A Trial to Evaluate the Safety and Efficacy of HL231 Solution for Inhalation in Patients with COPD

NCT06619210 | Completed Phase 2

• 1 other identifier: HEISCO-231-201
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the efficacy and safety of HL231 Solution for Inhalation vs Ultibro in Chinese patients with moderate to severe COPD.

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Outcome Measures

Primary Outcomes (4)

• Part A：Change from baseline in Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours

  Up to 12 hours after investigational product administration

• Part B：Pharmacokinetic variables: AUC0-t

  Up to 144 hours after investigational product administration

• Part B：Pharmacokinetic variables: AUC0-∞

  Up to 144 hours after investigational product administration

• Part B：Pharmacokinetic variables: Cmax

  Up to 144 hours after investigational product administration

Secondary Outcomes (6)

• Part A & Part B：Change from baseline in Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-24 Hours

  Up to 24 hours after investigational product administration

• Part A & Part B：Change from baseline in Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-4 Hours

  Up to 4 hours after investigational product administration

• Part B：Change from baseline in Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours

  Up to 12 hours after investigational product administration

• Part B: Pharmacokinetic variables: Tmax

  Up to 144 hours after investigational product administration

• Part B: Pharmacokinetic variables: t1/2

  Up to 144 hours after investigational product administration

Study Arms (8)

HL231 Dose 1（Part A）

EXPERIMENTAL

single dose, oral inhalation by PARI BOY nebulizer

Drug: HL231 Dose 1/2/3/4

HL231 Dose 2（Part A）

EXPERIMENTAL

single dose, oral inhalation by PARI BOY nebulizer

Drug: HL231 Dose 1/2/3/4

HL231 Dose 3（Part A）

EXPERIMENTAL

single dose, oral inhalation by PARI BOY nebulizer

Drug: HL231 Dose 1/2/3/4

Ultibro （Part A）

ACTIVE COMPARATOR

Ultibro capsule for inhalation, consisting of a fixed dose combination of indacaterol 110µg and glycopyrronium 50µg, single dose, oral inhalation by Breezhaler

Drug: HL231 Dose 1/2/3/4

Placebo Solution for Inhalation (Part A)

PLACEBO COMPARATOR

Placebo Solution for Inhalation, single dose, oral inhalation by PARI BOY nebulizer

Drug: HL231 Dose 1/2/3/4

HL231 Dose 2（Part B）

EXPERIMENTAL

single dose, oral inhalation by PARI BOY nebulizer

Drug: HL231 Dose 1/2/3/4

HL231 Dose 4（Part B）

EXPERIMENTAL

single dose, oral inhalation by PARI BOY nebulizer

Drug: HL231 Dose 1/2/3/4

Active Comparator （Part B）

ACTIVE COMPARATOR

Ultibro capsule for inhalation, consisting of a fixed dose combination of indacaterol 110µg and glycopyrronium 50µg, single dose, oral inhalation by Breezhaler

Drug: HL231 Dose 1/2/3/4

Interventions

HL231 Dose 1/2/3/4 DRUG

HL231 Solution for Inhalation, dose 1/2/3 (Part A) , dose 2/4（Part B） single dose, oral inhalation by PARI BOY nebulizer

Active Comparator （Part B）; HL231 Dose 1（Part A）; HL231 Dose 2（Part A）; HL231 Dose 2（Part B）; HL231 Dose 3（Part A）; HL231 Dose 4（Part B）; Placebo Solution for Inhalation (Part A); Ultibro （Part A）

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females of Chinese ethnicity, at least 40 years of age;
• Patients with with a clinical diagnosis of moderate to severe COPD confirmed by spirometry according to according to GOLD criteria；
• Current or ex-smokers with a\>10 year pack history；
• Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) \< 80% and ≥ 30% of the predicted normal value , and post-bronchodilator FEV1/FVC (Forced Vital Capacity) \< 0.70 at visit 1；
• Patients have airway reversibility based a ≥12% increase in FEV1 following ipratropium and salbutamol treatment；
• Patients on no maintenance/background therapy or could withhold prohibited COPD medications in protocol during the screening and treatment period (except study-supplied salbutamol as an rescue medication);
• Modified Medical Research Council (mMRC) grade of at least 2 at visit 1.

You may not qualify if:

• Patients with any of the following significant diseases: α-1 antitrypsin deficiency, cystic fibrosis, significant asthma, active bronchiectasis, obliterated bronchiolitis, active pulmonary tuberculosis, sarcoidosis, lung fibrosis, pulmonary hypertension, pulmonary edema, interstitial lung disorder, lung cancer or other active pulmonary disease；
• Evidence or history of other clinically significant cardiovascular disease or abnormality (such as, but not limited to, unstable ischemic heart disease, congestive heart failure, uncontrolled hypertension, uncontrolled coronary artery disease, myocardial infarction, arrhythmia, long QT syndrome, paroxysmal atrial fibrillation), renal, neurological, endocrine, immunological, psychiatric, gastrointestinal, hepatic, or hematological disease or abnormality which, in the opinion of the investigator, would put the patient at risk through study participation, or would affect the study analyses if the disease exacerbates during the study;
• Patients with paradoxical bronchospasm, narrow-angle glaucoma, symptomatic benign prostatic hyperplasia(benign prostatic hyperplasia patients who were stable on treatment could have been considered), bladder-neck obstruction, severe renal impairment, or urinary retention, or any other medical history, which, in the opinion of the investigator, would contraindicate the use of an anticholinergic agent;
• Hospitalization for COPD or pneumonia within 12 weeks prior to screening (Visit 1) or screening;
• Patients who have had a COPD exacerbation that required treatment with antibiotics, systemic steroids , hospitalization or emergency treatment in the 12 weeks prior to screening (Visit 1);
• Patients who have had an acute (viral or bacterial) upper or lower respiratory tract infection, sinusitis, pharyngitis or urinary tract infections within 6 weeks prior to screening (Visit 1) or screening;
• Patients with conditions contraindicated for treatment with or having a history of allergy or hypersensitivity to any of the following inhaled drugs, drugs of a similar class or any component thereof: Anticholinergic/muscarinic receptor antagonist, Long- or short-acting β2-agonists, Sympathomimetic amines, Lactose/milk proteins, or any of the other excipients of the delivery system;
• History of frequent COPD exacerbations of moderate to severe severity averaging 2 or more per year, over the last 3 years.

Sponsors & Collaborators

• Haisco Pharmaceutical Group Co., Ltd.: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, 610041, China

Location

Related Publications (1)

• Hu Q, Zhao L, Yang G, Wen F, Xie L, Xiao Z, Chen F, He Q, Bian T, Xiong H, Li F, Yue Y, Li Y, Luo L, Luo Z. Efficacy, pharmacokinetics, and safety of nebulized HL231 inhalation solution in patients with chronic obstructive pulmonary disease: a randomized trial. J Thorac Dis. 2025 Oct 31;17(10):7459-7472. doi: 10.21037/jtd-2025-1130. Epub 2025 Oct 9.

  PMID: 41229760 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhu Luo, M.D.

  West China Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2024
• First Posted: October 1, 2024
• Study Start: January 12, 2022
• Primary Completion: May 29, 2023
• Study Completion: May 29, 2023
• Last Updated: October 16, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)