The purpose of this clinical trial is to assess the efficacy and safety of HTMC0658 tablets in treating subjects with chronic rhinosinusitis without nasal polyps (CRSsNP).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
HTMC0658 tablet
Luoyang First People's Hospital
Luoyang, Henan, China
RECRUITINGChange from baseline in Lund-MacKay (LMK) score on sinus CT scan at Week 12
Lund-MacKay (LMK) score for CT scan of the sinuses: This score evaluates the left and right maxillary sinuses, anterior ethmoid sinuses, posterior ethmoid sinuses, sphenoid sinuses, frontal sinuses, and the ostiomeatal complex. Scoring criteria are as follows: For the sinuses: 0 = no abnormality, 1 = partially opacified, 2 = completely opacified; For the ostiomeatal complex: 0 = no obstruction, 2 = obstruction. The score for each side ranges from 0 to 12, with a total possible score of 0 to 24.
Time frame: Baseline to 12 weeks
Change from baseline in Composite Symptom Score (CSS) at Weeks 4, 8, and 12
Composite Symptom Score (CSS) for Chronic Rhinosinusitis: These symptoms are categorized into three types: nasal congestion, facial pain/pressure, and nasal discharge. The scoring criteria are as follows: 0 = no symptoms (absence of noticeable signs or symptoms), 1 = mild symptoms (presence of signs or symptoms that are mild and tolerable), 2 = moderate symptoms (signs or symptoms that are noticeable and uncomfortable but tolerable), 3 = severe symptoms (signs or symptoms that are intolerable and interfere with daily activities and/or sleep). The total score ranges from 0 to 9.
Time frame: baseline to 4, 8 and 12 weeks
Change from baseline in the Sino-Nasal Outcome Test-22 (SNOT-22) scale score at Weeks 4, 8, and 12
The SNOT-22 is a subject-completed questionnaire that consists of 22 symptoms and social/emotional consequences of their nasal disorder across several domains including: rhinologic, extra-nasal rhinologic, ear/facial pain, psychological dysfunction, and sleep dysfunction. Total scores range from 0-110. Each item is rated as follows: 0=no problem, 1=very mild problem, 2=mild or slight problem, 3=moderate problem, 4=severe problem, 5=problem as bad as it can be, and total scores are calculated by adding scores together.
Time frame: baseline to 4, 8, and 12 weeks
Change from baseline in the Visual Analog Scale (VAS) score for the severity of rhinosinusitis at Weeks 4, 8, and 12
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Visual Analogue Scale (VAS) for the Severity of Chronic Rhinosinusitis: Draw a 10 cm straight line on a piece of white paper. Label one end as "No Disturbance" and the other end as "The Worst Disturbance That Can Be Imagined" to create the VAS. The subject marks a point on the line corresponding to the severity of their sinusitis symptoms. The distance from the starting point to the marked point represents the quantified severity of the symptoms.
Time frame: baseline to 4, 8, and 12 weeks
Change from baseline in Nasal Congestion Score (NCS) at Weeks 4, 8, and 12
Nasal Congestion Score: The scoring criteria are as follows: 0 = No symptoms (no obvious signs/symptoms), 1 = Mild symptoms (signs/symptoms exist but are mild and tolerable), 2 = Moderate symptoms (signs/symptoms are obvious, causing discomfort but still tolerable), 3 = Severe symptoms (signs/symptoms are unbearable, affecting daily activities and/or sleep). The total score ranges from 0 to 3.
Time frame: baseline to 4, 8, and 12 weeks
Patient Global Impression of Change (PGIC) scale score at Week 12
The global impression of change will be assessed using a subject-completed PGIC scale, which ranges from 1 to 7: 1 - Very much improved, 2 - Much improved, 3 - Minimally improved, 4 - No change, 5 - Minimally worse, 6 - Much worse, 7 - Very much worse.
Time frame: 12 weeks
Proportion of subjects requiring rescue therapy (antibiotics, systemic corticosteroids, and/or nasal surgery) due to worsening of any chronic rhinosinusitis symptoms within 12 weeks.
Time frame: 12 weeks
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The incidence and severity of adverse events (AEs) and serious adverse events (SAEs), as well as changes in vital signs and laboratory test results, etc.
Time frame: baseline to 16 weeks
Plasma Concentration of HTMC0658
Time frame: Pre-dose and at multiple timepoints post-dose up to Day 30
Changes in serum neutrophil elastase (NE) concentration
Changes from baseline in serum neutrophil elastase (NE) concentration at Weeks 4, 8, and 12 of treatment.
Time frame: Baseline to 4, 8, and 12 weeks