Evaluating HL231 Solution for Inhalation in COPD Patients
A Multicenter, Randomized, Single-blind, Active-controlled, Parallel-designed Phase III Clinical Study to Evaluate the Efficacy and Safety of HL231 Solution for Inhalation in Patients with Chronic Obstructive Pulmonary Disease (COPD)
This study is testing a new inhalation treatment called HL231 to see if it helps people with moderate to very severe COPD feel better compared to a current medication called Ultibro.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 474 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Haisco Pharmaceutical Group Co., Ltd. Industry-sponsored |
| Locations | 2 sites (Shanghai, Shanghai and 1 other locations) |
| Trial ID | NCT06643078 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the safety and efficacy of HL231 Solution for Inhalation compared to Ultibro in Chinese patients diagnosed with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). Participants must meet specific criteria, including age and spirometry results, to ensure they have a clinical diagnosis of COPD. The study will involve administering the treatment and monitoring patient outcomes to determine the effectiveness of HL231. The trial is designed to provide insights into a new therapeutic option for managing COPD symptoms.
Who should consider this trial
Good fit: Ideal candidates are Chinese males and females aged 40 and older with moderate to severe COPD confirmed by spirometry.
Not a fit: Patients with other significant respiratory diseases or serious cardiovascular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new effective option for managing COPD symptoms in patients.
How similar studies have performed: Other studies have shown promise in evaluating new inhalation therapies for COPD, suggesting potential for success with this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Males and females of Chinese ethnicity, at least 40 years of age. 2. Patients with with a clinical diagnosis of moderate to severe COPD confirmed by spirometry according to according to GOLD criteria 2023. 3. Patients with a post-bronchodilator Forced Expiratory Volume in one second (FEV1) \< 80% of the predicted normal value, and post-bronchodilator FEV1/FVC (Forced Vital Capacity) \< 0.70 at visit 1. 4. Modified Medical Research Council (mMRC) grade of at least 2 at visit 1. Exclusion Criteria: 1. Patients with any of the following diseases:α-1 antitrypsin deficiency, asthma, active pulmonary tuberculosis, lung cancer, pulmonary edema, cystic fibrosis, obliterated bronchiolitis, sarcoidosis, or other diseases that the investigator considers to be at risk of safety/efficacy for the patient, e.g lung fibrosis, pulmonary hypertension, interstitial lung disorder, active bronchiectasis. 2. Patients with a history of serious cardiovascular disease; 3. Patients with Type I or uncontrolled Type II diabetes; 4. 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; 5. Patients who have had hospitalized due to COPD or pneumonia within 8 weeks prior to screening (Visit 1) or screening. 6. Patients who have had an acute (viral or bacterial) upper or lower respiratory tract infection, sinusitis, pharyngitis or urinary tract infections within 4 weeks prior to screening (Visit 1) or screening. 7. Patients who have had a COPD exacerbation that required treatment with systemic steroids, hospitalization or emergency treatment in the 8 weeks prior to screening (Visit 1). 8. 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. Other protocol-defined inclusion/exclusion criteria may apply.
Where this trial is running
Shanghai, Shanghai and 1 other locations
- Shanghai Pulmonary Hospital — Shanghai, Shanghai, China (Recruiting)
- West China Hospital of Sichuan University — Chengdu, Sichuan, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.