Chronic Lower Respiratory DiseasesNCT06690203
Evaluation of the Safety and Clinical Efficacy of NRICM102 in Patients With Chronic Lower Respiratory Tract Diseases
A study testing NRICM102 in people with Chronic Lower Respiratory Diseases, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
This study is to assess safety and efficacy of NRICM102 decoction in participants with CLRD. This study will be conducted in 70 participants. The study consists of 3 periods: a 4-week screening period, a treatment period for at least 12 weeks up to 24 weeks. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Lower Respiratory Diseases
- What is being tested?
- NRICM102
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 30 Sep 2024to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Age ≥18 years of age
- Diagnosed of chronic lower respiratory tract disorder(such as : asthma, COPD, emphysema, chronic bronchitis, bronchiectasis, lung fibrosis) by pulmonologist
- Have symptom of chronic cough, cough with sputum after using of a maintenance respiratory medication and stable disease more than 3 months.
- Willing to be evaluated by a Traditional Chinese Physician whether use of NRICM102 is suitable.
- The patient can use NRICM102 therapy after Traditional Chinese Physician evaluate. Able to understand and sign an informed consent ( or have a legal representative who is able to do so)
Who cannot join
- Females who are breastfeeding or pregnant at screening.
- Life threatening (e.g. intensive care admission and/or use of mechanical ventilation) respiratory failure event in the past 3 months.
- Patients with gastrointestinal malabsorption or condition that might affect the absorption of NRICM102 in the opinion of investigator. (exp: Irritable bowel syndrome, acute gastritis, duodenal ulcer..).
- Acute exacerbation or unstable vital signs on screening stage.
- Patient who have malignancy and receiving chemotherapy/ target therapy at screening.
- Diagnosis of liver cirrhosis or active hepatitis infection.
- Patient having renal dysfunction with Creatinine Clearance Calculator (CCR) < 30mL/min.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Taiwan1 site
Taichung Veterans General Hospita
Taichung, No.1650, Taiwan Boulevard Sect. 4, 40705
About this study
Official title: TaichungVGH Taichung Veterans General Hospital
This study is to assess safety and efficacy of NRICM102 decoction in participants with CLRD. This study will be conducted in 70 participants. The study consists of 3 periods: a 4-week screening period, a treatment period for at least 12 weeks up to 24 weeks.
Read the detailed description
- Investigational product(s)： NRICM102 Decoction
- Development Phase: A real-world Prospective study
- Study Design：
- Experimental Group: Standard of care combined NRICM102 for 12weeks
- Blinding：Open
- Randomization: No
- Parallel design : Not applicable
- Treatment Period：12 to 24 weeks by groups
- Study Period: From 01/07/2024 to 31/12/2025
- Dose adjustment： Not applicable
- Study location： Single
- Study Procedures： This study is to assess safety and efficacy of NRICM102 decoction in participants with CLRD. This study will be conducted in 70 participants. The study consists of 3 periods: a 4-week screening period, a treatment period for at least 12 weeks up to 24 weeks. In principle, the two groups are divided into 1:1. The study group period is divided into a continuous treatment group and a discontinued treatment group. The purpose is to evaluate the drug safety of continuous treatment for 24 weeks and the similarities and differences in the physiological assessment of the subjects between the two groups, so as to serve as a reference for the design of a combined treatment program of traditional Chinese and Western medicine for chronic respiratory diseases. Since subjects may terminate early during the taking period, we also designed an evaluation time point, and also conducted an evaluation at the early end of time (EOS).
- Statistical Methods：
- Main study Hypothesis：Not applicable
- Estimated Sample Size：This study will be conducted in 70 participants. 50 subjects can be evaluated in the trial.
- Efficacy assessment group：Intent-to-treat (ITT)
- Interim analysis：No
- Statistical methods： All participants who have been randomized to study intervention and who have received at least one dose of study intervention will be included in the Efficacy Analysis Set. The Safety Analysis Set is defined as all participants who have been randomized to study intervention.
All results will be presented by treatment with descriptive statistics appropriate to the nature of the variables. Demographic and baseline characteristics will be presented as follows; for continuous variables, the number of non-missing observations, mean, standard deviation (SD), standard error (SE) of the mean, 95% confidence interval (CI) of the mean (except safety data), median, first and third quartiles, minimum and maximum, will be presented; for categorical variables: counts (n) and percentages (%) (where specified) will be presented. These summaries will be provided by time point of assessment as appropriate.
Details on the handling of missing data for the safety or efficacy analyses will be provided.
- Safety will be assessed by descriptive analysis of vital signs, ECGs, laboratory assessments and AEs reported.
