## Protocol Section
### Identification Module
**NCT ID:** NCT06434792

**Brief Title:** Study to Evaluate Efficacy and Safety of Bronpass Tab. in Patients With Chronic Obstructive Pulmonary Disease

**Official Title:** A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Dose-response Phase 2 Clinical Trial to Compare the Efficacy and Safety of Bronpass Tab. Versus Placebo in Patients With Stable COPD

#### Organization Study ID Info
**ID:** HL_HL301_204
#### Organization
**Class:** INDUSTRY
**Full Name:** Hanlim Pharm. Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2025-03

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-06-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2023-09-18
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Hanlim Pharm. Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief Summary:** This clinical trial is a multicenter, randomized, double-blind, placebo-controlled, parallel-group dose-response phase 2 clinical trial study to evaluate the efficacy and safety of Bronpass Tab. in 96 patients with chronic obstructive pulmonary disease.

**Detailed Description:** This study is to prove that Bronpass Tab. is superior in clinical efficacy and safety in improving COPD symptoms compared to placebo for 12 weeks in patients suffering from chronic obstructive pulmonary disease.

### Conditions Module

**Conditions:**

- Chronic Obstructive Pulmonary Disease

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- INVESTIGATOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 96

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Twice daily for 12 weeks

**Intervention Names:**

- Drug: Bronpass Tab.

**Label:** Bronpass Tab.

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Twice daily for 12 weeks

**Intervention Names:**

- Other: Placebo

**Label:** Placebo

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Bronpass Tab.

**Description:** Twice daily for 12 weeks

**Name:** Bronpass Tab.

**Other Names:**

- HL301

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- Placebo

**Description:** Twice daily for 12 weeks

**Name:** Placebo

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Measure:** Change from baseline in CAT(COPD Assessment Test) total score at Visit 5

**Time Frame:** Time frame: 3 months(Visit 5)

#### Secondary Outcomes

**Measure:** Change from baseline in CAT total score at Visit 3 and Visit 4

**Time Frame:** Time frame: 1 month(Visit 3), 2 months(Visit 4)

**Measure:** Change from baseline in CAT cough score at Visit 3, Visit 4, and Visit 5

**Time Frame:** Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)

**Measure:** Change from baseline in CAT sputum score at Visit 3, Visit 4, and Visit 5

**Time Frame:** Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)

**Measure:** Incidence of moderate and severe COPD exacerbations from baseline to Visit 5

**Time Frame:** Time frame: 3 months(Visit 5)

**Measure:** Change frome baseline in PFT(Pulmonary Function Test) such as FEV1(Forced Expiratory Volume in one second), FVC(Forced Vital Capacity), FEV1/FVC at Visit 5

**Time Frame:** Time frame: 3 months(Visit 5)

**Measure:** Change from baseline in SGRQ-C(St. George's Respiratory Questionnaire for COPD patients) Score at Visit 3, Visit 4, and Visit 5

**Time Frame:** Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)

**Measure:** Change from baseline in COAT(Cough Assessment Test) Score at Visit 3, Visit 4, and Visit 5

**Time Frame:** Time frame: 1 month(Visit 3), 2 months(Visit 4), 3 months(Visit 5)

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

1. 40 years ≤ age
2. Patients who are diagnosed as COPD (based on the definition in the Korean Society of Tuberculosis and Respiratory Diseases COPD Guidelines)
3. Patients who meet all of the following criteria at the screening test

   * FEV1/FVC \< 0.70 after bronchodilator administration
   * 30% ≤ FEV1 \< 80% predicted after bronchodilator administration
   * Cough or sputum-related score on the CAT ≥ 3
4. Current or former smokers with a smoking history of 10 pack-years or more at screening.
5. Patients who have listened to a detailed explanation of this clinical trial, fully understand it, and voluntarily provide written consent to participate.

Exclusion Criteria:

1. Patients with a current medical history of asthma (However, patients previously diagnosed as asthma who have recovered and currently have a diagnosis of COPD are eligible for participation.)
2. Patients with a medical history of respiratory diseases other than COPD
3. Patients who have undergone lung volume reduction surgery.
4. Patients with a history of lung transplantation.
5. Patients with a history of respiratory infections within 4 weeks prior to screening
6. Patients with a history of moderate or severe acute exacerbation within 4 weeks prior to screening.
7. Pregnant or lactating women.
8. Patients who are considered ineligible for this clinical trial due to other reasons as judged by the investigator.

**Minimum Age:** 40 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** 20130643@kuh.ac.kr

**Name:** Kwang Ha Yoo, MD, PhD

**Phone:** 82-2-2030-5114

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Seoul

**Contacts:**

***Contact 1:***

- **Email:** 20130643@kuh.ac.kr

- **Name:** Kwang Ha Yoo, MD, PhD

- **Phone:** 82-2-2030-5114

- **Role:** CONTACT

**Country:** Korea, Republic of

**Facility:** Konkuk University School of Medicine

**Status:** RECRUITING

**Zip:** 05030

#### Overall Officials

**Official 1:**

**Affiliation:** Konkuk University

**Name:** Kwang Ha Yoo, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012140

- Term: Respiratory Tract Diseases

- ID: D000002908

- Term: Chronic Disease

- ID: D000020969

- Term: Disease Attributes

- ID: D000010335

- Term: Pathologic Processes

### Condition Browse Module - Browse Branches

- Abbrev: BC08

- Name: Respiratory Tract (Lung and Bronchial) Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M11168

- Name: Lung Diseases

- Relevance: HIGH

- As Found: Pulmonary Disease

- ID: M11170

- Name: Lung Diseases, Obstructive

- Relevance: HIGH

- As Found: Obstructive Pulmonary Disease

- ID: M23449

- Name: Pulmonary Disease, Chronic Obstructive

- Relevance: HIGH

- As Found: Chronic Obstructive Pulmonary Disease

- ID: M14977

- Name: Respiratory Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: M22700

- Name: Disease Attributes

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000008171

- Term: Lung Diseases

- ID: D000008173

- Term: Lung Diseases, Obstructive

- ID: D000029424

- Term: Pulmonary Disease, Chronic Obstructive

### Misc Info Module

- Version Holder: 2024-05-31
