Evaluation of the Safety and Clinical Efficacy of NRICM102 in Patients With Chronic Lower Respiratory Tract Diseases

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Chronic Lower Respiratory Diseases
• Intervention / Treatment: Combination product: NRICM102

Detailed Description

• Investigational product(s)： NRICM102 Decoction
• Development Phase: A real-world Prospective study

• Study Design：

  1. Experimental Group: Standard of care combined NRICM102 for 12weeks
  2. Blinding：Open
  3. Randomization: No
  4. Parallel design : Not applicable
  5. Treatment Period：12 to 24 weeks by groups
  6. Study Period: From 01/07/2024 to 31/12/2025
  7. Dose adjustment： Not applicable
  8. 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：

  1. Main study Hypothesis：Not applicable
  2. Estimated Sample Size：This study will be conducted in 70 participants. 50 subjects can be evaluated in the trial.
  3. Efficacy assessment group：Intent-to-treat (ITT)
  4. Interim analysis：No
  5. 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.

1. Safety will be assessed by descriptive analysis of vital signs, ECGs, laboratory assessments and AEs reported.

2. 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 Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • No.1650, Taiwan Boulevard Sect. 4
    • Taichung, No.1650, Taiwan Boulevard Sect. 4, Taiwan, 40705
      • Taichung Veterans General Hospita

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: A. Combining NRICM102 decoction with standard treatment for 12 weeks; Combining NRICM102 decoction with standard treatment for 12 weeks	Combination product: NRICM102; A traditional Chinese medicine formula
Other: B. Combining NRICM102 decoction with standard treatment for 24 weeks; Combining NRICM102 decoction with standard treatment for 24 weeks	Combination product: NRICM102; A traditional Chinese medicine formula

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Up to study completion approximately 24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma control test (ACT) for asthma patients among different treatment periods (12 or 24 weeks)		Up to study completion approximately 24 weeks
Asthma Control Questionnaire (ACQ)-5 for asthma patients among different treatment periods (12 or 24 weeks)		Up to study completion approximately 24 weeks
The COPD Assessment Test (CAT) among different treatment periods (12 or 24 weeks)		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)	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	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	Up to study completion approximately 24 weeks

Collaborators and Investigators

• Sponsor: Taichung Veterans General Hospital
• Investigators: Principal Investigator: Pin-Kuei Fu, chairman; Integrated Care Center of Interstitial Lung Disease (ICCILD)

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2024
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: October 15, 2024
• First Submitted That Met QC Criteria: November 14, 2024
• First Posted (Actual): November 15, 2024

Study Record Updates

• Last Update Posted (Actual): November 15, 2024
• Last Update Submitted That Met QC Criteria: November 14, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Inflammation; safety; Biomarkers; Chronic lower respiratory diseases; NRICM102
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders
• Other Study ID Numbers: CF24327B

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