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

NCT06690203 | Enrolling By Invitation

• 1 other identifier: CF24327B
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Lower Respiratory Diseases

Keywords

Chronic lower respiratory diseases; NRICM102; Inflammation; safety; Biomarkers

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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)

  Up to study completion approximately 24 weeks

• modified Medical Research Council (mMRC) scale among different treatment periods (12 or 24 weeks)

  Up to study completion approximately 24 weeks

Study Arms (2)

A. Combining NRICM102 decoction with standard treatment for 12 weeks

OTHER

Combining NRICM102 decoction with standard treatment for 12 weeks

Combination Product: NRICM102

B. Combining NRICM102 decoction with standard treatment for 24 weeks

OTHER

Combining NRICM102 decoction with standard treatment for 24 weeks

Combination Product: NRICM102

Interventions

NRICM102 COMBINATION_PRODUCT

A traditional Chinese medicine formula

A. Combining NRICM102 decoction with standard treatment for 12 weeks; B. Combining NRICM102 decoction with standard treatment for 24 weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans General Hospita

Taichung, No.1650, Taiwan Boulevard Sect. 4, 40705, Taiwan

Location

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Pin-Kuei Fu

  chairman; Integrated Care Center of Interstitial Lung Disease (ICCILD)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open Label
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director; Integrated Care Center of Interstitial Lung Disease (ICCILD)

Study Record Dates

• First Submitted: October 15, 2024
• First Posted: November 15, 2024
• Study Start: September 30, 2024
• Primary Completion: October 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 15, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)