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

Multicenter, Double Blind, Placebo-controlled, Randomized, Parallel-group Clinical Trial of the Efficacy and Safety of Raphamin in the Treatment of Acute Bronchitis in Adult Patients

The goal of this clinical trial is to learn if Raphamin works to treat acute bronchitis in adults. It will also learn about the efficacy and the safety of Raphamin. The main questions it aims to answer are:

Will treatment with Rafamine contribute to a faster resolution of acute bronchitis symptoms, reduce the severity of the disease, and prevent the development of complications requiring antibacterial therapy compared to placebo therapy? Researchers will compare Raphamin to a placebo (a look-alike substance that contains no drug) to see if Raphamin works to treat acute bronchitis.

Participants will:

Take Raphamin or a placebo for 5 days. On the first day of treatment 8 tablets of Raphamin or a placibo should be taken using the following regimen: 1 tablet every 30 minutes for the first 2 hours (5 tablets in total for 2 hours), then 1 more tablet 3 times at equal intervals during the same day. On day 2 and onwards, 1 tablet should be taken 3 times a day.

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). The study uses an electronic patient diary (EPD) in which symptoms of acute bronchitis (cough, sputum, chest pain during coughing) are assessed daily.

Study Overview

• Status: Recruiting
• Conditions: Bronchitis; Acute Bronchitis
• Intervention / Treatment: Drug: Placebo; Drug: Raphamin

Detailed Description

The design is a multi-center, double-blind, placebo-controlled, randomized parallel-group clinical trial.

The trial will include outpatients of both sexes aged 18 to 64 years with clinical manifestations 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 of breath, fever) of less than 72 hours. Patients will be enrolled during the period of seasonal incidence of acute respiratory viral infections (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, pulse oximetry, objective examination, laboratory tests (complete blood count and blood biochemistry, quantification of C-reactive protein ) will be performed. Associated diseases and concomitant therapy are recorded. Before the start of therapy, a nasopharyngeal swab is taken 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, or auscultation of moist rales on the affected side during examination of the patient), a posteroanterior and lateral X-ray examination of the chest organs or CT of the chest organs are performed to exclude pneumonia. It is allowed to use data from X-Ray/CT examination of the patient obtained no later than 72 hours before their inclusion in the trial.

Based on complaints, physical and instrumental examination, chronic pathology of the bronchopulmonary system and acute infectious process with lesion of the pulmonary tissue are excluded. In the presence of characteristic clinical symptoms of acute lesion of the bronchial tree and data obtained during examination, this allows a diagnosis of acute bronchitis to be made. Prior to the start of therapy, a nasopharyngeal swab is taken for subsequent 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 at Visit 1 (Day 1), they will be randomized to one of two groups: patients in Group 1 will receive Raphamin according to the regimen for 5 days; patients in Group 2 will receive Placebo 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 Integrative Medicine Outcome Scale (IMOS), Appendix 4 is completed. Additionally, any possible deterioration in the patient's clinical condition is recorded in the diary (if applicable, for safety assessment / recording of adverse events). The investigator provides 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 physician visits patients, at a medical center or at home. In case of deterioration in the patient's condition or at the physician's decision, an unscheduled visit may be conducted throughout 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 disease symptoms (according to the BSS), completes the European Quality of Life Instrument (EQ-5D) (Appendix 3), records the administration of basic and concomitant medications. At Visits 2 and 3, the physician monitors the completion of the EPD. At Visit 3, compliance is assessed. At Visit 4 (telephone visit), the physician assesses safety, collects information about the patient's condition, the presence/absence of complications, the use of antibacterial drugs, and the presence/absence of patient's hospitalization.

During the trial, patients may receive baseline therapy as indicated: a mucolytic for tight productive cough (Lazolvan® MAX, 1 capsule of 75 mg once daily for tight productive cough), analgesics and antipyretics for hyperthermia above 38°C (ibuprofen and/or paracetamol), therapy for concomitant diseases, excluding medications specified in the "Prohibited concomitant therapy" section.

• Study Type: Interventional
• Enrollment (Estimated): 308
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Mikhail Putilovskiy; Phone Number: 302 +74952761571; Email: PutilovskiyMA@materiamedica.ru

