Multicenter double-blind placebo-controlled randomized in parallel groups clinical trial of the efficacy and safety of Raphamin in the treatment of acute rhinosinusitis in adult patients.
A multicenter, double-blind, placebo-controlled, randomized, parallel-group clinical trial. The trial will enroll outpatients of either gender aged 18 to 75 years with clinical manifestations of acute rhinosinusitis (ARS) within the first 48 hours after the disease onset. Patient recruitment will be conducted during the seasonal incidence of acute respiratory viral infection (ARVI). After the patient signs the information sheet and informed consent form for participation in the clinical trial, the medical history will be collected, thermometry, objective examination, laboratory tests will be performed, concomitant diseases and concomitant therapy will be recorded. The severity of ARS symptoms will be assessed using Major Symptom Score (MSS). Initially (Day 1) and on Visits 2 (Day 4) and 3 (Day 7), the patient together with the investigator, fills in the MSS scale and completes the Sino-Nasal Outcome Test questionnaire for assessing the quality of life of patients with diseases of the nose and paranasal sinuses (SNOT-22). If all inclusion criteria are met and there no any exclusion criteria, at Visit 1 (Day 1), the patient is randomized into one of two groups: Group 1 patients will receive Raphamin according to the dosage regimen for 5 days; Group 2 patients will receive Placebo using the Raphamin dosage regimen for 5 days. The trial uses an electronic patient diary (EPD) where the patient daily morning and evening will make records axillary body temperature (measured with a classic mercury-free thermometer) and symptoms of the disease (according to the MSS). In addition, administration of basic therapy drugs (if applicable) as well as any possible worsening of the patient's condition (if applicable, to assess safety / to record adverse events) should also be recorded in the patient diary. The investigator will instruct the patient on how to complete the diary. At Visit 1, the patient will record the severity of ARS symptoms and body temperature in the diary together with the physician. The patient will be observed for 14 days (screening, randomization - up to 1 day, treatment - 5 days, follow-up - up to 14 days). During the treatment and follow-up period, patients/physicians will pay 3 visits, on days 1, 4 and 7 (Visits 1, 2 and 3) - at a medical center or at home; a phone visit (Visit 4) will be on day 14. At Visits 2 and 3, the investigator performs objective examination, records changes in the disease symptoms, concomitant therapy, and controls the filling of the diary, evaluates the patient's compliance (Visit 3). At Visit 4 (a phone visit), the investigator evaluates safety, collects information about the patient's condition, the presence/absence of complications, the use of antibiotics, and the presence/absence of hospitalization of the patient. Symptomatic therapy and therapy for concomitant diseases will be permitted during the trial except for the drugs listed under "Prohibited Concomitant Treatment".
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
552
Percentage of patients with improvement of acute rhinosinusitis symptoms on day 4
Improvement of symptoms is defined as symptom score less than or equal to 1 (i.e., mild symptoms or no symptoms) for all five main symptoms (rhinorrhea / anterior nasal discharge, postnasal drip, nasal congestion, headache, facial pain/pressure) with 2 consecutive 12-hour estimates.
Time frame: On 4 day
Percentage of patients with improvement of acute rhinosinusitis symptoms on day 7
Improvement of symptoms is defined as symptom score less than or equal to 1 (i.e., mild symptoms or no symptoms) for all five main symptoms (rhinorrhea / anterior nasal discharge, postnasal drip, nasal congestion, headache, facial pain/pressure) with 2 consecutive 12-hour estimates.
Time frame: On 7 day of observation
Change in SNOT-22 total score
Change in the Sino-Nasal Outcome Test (SNOT-22) total score from baseline to days 4 and 7 of observation. 22 symptoms are assessed. Symptom severity is rated on a scale of 0 to 5 (0 - no problem, 1 - very mild problem, 2 - mild or slight problem, 3 - moderate problem, 4 - severe problem, 5 - as bad as it gets). The maximum SNOT-22 score is 110.
Time frame: On days 1, 4 and 7
Change in MSS total score
Based on patient dairy. Change in MSS total score daily from baseline to day 14 of observation. Five main symptoms are assessed: runny nose/anterior nasal discharge, postnasal drip (need to cough mucus from the throat), nasal congestion, headache, facial pain/heaviness). The severity of symptoms is assessed in points from 0 to 3 (0 - none, 1 - mild, 2 - moderate, 3 - severe). The maximum total MSS score is 15 points. The total MSS score should not be less than 8 and not more than 12 points (inclusion criterion).
Time frame: From day 1 to day 14
Change in the SNOT-22 nasal domain score
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Aramil city hospital
Aramil, Russia
ACTIVE_NOT_RECRUITINGGatchina Clinical Interdistrict Hospital
Gatchina, Russia
COMPLETEDBaltic Federal University named after Immanuel Kant
Kaliningrad, Russia
RECRUITINGKazan State Medical University/Department of Infectious Diseases
Kazan', Russia
COMPLETEDKuban State Medical University/Department of Infectious Diseases and Phthisiopulmonology
Krasnodar, Russia
TERMINATEDCity Polyclinic # 2 of the Moscow City Department of Health
Moscow, Russia
RECRUITINGFirst Moscow State Medical University named after I.M. Sechenov/Department of Ear, Nose and Throat Diseases
Moscow, Russia
COMPLETEDNational Medical Research Center of Otolaryngology
Moscow, Russia
RECRUITINGRussian University of Medicine/Department of Otolaryngology
Moscow, Russia
COMPLETEDMoscow Regional Research Clinical Institute named after M.F. Vladimirsky
Moscow, Russia
ACTIVE_NOT_RECRUITING...and 34 more locations
Change in the SNOT-22 nasal domain score from baseline to days 4 and 7 of observation.
Time frame: On days 1, 4 and 7
Percentage of patients with worsening of rhinosinusitis requiring systemic/topical antibiotics
Percentage of patients with worsening of rhinosinusitis requiring systemic/topical antibiotics. Based on medical records.
Time frame: On 14 day
Proportion of patients hospitalized due to worsening rhinosinusitis
Proportion of patients hospitalized due to worsening rhinosinusitis. Based on medical records.
Time frame: On 14 day
Percentage of patients with prolonged rhinosinusitis
The percentage of patients with prolonged rhinosinusitis (main symptoms of the disease persisting for more than 7 days, progression of symptoms). Prolonged rhinosinusitis is defined as the persistence of the main symptoms of the disease, the progression of symptoms for more than 7 days, namely, the presence of the MSS symptoms rated as 2 or more points for one or more symptoms.
Time frame: On 14 day
Number of Participants With Adverse Events (AEs)
Presence and nature of adverse events during therapy. Registration of AEs begins after the first dose of the study drug, continues throughout the entire period of study therapy, and also for 24 hours after the last dose of the study drug. Based on medical records.
Time frame: From day 1 to day 14
Severity of AEs
The intensity (severity) of adverse events. Based on medical records.
Time frame: From day 1 to day 6
Causal Relationship of AEs to the Sudy Drug
The causal relationship to the study drug of adverse events. Based on medical records.
Time frame: From day 1 to day 6
Outcome of AEs
The outcome of adverse events. Based on medical records.
Time frame: From day 1 to day 6
Changes in Vital Signs (Blood Pressure)
Blood Pressure measured in mm Hg. Based on medical records.
Time frame: On days 1, 4 and 7
Changes in Vital Signs (Heart Rate)
Pulse Rate measured in beats per minute. Based on medical records.
Time frame: On days 1, 4 and 7
Changes in Vital Signs (Breathing Rate)
Respiratory Rate measured in breaths per minute. Based on medical records.
Time frame: On days 1, 4 and 7