COPD PatientsPhase 4NCT03851991
The Efficacy and Safety of Arbidol in Reducing the Frequency of AECOPD.
A Phase 4 study testing Arbidol in people with COPD Patients, run by Shengjing Hospital at 1 site in China.
Trial summary
Chronic Obstructive Pulmonary Disease (COPD) is currently the fourth leading cause of death in the world. Acute exacerbations of COPD (AECOPD) are the most important events in the course of the disease because they negatively impact health status, life quality, disease progression, patients survival and economic and… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- COPD Patients
- What is being tested?
- Arbidol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 351 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2019to 31 Oct 2024
- Phase
- Phase 4
- 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
- Patients from Outpatient clinic.
- Informed consent and assent must be obtained before any study assessment is performed.
- Aged ≥40 years.
- Continuous respiratory symptoms, such as chronic cough, sputum or shortness of breath etc.
- Exposure to risk factors: Host factors, Tobacco, Occupation, Indoor/outdoor pollution
- FEV1/FVC less than 0.70 after withholding bronchodilator.
- 2 or more acute exacerbations of COPD within the 12 months prior to visit 0. Or more than 1 hospitalizations due to AECOPD within the 12 months prior to visit 0.
- Good compliance.
Who cannot join
- Patients with any chronic diseases except COPD which in the opinion of the investigator may interfere with study evaluation or optimal participation in the study.
- Patients with a history of chronic lung disease other than COPD, including (but not limited to) active tuberculosis, lung cancer, clinically significant bronchiectasis, primary pulmonary hypertension, sarcoidosis, interstitial lung disease, asthma (other than asthma COPD overlap), severe cor pulmonale.
- Patients with acute coronary syndrome(ACS) or acute left heart failure within the 6 months prior to visit 0. Patients accepted Coronary interventional therapy or coronary artery bypass grafting due to ACS within the 3 months prior to visit 0.
- Patients with uncontrolled hypertension.
- Patients who started oral >10mg prednisolone or Equivalent systemic corticosteroids within 4 weeks prior to Visit 1. Or patients who received antibiotics within 4 weeks prior to Visit 1. Or patients who received standard treatment for COPD within 4 weeks prior to Visit 1. Or use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.
- Patients who received influenza vaccine or other viral vaccine within the 12 months prior to visit 0.
Show all 11Show fewer
- The end of AECOPD therapy was within the 4 weeks prior to visit 0. Or Occurrence of AECOPD within the 6 weeks prior to visit 0.
- History of arbidol sensitivity.
- No person directly associated with the administration of the study is allowed to participate as a study subject.
- Use of other investigational intervention within within 30 days.
- Patients with obviously abnormal liver function, AST or ALT>2 times the upper limit of normal value or total bilirubin>1.3 times the upper limit of normal value.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A 52-week Multicenter, Randomized, Double-blind, Placebo-controlled, Prospective Study to Evaluate the Efficacy and Safety of Arbidol in Reducing the Frequency of AECOPD.
Chronic Obstructive Pulmonary Disease (COPD) is currently the fourth leading cause of death in the world. Acute exacerbations of COPD (AECOPD) are the most important events in the course of the disease because they negatively impact health status, life quality, disease progression, patients survival and economic and social burden. Reducing frequency of AECOPD is the key goal of management for COPD. Since respiratory viral infections are the mainly trigger of AECOPD, anti-viral therapy would be the affective method to prevent the exacerbation or reduce the attack severity. However, there are no positive study results of treating or preventing AECOPD used by current anti-viral drugs approved by FDA so far.
Arbidol is a non-nucleoside antiviral drug. It inhibits viral DNA and RNA synthesis by inhibiting fusion of viral lipid vesicle membrane with host cell membranes. Arbidol has broad-spectrum antiviral activity. In addition to inhibition of influenza virus, it against a variety of viruses including respiratory syncytial disease (RSV), parainfluenza virus, human rhinovirus, coxsackie virus (CV), adenovirus (ADV) and so on. In recent years, some fundamental and clinical researches have shown that arbidol has a significant role in prevention and treatment of influenza virus and other acute respiratory viral infections. Therefore, the investigators speculate that Arbidol will effectively control COPD combined with upper respiratory virus infection, thereby reducing acute exacerbations of COPD.
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, 52-week study. The purpose of this study is to evaluate the efficacy and safety of arbidol in improving the frequency and extent of moderate or severe acute exacerbations in patients with COPD. Eligible subjects will be randomly assigned to treatment group or placebo group at a 2:1 ratio. Subjects of treatment group receive an on-demand arbidol 200 mg three times per day while placebo group receives matched placebo. When the subject has a new respiratory infection, original respiratory symptoms worsen, or fever (the lower body temperature is greater than 37.3℃), oral medication is given immediately. The subjects are required to receive the first dose of drug within 8 hours after the symptoms of upper respiratory tract infection.
