Arbidol for COPD Exacerbations
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|ClinicalTrials.gov Identifier: NCT03851991|
Recruitment Status : Recruiting
First Posted : February 22, 2019
Last Update Posted : October 11, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|COPD Patients||Drug: Arbidol Drug: Placebos||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||990 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A 52-week Multicenter, Randomized, Double-blind, Placebo-controlled, Prospective Study to Evaluate the Efficacy and Safety of Arbidol Hydrochloride Capsules in Reducing the Frequency of Moderate or Severe Acute Exacerbations in Patients With Chronic Obstructive Pulmonary Disease.|
|Actual Study Start Date :||August 30, 2019|
|Estimated Primary Completion Date :||August 31, 2021|
|Estimated Study Completion Date :||August 31, 2022|
Active Comparator: arbidol
200mg, three times per day, for 2-5 Days.
Placebo Comparator: Placebos
two capsules, three times per day, for 2-5 Days.
- Frequency of moderate or severe acute exacerbation in patients with chronic obstructive pulmonary disease [ Time Frame: 52 weeks ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03851991
|Contact: Yu Li, Masterfirstname.lastname@example.org|