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Chronic Obstructive Pulmonary Disease (COPD)Phase 2NCT06619210

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

A Phase 2 study testing HL231 Dose 1/2/3/4 in people with Chronic Obstructive Pulmonary Disease (COPD), run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 40 years and older
What is being tested?
HL231 Dose 1/2/3/4
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
102 participants
Where
1 siteChina
Study dates
12 Jan 2022to 29 May 2023
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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.
  • Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

1 site in 1 country.

China1 site

  • West China Hospital of Sichuan University

    Chengdu, Sichuan, 610041

Other trials in China

About this study

Official title: A Multicenter, Randomized, Placebo and Active Controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of HL231 Solution for Inhalation in Patients with Chronic Obstructive Pulmonary Disease (COPD)

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

Read the detailed description

This study is a randomized, single-dose, multi-center, two-part, crossover, dose-ranging study of HL231 in the treatment of subjects with COPD. This study is divided into 2 parts.

Part A is a 5 treatment period single dose study. Each treatment period will be separated by a washout period of at least 14 days. The primary comparison for bronchodilation was between HL231 doses vs Ultibro or placebo in COPD patients.

Part B is a 3 treatment period single dose study. Each treatment period will be separated by a washout period of at least 14 days. The primary comparison for pharmacokinetic profile was between HL231 vs Ultibro in COPD patients.

Being tested
HL231 Dose 1/2/3/4
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HL231 Dose 1/2/3/4Drug

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

Study groups in NCT06619210
Study groupRoleWhat they receive
HL231 Dose 1（Part A）Experimentalsingle dose, oral inhalation by PARI BOY nebulizer
Receives: Drug: HL231 Dose 1/2/3/4
HL231 Dose 2（Part A）Experimentalsingle dose, oral inhalation by PARI BOY nebulizer
Receives: Drug: HL231 Dose 1/2/3/4
HL231 Dose 3（Part A）Experimentalsingle dose, oral inhalation by PARI BOY nebulizer
Receives: Drug: HL231 Dose 1/2/3/4
Ultibro （Part A）Active comparatorUltibro capsule for inhalation, consisting of a fixed dose combination of indacaterol 110µg and glycopyrronium 50µg, single dose, oral inhalation by Breezhaler
Receives: Drug: HL231 Dose 1/2/3/4
Placebo Solution for Inhalation (Part A)Placebo comparatorPlacebo Solution for Inhalation, single dose, oral inhalation by PARI BOY nebulizer
Receives: Drug: HL231 Dose 1/2/3/4
HL231 Dose 2（Part B）Experimentalsingle dose, oral inhalation by PARI BOY nebulizer
Receives: Drug: HL231 Dose 1/2/3/4
HL231 Dose 4（Part B）Experimentalsingle dose, oral inhalation by PARI BOY nebulizer
Receives: Drug: HL231 Dose 1/2/3/4
Active Comparator （Part B）Active comparatorUltibro capsule for inhalation, consisting of a fixed dose combination of indacaterol 110µg and glycopyrronium 50µg, single dose, oral inhalation by Breezhaler
Receives: Drug: HL231 Dose 1/2/3/4

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to 12 hours after investigational product administration

  2. Part B：Pharmacokinetic variables: AUC0-t

    Measured: Up to 144 hours after investigational product administration

  3. Part B：Pharmacokinetic variables: AUC0-∞

    Measured: Up to 144 hours after investigational product administration

  4. Part B：Pharmacokinetic variables: Cmax

    Measured: Up to 144 hours after investigational product administration

Secondary outcomes (6)

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

    Measured: Up to 24 hours after investigational product administration

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

    Measured: Up to 4 hours after investigational product administration

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

    Measured: Up to 12 hours after investigational product administration

  4. Part B: Pharmacokinetic variables: Tmax

    Measured: Up to 144 hours after investigational product administration

  5. Part B: Pharmacokinetic variables: t1/2

    Measured: Up to 144 hours after investigational product administration

  6. Part A & Part B：Adverse event rate

    Adverse events are summarized according to the system organ classification and standard name, and the system organ classification and standard name are arranged in descending order of the frequency of the tested preparation group

    Measured: From the time of informed consent up to 14 (±2) days after the last dose of investigational product.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Oct 2024
  2. Study start12 Jan 2022
  3. Primary completion29 May 2023
  4. Study completion29 May 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
102 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06619210
Sponsor's protocol ID
HEISCO-231-201
Status last verified
Oct 2024
First submitted
12 Sep 2024
Last updated
16 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 41229760

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing HL231 Dose 1/2/3/4 in people with Chronic Obstructive Pulmonary Disease (COPD), run by Haisco Pharmaceutical Group Co., Ltd. at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part A：Change from baseline in Forced Expiratory Volume in 1 Second Area Under the Curve (FEV1 AUC) 0-12 Hours (time frame: Up to 12 hours after investigational product administration). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06619210, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2024.

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