A Study to Investigate the Biomarkers of Hemay005 in Adult Participants With Moderate to Severe COPD
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorGanzhou Hemay Pharmaceutical Co., Ltd
About this trial
A Multicenter, Randomized, Double-blind, Single-dummy, positive drug and placebo-controlled, Parallel Group, Phase 2a Study to Evaluate the Efficacy and Safety of Hemay005 in Adults with Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age at least 40 years old at the time of signing the informed consent form, both gender;
Subjects with an established diagnosis of COPD (according to GOLD 2025) at least 12 months before the screening visit, with chronic bronchitis (defined as productive cough for at least 3 months in each of the prior two consecutive years) and/or with chronic productive cough at least 12 months prior to screening;
Confirmed diagnosis of chronic obstructive pulmonary disease at the screening visit, FEV1 (forced expiratory volume in 1 second)/FVC (forced vital capacity) ratio<70% after albuterol use, and FEV1 after albuterol use>30% predicted of normal value and equal or smalled than 70% predicted value at the screening visit;
Subjects on regular maintenance therapy: inhaled glucocorticoids (ICS), LAMA, or LABA, or any combination thereof. Received maintenance therapy for at least 6 months prior to screening; Maintenance therapy must not change the dosage of these drugs from 28 days before signing the informed consent form until the end of the trial (16 weeks or safety visit after early withdrawal).
Disqualifiers
Subjects with a prior history of asthma or concurrent diagnosis of asthma, with or without active disease, are excluded.
Subjects with a moderate or severe COPD exacerbation i.e. resulting in the use of systemic corticosteroids (oral/IV/IM corticosteroids) and/or antibiotics or need for hospitalisation or a lower respiratory tract infection 6 weeks prior to screening.
Diseases that in the opinion of the investigator may interfere with clinical assessments, such as bronchiectasis, sarcoidosis, cystic fibrosis, pulmonary hypertension, interstitial lung disease, bronchiolitis, pneumonectomy, lung cancer, congestive heart failure, diffuse bronchiolitis, silicosis, etc.
COPD with emphysema phenotype according to the investigator's judgment and/or medical history records (emphysema phenotype is defined as alveolar destruction leading to permanent airway obstruction, in addition to cough and sputum, subjects usually have severe symptoms of dyspnea, shortness of breath, etc.); or have alpha1-antitrypsin deficiency.
Trial design
Design model
Parallel
Treatments tested in this trial
Hemay005 tablets
DrugSubjects take Hemay005 tablets for 12 weeks.
Roflumilast Oral Tablet
DrugSubjects take roflumilast tablet for 12 weeks.
Placebo tablet
DrugSubjects take placebo tablet for 12 weeks.
Treatment groups
120 Participants
are divided into 3 treatment groupsGroup A: Hemay005 groupExperimental treatment 1 intervention
Group B: Placebo groupPlacebo comparator 1 intervention
Group C: Roflumilast groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Sputum biomarkers
Alpha-2 macroglobulin, Interleukin 1b, Leukotriene B4, Myeloperoxidase, Neutrophil elastase, Interleukin 6, Interleukin 8, etc.
Time frame
Change from baseline to week 42
Sputum cell count
Total cell count Absolute and percent of neutrophils, eosinophils, macrophages and lymphocytes differential cell count.
Time frame
Change from baseline to week 43
Blood Biomarkers
Interleukin 1b, Interleukin 33, CXC motif chemokine ligand 1, Interleukin 8, Myeloperoxidase, Interleukin 6, Monocyte chemotactic protein 1, Macrophage inflammatory protein 1b, Matrix Metalloproteinase 9, etc
Time frame
Change from baseline to week 4Secondary outcomes
1
Sputum biomarkers
Alpha-2 macroglobulin, Interleukin 1b, Leukotriene B4, Myeloperoxidase, Neutrophil elastase, Interleukin 6, Interleukin 8, etc
Time frame
Change from baseline to week 122
Sputum cell count
Total cell count Absolute and percent of neutrophils, eosinophils, macrophages and lymphocytes differential cell count.
Time frame
Change from baseline to week 123
Blood Biomarkers
Interleukin 1b, Interleukin 33, CXC motif chemokine ligand 1, Interleukin 8, Myeloperoxidase, Interleukin 6, Monocyte chemotactic protein 1, Macrophage inflammatory protein 1b, Matrix Metalloproteinase 9, etc
Time frame
Change from baseline to week 12Sponsors and contacts
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Source ClinicalTrials.gov
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