- Conditions
- COPD Patients
- Being tested
- Arbidol, Placebos
- Keywords
- AECOPD, Arbidol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArbidolDrug
oral
PlacebosDrug
controle
| Study group | Role | What they receive |
|---|---|---|
| arbidol | Active comparator | 200mg, three times per day, for 2-5 Days. Receives: Drug: Arbidol |
| control | Placebo comparator | two capsules, three times per day, for 2-5 Days. Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of moderate or severe acute exacerbation in patients with chronic obstructive pulmonary disease
Frequency of moderate or severe acute exacerbation in patients with chronic obstructive pulmonary disease
Measured: 52 weeks
Secondary outcomes (8)
The frequency of Acute exacerbation of patients leads to hospitalization
The frequency of Acute exacerbation of patients leads to hospitalization
Measured: 52 weeks
The intervals to the next acute exacerbation after the first use of the study drug
The intervals to the next acute exacerbation after the first use of the study drug
Measured: 52 weeks
To assess the change of FEV1 from baseline
To assess the change of FEV1 from baseline
Measured: 52 weeks
Mean duration of moderate or severe acute exacerbation in chronic obstructive pulmonary disease
Mean duration of moderate or severe acute exacerbation in chronic obstructive
Measured: 52 weeks
Throat swab and virus separation experiment to detect the composition of respiratory viruses in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) requiring hospitalization
Throat swab and virus separation experiment to detect the composition of respiratory viruses in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) requiring hospitalization
Measured: 52 weeks
Number of unscheduled visits to a clinic for COPD exacerbation
Number of unscheduled visits to a clinic for COPD exacerbation
Measured: 52 weeks
Number of emergency room visits for AECOPD
Number of emergency room visits for AECOPD
Measured: 52 weeks
Number of hospitalizations due to AECOPD
Number of hospitalizations due to AECOPD
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 posted22 Feb 2019
- Study start30 Aug 2019
- Primary completion31 Oct 2023
- Study completion31 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for COPD PatientsStudies of the same condition, open and under way.
- More trials run by Shengjing HospitalThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 351 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shengjing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, LI ZHAO, Shengjing Hospital
- Investigators
- Li Zhao, Doctor, Principal investigator, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03851991
- Sponsor's protocol ID
- HX002
- Status last verified
- Jul 2025
- First submitted
- 21 Feb 2019
- Last updated
- 20 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ko FW, Chan KP, Hui DS, Goddard JR, Shaw JG, Reid DW, Yang IA. Acute exacerbation of COPD. Respirology. 2016 Oct;21(7):1152-65. doi: 10.1111/resp.12780. Epub 2016 Mar 30.
PubMed 27028990Zwaans WA, Mallia P, van Winden ME, Rohde GG. The relevance of respiratory viral infections in the exacerbations of chronic obstructive pulmonary disease-a systematic review. J Clin Virol. 2014 Oct;61(2):181-8. doi: 10.1016/j.jcv.2014.06.025. Epub 2014 Jul 4.
PubMed 25066886Brooks MJ, Burtseva EI, Ellery PJ, Marsh GA, Lew AM, Slepushkin AN, Crowe SM, Tannock GA. Antiviral activity of arbidol, a broad-spectrum drug for use against respiratory viruses, varies according to test conditions. J Med Virol. 2012 Jan;84(1):170-81. doi: 10.1002/jmv.22234. Epub 2011 Oct 25.
PubMed 22028179
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 52-week Multicenter, Randomized, Double-blind, Placebo-controlled, Prospective Study to Evaluate the Efficacy and Safety of Arbidol in Reducing the Frequency of AECOPD.
- ClinicalTrials.gov ID
- NCT03851991
- Acronym / sponsor ID
- HX002
- Conditions
- COPD Patients
- Keywords
- AECOPD, Arbidol
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 351 participants (actual)
- Lead sponsor
- Shengjing HospitalUniversity, hospital or other
- Study start
- 30 Aug 2019 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 22 Feb 2019 (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.
Chronic Obstructive Pulmonary Disease (COPD) is currently the fourth leading cause of death in the world. Acute exacerbations of COPD (AECOPD) are the most important events in the course of the disease because they negatively impact health status, life quality, disease progression, patients survival and economic and social burden. Reducing frequency of AECOPD is the key goal of management for COPD. Since respiratory viral infections are the mainly trigger of AECOPD, anti-viral therapy would be the affective method to prevent the exacerbation or reduce the attack severity. However, there are no positive study results of treating or preventing AECOPD used by current anti-viral drugs approved by FDA so far.
Arbidol is a non-nucleoside antiviral drug. It inhibits viral DNA and RNA synthesis by inhibiting fusion of viral lipid vesicle membrane with host cell membranes. Arbidol has broad-spectrum antiviral activity. In addition to inhibition of influenza virus, it against a variety of viruses including respiratory syncytial disease (RSV), parainfluenza virus, human rhinovirus, coxsackie virus (CV), adenovirus (ADV) and so on. In recent years, some fundamental and clinical researches have shown that arbidol has a significant role in prevention and treatment of influenza virus and other acute respiratory viral infections. Therefore, the investigators speculate that Arbidol will effectively control COPD combined with upper respiratory virus infection, thereby reducing acute exacerbations of COPD.
