Chronic Obstructive Pulmonary Disease (COPD)Phase 3NCT06643078
A Study to Evaluate the Safety and Efficacy of HL231 Solution for Inhalation in Patients With COPD
A Phase 3 study testing HL231 Solution for Inhalation and Ultibro 110μg/50 μg in people with Chronic Obstructive Pulmonary Disease (COPD), run by Haisco Pharmaceutical Group Co., Ltd. at 2 sites in China.
Trial summary
To evaluate the efficacy and safety of HL231 Solution for Inhalation vs Ultibro in Chinese patients with moderate to very severe COPD Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- HL231 Solution for Inhalation and Ultibro 110μg/50 μg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 487 participants
- Where
- 2 sitesChina
- Study dates
- 11 Dec 2023to 5 Dec 2025
- Phase
- Phase 3
- 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 2023.
- 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.
- Modified Medical Research Council (mMRC) grade of at least 2 at visit 1.
Who cannot join
- 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.
- Patients with a history of serious cardiovascular disease;
- Patients with Type I or uncontrolled Type II diabetes;
- 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;
- Patients who have had hospitalized due to COPD or pneumonia within 8 weeks prior to screening (Visit 1) or screening.
- 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.
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- 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).
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200433
About this study
Official title: 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)
To evaluate the efficacy and safety of HL231 Solution for Inhalation vs Ultibro in Chinese patients with moderate to very severe COPD
- Being tested
- HL231 Solution for Inhalation, Ultibro 110μg/50 μg
- 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 Solution for InhalationDrug
HL231 Solution for Inhalation, 3ml:261 μg/141μg, once per day via PARI BOY nebulizer, consisting of a fixed dose combination of indacaterol 261µg and glycopyrronium 141µg, treatment period; 52-weeks fixed dose.
Ultibro 110μg/50 μgDrug
Ultibro capsule for inhalation once per day via Breezhaler, consisting of a fixed dose combination of indacaterol 110µg and glycopyrronium 50µg, treatment period; 52-weeks fixed dose.
| Study group | Role | What they receive |
|---|---|---|
| HL231 Solution for Inhalation | Experimental | Not described Receives: Drug: HL231 Solution for Inhalation |
| Ultibro | Active comparator | Not described Receives: Drug: Ultibro 110μg/50 μg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment
Measured: 26 weeks
Secondary outcomes (6)
Rate of Moderate to Severe COPD Exacerbations within weeks 26 and 52
Measured: 26, 52 weeks
Change from baseline in Trough Forced Expiratory Volume In One Second (FEV1) at week 6,12,18,34,42,52.
Measured: 6,12,18,34,42,52 weeks
Standardized FEV1 Area Under the Curve (AUC) From zero to 4 Hours at Day 1 and Week 26
Measured: Day 1,week 26
Change from baseline in COPD assessment test (CAT) score at Week 26 and 52.
Measured: 26, 52 weeks
Rescue Medication Use: Summary of the Mean Daily Number of Puffs of Rescue Medication within Week 26 and 52.
Measured: 26, 52 weeks
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: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2024
- Study start11 Dec 2023
- Primary completion12 May 2025
- Study completion5 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by Haisco Pharmaceutical Group Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 487 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Sichuan Haisco Pharmaceutical Group Co., Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06643078
- Sponsor's protocol ID
- HEISCO-231-301
- Status last verified
- Mar 2026
- First submitted
- 29 Sep 2024
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06643078
- Acronym / sponsor ID
- HEISCO-231-301
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 487 participants (actual)
- Lead sponsor
- Haisco Pharmaceutical Group Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Sichuan Haisco Pharmaceutical Group Co., Ltd
- Study start
- 11 Dec 2023 (actual)
- Primary completion
- 12 May 2025 (actual)
- Study completion
- 5 Dec 2025 (actual)
- First posted
- 15 Oct 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the efficacy and safety of HL231 Solution for Inhalation vs Ultibro in Chinese patients with moderate to very severe COPD
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HL231 Solution for Inhalation | Experimental | Drug: HL231 Solution for Inhalation |
| Ultibro | Active comparator | Drug: Ultibro 110μg/50 μg |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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 2023.
- 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.
- Modified Medical Research Council (mMRC) grade of at least 2 at visit 1.
Key exclusion criteria (9 listed)
- 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.
- Patients with a history of serious cardiovascular disease;
- Patients with Type I or uncontrolled Type II diabetes;
- 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;
- Patients who have had hospitalized due to COPD or pneumonia within 8 weeks prior to screening (Visit 1) or screening.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HL231 Solution for InhalationHL231 Solution for Inhalation, 3ml:261 μg/141μg, once per day via PARI BOY nebulizer, consisting of a fixed dose combination of indacaterol 261µg and glycopyrronium 141µg, treatment period; 52-weeks fixed dose. | Drug | HL231 Solution for Inhalation |
| Ultibro 110μg/50 μgUltibro capsule for inhalation once per day via Breezhaler, consisting of a fixed dose combination of indacaterol 110µg and glycopyrronium 50µg, treatment period; 52-weeks fixed dose. | Drug | Ultibro |
Primary outcome
Change from baseline in Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment
Time frame: 26 weeks
6 secondary outcomes
Rate of Moderate to Severe COPD Exacerbations within weeks 26 and 52
Time frame: 26, 52 weeks
Change from baseline in Trough Forced Expiratory Volume In One Second (FEV1) at week 6,12,18,34,42,52.
Time frame: 6,12,18,34,42,52 weeks
Standardized FEV1 Area Under the Curve (AUC) From zero to 4 Hours at Day 1 and Week 26
Time frame: Day 1,week 26
Change from baseline in COPD assessment test (CAT) score at Week 26 and 52.
Time frame: 26, 52 weeks
Rescue Medication Use: Summary of the Mean Daily Number of Puffs of Rescue Medication within Week 26 and 52.
Time frame: 26, 52 weeks
Adverse event rate
Time frame: 52 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing HL231 Solution for Inhalation and Ultibro 110μg/50 μg in people with Chronic Obstructive Pulmonary Disease (COPD), run by Haisco Pharmaceutical Group Co., Ltd. at 2 sites 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 4 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 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Change from baseline in Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment (time frame: 26 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2026.