Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of Acute Bronchitis in Adult Patients

The design is a multi‐center, double‐blind, placebo‐controlled, randomized parallel‐groupclinical trial.The trial will include outpatients of both sexes aged 18 to 64 years with clinicalmanifestations of acute bronchitis (AB) with a duration of symptoms (productive cough +one or more symptoms: dry wheezing in the lungs, "discomfort" in the chest, shortness ofbreath, fever) of less than 72 hours. Patients will be enrolled during the period ofseasonal incidence of acute respiratory viral infections (ARVI). After the patient signsthe information sheet and informed consent form for participation in the clinical trial,the medical history will be collected, thermometry, pulse oximetry, objectiveexamination, laboratory tests (complete blood count and blood biochemistry,quantification of C‐reactive protein ) will be performed. Associated diseases andconcomitant therapy are recorded. Before the start of therapy, a nasopharyngeal swab istaken for subsequent PCR test and verification of respiratory viruses.If there are indications (detecting an increased heart rate of more than 100 bpm,tachypnea with a rate of more than 24 breaths per minute, or body temperature >38˚C, orauscultation of moist rales on the affected side during examination of the patient), aposteroanterior and lateral X‐ray examination of the chest organs or CT of the chestorgans are performed to exclude pneumonia. It is allowed to use data from X‐Ray/CTexamination of the patient obtained no later than 72 hours before their inclusion in thetrial.Based on complaints, physical and instrumental examination, chronic pathology of thebronchopulmonary system and acute infectious process with lesion of the pulmonary tissueare excluded. In the presence of characteristic clinical symptoms of acute lesion of thebronchial tree and data obtained during examination, this allows a diagnosis of acutebronchitis to be made. Prior to the start of therapy, a nasopharyngeal swab is taken forsubsequent PCR test and verification of respiratory viruses.The severity of AB symptoms is assessed using the Bronchitis Severity Scale (BSS),Appendix 1.If a patient meets the inclusion criteria are does not meet the exclusion criteria atVisit 1 (Day 1), they will be randomized to one of two groups: patients in Group 1 willreceive Raphamin according to the regimen for 5 days; patients in Group 2 will receivePlacebo according to the Raphamin administration regimen for 5 days.The trial uses an electronic patient diary (EPD) where the symptoms of acute bronchitis(cough, sputum, chest pain during coughing) are assessed daily, and the IntegrativeMedicine Outcome Scale (IMOS), Appendix 4 is completed. Additionally, any possibledeterioration in the patient's clinical condition is recorded in the diary (ifapplicable, for safety assessment / recording of adverse events). The investigatorprovides instructions to the patient on completing the diary at Visit 1.Face‐to‐face visits are planned in the trial: Visit 1 (Day 1), Visit 2 (Day 4±1), Visit 3(Day 7±1), and a phone Visit 4 (day 14±1). Patients visit the physician, or the physicianvisits patients, at a medical center or at home. In case of deterioration in thepatient's condition or at the physician's decision, an unscheduled visit may be conductedthroughout the trial.During Visits 1‐3, the physician performs a physical examination, records vital signs(RR, HR, BP, body temperature), performs pulse oximetry, records the dynamics of diseasesymptoms (according to the BSS), completes the European Quality of Life Instrument(EQ‐5D) (Appendix 3), records the administration of basic and concomitant medications. AtVisits 2 and 3, the physician monitors the completion of the EPD. At Visit 3, complianceis assessed. At Visit 4 (telephone visit), the physician assesses safety, collectsinformation about the patient's condition, the presence/absence of complications, the useof antibacterial drugs, and the presence/absence of patient's hospitalization.During the trial, patients may receive baseline therapy as indicated: a mucolytic fortight productive cough (Lazolvan® MAX, 1 capsule of 75 mg once daily for tight productivecough), analgesics and antipyretics for hyperthermia above 38°C (ibuprofen and/orparacetamol), therapy for concomitant diseases, excluding medications specified in the"Prohibited concomitant therapy" section.