- Change from baseline in health related QOL questionnaires ACT, ACQ-5, CAT, SGRQ and mMRC, spirometry and walking distance of visit and average over the treatment period will be reported, and subgroup analysis in CLRT will be provided at Weeks 4, 12, 24 and average over the treatment period.
- 6. Handling of Missing Data： The missing data will not be included in the analysis.
- Conditions
- Chronic Lower Respiratory Diseases
- Being tested
- NRICM102
- Keywords
- Chronic lower respiratory diseases, NRICM102, Inflammation, safety, Biomarkers
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NRICM102Combination product
A traditional Chinese medicine formula
| Study group | Role | What they receive |
|---|---|---|
| A. Combining NRICM102 decoction with standard treatment for 12 weeks | Other | Combining NRICM102 decoction with standard treatment for 12 weeks Receives: Combination Product: NRICM102 |
| B. Combining NRICM102 decoction with standard treatment for 24 weeks | Other | Combining NRICM102 decoction with standard treatment for 24 weeks Receives: Combination Product: NRICM102 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety of combining NRICM102 decoction with standard treatment for 12 to 24 weeks in subjects comorbid with chronic respiratory diseases to treat the chronic respiratory symptoms
The proportion of AE and/or SAE with grading.
Measured: Up to study completion approximately 24 weeks
Secondary outcomes (6)
Asthma control test (ACT) for asthma patients among different treatment periods (12 or 24 weeks)
Measured: Up to study completion approximately 24 weeks
Asthma Control Questionnaire (ACQ)-5 for asthma patients among different treatment periods (12 or 24 weeks)
Measured: Up to study completion approximately 24 weeks
The COPD Assessment Test (CAT) among different treatment periods (12 or 24 weeks)
Measured: Up to study completion approximately 24 weeks
St. George's Respiratory Questionnaire (SGRQ) among different treatment periods (12 or 24 weeks)
St. George's Respiratory Questionnaire (SGRQ)
Measured: Up to study completion approximately 24 weeks
modified Medical Research Council (mMRC) scale among different treatment periods (12 or 24 weeks)
modified Medical Research Council (mMRC) scale
Measured: Up to study completion approximately 24 weeks
Body Constitution Questionnaire (BCQ) in traditional Chinese medicine among different treatment periods (12 or 24 weeks)
Body Constitution Questionnaire (BCQ) in traditional Chinese medicine
Measured: Up to study completion approximately 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2024
- Study start30 Sep 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Lower Respiratory DiseasesStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pin-Kuei Fu, MD, PhD, Taichung Veterans General Hospital
- Investigators
- Pin-Kuei Fu, Principal investigator, chairman; Integrated Care Center of Interstitial Lung Disease (ICCILD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06690203
- Sponsor's protocol ID
- CF24327B
- Status last verified
- Nov 2024
- First submitted
- 15 Oct 2024
- Last updated
- 15 Nov 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 15 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TaichungVGH Taichung Veterans General Hospital
- ClinicalTrials.gov ID
- NCT06690203
- Acronym / sponsor ID
- CF24327B
- Conditions
- Chronic Lower Respiratory Diseases
- Keywords
- Chronic lower respiratory diseases, NRICM102, Inflammation, safety, Biomarkers
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Nov 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.
This study is to assess safety and efficacy of NRICM102 decoction in participants with CLRD. This study will be conducted in 70 participants. The study consists of 3 periods: a 4-week screening period, a treatment period for at least 12 weeks up to 24 weeks.
Detailed description
- Investigational product(s)： NRICM102 Decoction
- Development Phase: A real-world Prospective study
- Study Design：
- Experimental Group: Standard of care combined NRICM102 for 12weeks
- Blinding：Open
- Randomization: No
- Parallel design : Not applicable
- Treatment Period：12 to 24 weeks by groups
- Study Period: From 01/07/2024 to 31/12/2025
- Dose adjustment： Not applicable
- Study location： Single
- Study Procedures： This study is to assess safety and efficacy of NRICM102 decoction in participants with CLRD. This study will be conducted in 70 participants. The study consists of 3 periods: a 4-week screening period, a treatment period for at least 12 weeks up to 24 weeks. In principle, the two groups are divided into 1:1. The study group period is divided into a continuous treatment group and a discontinued treatment group. The purpose is to evaluate the drug safety of continuous treatment for 24 weeks and the similarities and differences in the physiological assessment of the subjects between the two groups, so as to serve as a reference for the design of a combined treatment program of traditional Chinese and Western medicine for chronic respiratory diseases. Since subjects may terminate early during the taking period, we also designed an evaluation time point, and also conducted an evaluation at the early end of time (EOS).
- Statistical Methods：
- Main study Hypothesis：Not applicable
- Estimated Sample Size：This study will be conducted in 70 participants. 50 subjects can be evaluated in the trial.