This is a prospective, multicenter, randomized, double-blind, placebo-controlled, 52-week study. The purpose of this study is to evaluate the efficacy and safety of arbidol in improving the frequency and extent of moderate or severe acute exacerbations in patients with COPD. Eligible subjects will be randomly assigned to treatment group or placebo group at a 2:1 ratio. Subjects of treatment group receive an on-demand arbidol 200 mg three times per day while placebo group receives matched placebo. When the subject has a new respiratory infection, original respiratory symptoms worsen, or fever (the lower body temperature is greater than 37.3℃), oral medication is given immediately. The subjects are required to receive the first dose of drug within 8 hours after the symptoms of upper respiratory tract infection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| arbidol | Active comparator | Drug: Arbidol200mg, three times per day, for 2-5 Days. |
| control | Placebo comparator | Drug: Placebostwo capsules, three times per day, for 2-5 Days. |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients from Outpatient clinic.
- Informed consent and assent must be obtained before any study assessment is performed.
- Aged ≥40 years.
- Continuous respiratory symptoms, such as chronic cough, sputum or shortness of breath etc.
- Exposure to risk factors: Host factors, Tobacco, Occupation, Indoor/outdoor pollution
Key exclusion criteria (11 listed)
- Patients with any chronic diseases except COPD which in the opinion of the investigator may interfere with study evaluation or optimal participation in the study.
- Patients with a history of chronic lung disease other than COPD, including (but not limited to) active tuberculosis, lung cancer, clinically significant bronchiectasis, primary pulmonary hypertension, sarcoidosis, interstitial lung disease, asthma (other than asthma COPD overlap), severe cor pulmonale.
- Patients with acute coronary syndrome(ACS) or acute left heart failure within the 6 months prior to visit 0. Patients accepted Coronary interventional therapy or coronary artery bypass grafting due to ACS within the 3 months prior to visit 0.
- Patients with uncontrolled hypertension.
- Patients who started oral >10mg prednisolone or Equivalent systemic corticosteroids within 4 weeks prior to Visit 1. Or patients who received antibiotics within 4 weeks prior to Visit 1. Or patients who received standard treatment for COPD within 4 weeks prior to Visit 1. Or use of other investigational drugs within 5 half-lives of enrollment, or within 30 days, whichever is longer.
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 |
|---|---|---|
| Arbidoloral | Drug | arbidol |
| Placeboscontrole | Drug | control |
Primary outcome
Frequency of moderate or severe acute exacerbation in patients with chronic obstructive pulmonary disease
Time frame: 52 weeks
Frequency of moderate or severe acute exacerbation in patients with chronic obstructive pulmonary disease
8 secondary outcomes
The frequency of Acute exacerbation of patients leads to hospitalization
Time frame: 52 weeks
The intervals to the next acute exacerbation after the first use of the study drug
Time frame: 52 weeks
To assess the change of FEV1 from baseline
Time frame: 52 weeks
Mean duration of moderate or severe acute exacerbation in chronic obstructive pulmonary disease
Time frame: 52 weeks
Throat swab and virus separation experiment to detect the composition of respiratory viruses in patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) requiring hospitalization
Time frame: 52 weeks
Number of unscheduled visits to a clinic for COPD exacerbation
Time frame: 52 weeks
Number of emergency room visits for AECOPD
Time frame: 52 weeks
Number of hospitalizations due to AECOPD
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 20 Jul 2025.
- Background: PubMed 27028990Ko FW, Chan KP, Hui DS, Goddard JR, Shaw JG, Reid DW, Yang IA. Acute exacerbation of COPD. Respirology. 2016 Oct;21(7):1152-65. doi: 10.1111/resp.12780. Epub 2016 Mar 30.
- Background: PubMed 25066886Zwaans WA, Mallia P, van Winden ME, Rohde GG. The relevance of respiratory viral infections in the exacerbations of chronic obstructive pulmonary disease-a systematic review. J Clin Virol. 2014 Oct;61(2):181-8. doi: 10.1016/j.jcv.2014.06.025. Epub 2014 Jul 4.
- Background: PubMed 22028179Brooks MJ, Burtseva EI, Ellery PJ, Marsh GA, Lew AM, Slepushkin AN, Crowe SM, Tannock GA. Antiviral activity of arbidol, a broad-spectrum drug for use against respiratory viruses, varies according to test conditions. J Med Virol. 2012 Jan;84(1):170-81. doi: 10.1002/jmv.22234. Epub 2011 Oct 25.
- Individual participant dataSharing planned: No
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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.
Li Zhao, Doctor principal investigator
Shengjing Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Arbidol in people with COPD Patients, run by Shengjing Hospital 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 8 inclusion and 11 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 20 Jul 2025. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Frequency of moderate or severe acute exacerbation in patients with chronic obstructive pulmonary disease (time frame: 52 weeks). 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 NCT03851991, which also lists 3 linked publications.
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 20 Jul 2025.