of Malaya
- Investigators
- Mau Ern Poh, MBBS, Principal investigator, University of Malaya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451328
- Sponsor's protocol ID
- 202010239161
- Status last verified
- Jun 2024
- First submitted
- 28 May 2024
- Last updated
- 11 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lignosus Rhinoceros TM02® as a Complementary Therapy for Uncontrolled Asthma: A Prospective, Open-label, Single-arm, Phase II Study
- ClinicalTrials.gov ID
- NCT06451328
- Acronym / sponsor ID
- 202010239161
- Conditions
- Asthma
- Keywords
- asthma, FeNO, FEV1, Lignosus rhinoceros, TM02®
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of MalayaUniversity, hospital or other
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TM02® | Experimental | Drug: Lignosus rhinoceros 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lignosus rhinoceros TM02®Lignosus rhinoceros TM02® | Drug | TM02® |
Primary outcome
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
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.
3 secondary outcomes
Changes in mean FeNO levels in parts per billion (ppb) from baseline to end of the 90-day treatment period
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
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.
Time frame: 90 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mau Ern Poh, MBBS principal investigator
University of Malaya
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Lignosus rhinoceros TM02® in people with Asthma, run by University of Malaya at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in mean trough FEV1 in millilitres from baseline (pre-treatment) to end of the 90-day treatment period (time frame: 90 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2024.