- Efficacy assessment group：Intent-to-treat (ITT)
- Interim analysis：No
- Statistical methods： All participants who have been randomized to study intervention and who have received at least one dose of study intervention will be included in the Efficacy Analysis Set. The Safety Analysis Set is defined as all participants who have been randomized to study intervention.
All results will be presented by treatment with descriptive statistics appropriate to the nature of the variables. Demographic and baseline characteristics will be presented as follows; for continuous variables, the number of non-missing observations, mean, standard deviation (SD), standard error (SE) of the mean, 95% confidence interval (CI) of the mean (except safety data), median, first and third quartiles, minimum and maximum, will be presented; for categorical variables: counts (n) and percentages (%) (where specified) will be presented. These summaries will be provided by time point of assessment as appropriate.
Details on the handling of missing data for the safety or efficacy analyses will be provided.
- Safety will be assessed by descriptive analysis of vital signs, ECGs, laboratory assessments and AEs reported.
- Change from baseline in health related QOL questionnaires ACT, ACQ-5, CAT, SGRQ and mMRC, spirometry and walking distance of visit and average over the treatment period will be reported, and subgroup analysis in CLRT will be provided at Weeks 4, 12, 24 and average over the treatment period.
- 6. Handling of Missing Data： The missing data will not be included in the analysis.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A. Combining NRICM102 decoction with standard treatment for 12 weeks | Other | Combination Product: NRICM102Combining NRICM102 decoction with standard treatment for 12 weeks |
| B. Combining NRICM102 decoction with standard treatment for 24 weeks | Other | Combination Product: NRICM102Combining NRICM102 decoction with standard treatment for 24 weeks |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years of age
- Diagnosed of chronic lower respiratory tract disorder(such as : asthma, COPD, emphysema, chronic bronchitis, bronchiectasis, lung fibrosis) by pulmonologist
- Have symptom of chronic cough, cough with sputum after using of a maintenance respiratory medication and stable disease more than 3 months.
- Willing to be evaluated by a Traditional Chinese Physician whether use of NRICM102 is suitable.
- The patient can use NRICM102 therapy after Traditional Chinese Physician evaluate. Able to understand and sign an informed consent ( or have a legal representative who is able to do so)
Key exclusion criteria (7 listed)
- Females who are breastfeeding or pregnant at screening.
- Life threatening (e.g. intensive care admission and/or use of mechanical ventilation) respiratory failure event in the past 3 months.
- Patients with gastrointestinal malabsorption or condition that might affect the absorption of NRICM102 in the opinion of investigator. (exp: Irritable bowel syndrome, acute gastritis, duodenal ulcer..).
- Acute exacerbation or unstable vital signs on screening stage.
- Patient who have malignancy and receiving chemotherapy/ target therapy at 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 |
|---|---|---|
| NRICM102A traditional Chinese medicine formula | Combination product | A. Combining NRICM102 decoction with standard treatment for 12 weeks, B. Combining NRICM102 decoction with standard treatment for 24 weeks |
Primary outcome
To evaluate the safety of combining NRICM102 decoction with standard treatment for 12 to 24 weeks in subjects comorbid with chronic respiratory diseases to treat the chronic respiratory symptoms
Time frame: Up to study completion approximately 24 weeks
The proportion of AE and/or SAE with grading.
6 secondary outcomes
Asthma control test (ACT) for asthma patients among different treatment periods (12 or 24 weeks)
Time frame: Up to study completion approximately 24 weeks
Asthma Control Questionnaire (ACQ)-5 for asthma patients among different treatment periods (12 or 24 weeks)
Time frame: Up to study completion approximately 24 weeks
The COPD Assessment Test (CAT) among different treatment periods (12 or 24 weeks)
Time frame: Up to study completion approximately 24 weeks
St. George's Respiratory Questionnaire (SGRQ) among different treatment periods (12 or 24 weeks)
Time frame: Up to study completion approximately 24 weeks
modified Medical Research Council (mMRC) scale among different treatment periods (12 or 24 weeks)
Time frame: Up to study completion approximately 24 weeks
Body Constitution Questionnaire (BCQ) in traditional Chinese medicine among different treatment periods (12 or 24 weeks)
Time frame: Up to study completion approximately 24 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 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.
Pin-Kuei Fu principal investigator
chairman; Integrated Care Center of Interstitial Lung Disease (ICCILD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NRICM102 in people with Chronic Lower Respiratory Diseases, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 5 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 15 Nov 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 Taiwan. 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
To evaluate the safety of combining NRICM102 decoction with standard treatment for 12 to 24 weeks in subjects comorbid with chronic respiratory diseases to treat the chronic respiratory symptoms (time frame: Up to study completion approximately 24 weeks). 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 15 Nov 2024; AzTrials last refreshed its copy on 8 Nov 2026.