Study Locations

• Russia
  • Aramil, Russia, 624000
    • Recruiting
    • Aramil City Hospital
    • Contact: Maria Evsina, MD
    • Principal Investigator: Maria Evsina, MD
  • Gatchina, Russia, 188300
    • Recruiting
    • Gatchina Clinical Interdistrict Hospital
    • Contact: Asmik Asatryan, MD
    • Principal Investigator: Asmik Asatryan, MD
  • Izhevsk, Russia, 426063
    • Not yet recruiting
    • City Clinical Hospital No # 9 of the Ministry of Health of the Udmurt Republic
    • Contact: Andrey Yezhov, Prof.
    • Principal Investigator: Andrey Yezhov, Prof.
  • Kazan', Russia, 420012
    • Recruiting
    • Kazan State Medical University/Department of Infectious Diseases
    • Contact: Irina Kravchenko, Prof.
    • Principal Investigator: Irina Kravchenko, Prof.
  • Kazan', Russia, 420012
    • Recruiting
    • Kazan State Medical University/Department of Internal Medicine
    • Contact: Rustem Khamitov, Prof.
    • Principal Investigator: Rustem Khamitov, Prof.
  • Moscow, Russia, 105094
    • Not yet recruiting
    • Main Military Clinical Hospital named after Academician N.N. Burdenko/Therapeutic department
    • Contact: Andrey Zaitsev, Prof.
    • Principal Investigator: Andrey Zaitsev, Prof.
  • Moscow, Russia, 119991
    • Not yet recruiting
    • First Moscow State Medical University named after I.M. Sechenov/University Clinical Hospital # 4
    • Contact: Mikhail Osadchuk, MD, PhD
    • Principal Investigator: Mikhail Osadchuk, MD, PhD
  • Nizhny Novgorod, Russia, 603155
    • Recruiting
    • LLC "Persona Group of Companies"
    • Contact: Natalia Eremina, MD, PhD
    • Principal Investigator: Natalia Eremina, MD, PhD
  • Perm, Russia, 614070
    • Recruiting
    • LLC "Professorial Clinic"
    • Contact: Svetlana Teplykh, MD, PhD
    • Principal Investigator: Svetlana Teplykh, MD, PhD
  • Pyatigorsk, Russia, 357502
    • Recruiting
    • LLC "Ultrasound clinic 4D"
    • Contact: Tatyana Rushnichenko, MD
    • Principal Investigator: Tatyana Rushnichenko, MD
  • Rostov-on-Don, Russia, 152155
    • Recruiting
    • Rostov Central District Hospital
    • Contact: Olga Zherebtsova, MD
    • Principal Investigator: Olga Zherebtsova, MD
  • Saint Petersburg, Russia, 194156
    • Recruiting
    • LLC "Energy of Health"
    • Contact: Natalia Egorova, MD
    • Principal Investigator: Natalia Egorova, MD
  • Saint Petersburg, Russia, 197376
    • Not yet recruiting
    • Institute of Experimental Medicine
    • Contact: Svetlana Mosolova, MD
    • Principal Investigator: Svetlana Mosolova Svetlana, MD
  • Saint Petersburg, Russia, 199406
    • Recruiting
    • LLC "Meili"
    • Contact: Irina Nesterovich, MD, PhD
    • Principal Investigator: Irina Nesterovich, MD, PhD
  • Saint Petersburg, Russia, 194356
    • Recruiting
    • LLC "Medical Clinic"
    • Contact: Maxim Bushara, MD
    • Principal Investigator: Maxim Bushara, MD
  • Saint Petersburg, Russia, 199155
    • Recruiting
    • City Polyclinic # 3
    • Contact: Vera Panezhina, MD
    • Principal Investigator: Vera Panezhina, MD
  • Saint Petersburg, Russia, 199178
    • Recruiting
    • City Polyclinic # 4
    • Contact: Alexandra Rykova, MD
    • Principal Investigator: Alexandra Rykova, MD
  • Saint Petersburg, Russia, 191036
    • Recruiting
    • St. Petersburg Research Institute of Phthisiopulmonology
    • Contact: Yana Startseva, MD
    • Principal Investigator: Yana Startseva, MD
  • Saint Petersburg, Russia, 192071
    • Recruiting
    • City Polyclinic # 44
    • Contact: Ruslan Sardinov, MD, PhD
    • Principal Investigator: Ruslan Sardinov, MD, PhD
  • Saint Petersburg, Russia, 194354
    • Recruiting
    • LLC "Medical Center "Reavita Med St. Petersburg"
    • Contact: Veronica Popova, MD, PhD
    • Principal Investigator: Veronica Popova, MD, PhD
  • Saint Petersburg, Russia, 195427
    • Recruiting
    • City Polyclinic # 112
    • Contact: Elizaveta Antonova, MD
    • Principal Investigator: Elizaveta Antonova, MD
  • Saint Petersburg, Russia, 196158
    • Recruiting
    • LLC "Starry Clinic"
    • Contact: Dmitry Shkarbul, MD
    • Principal Investigator: Dmitry Shkarbul, MD
  • Saint Petersburg, Russia, 197110
    • Recruiting
    • LLC "YAKUSI Clinic"
    • Contact: Varvara Popova, MD, PhD
    • Principal Investigator: Varvara Popova, MD, PhD
  • Saint Petersburg, Russia, 197198
    • Recruiting
    • City Polyclinic # 34
    • Contact: Yulia Drozdova, MD
    • Principal Investigator: Yulia Drozdova, MD
  • Saint Petersburg, Russia, 199106
    • Recruiting
    • Pokrovskaya City Hospital
    • Contact: Oleg Khmelnitsky, MD, PhD
    • Principal Investigator: Oleg Khmelnitsky, MD, PhD
  • Samara, Russia, 443056
    • Recruiting
    • Samara City Hospital # 4
    • Contact: Elena Borodulina, Prof.
    • Principal Investigator: Elena Borodulina, Prof.
  • Samara, Russia, 443099
    • Recruiting
    • Samara State Medical University/Department of Infectious Diseases with Epidemiology
    • Contact: Dmitry Konstantinov, MD, PhD
    • Principal Investigator: Dmitry Konstantinov, MD, PhD
  • Saratov, Russia, 410012
    • Recruiting
    • Saratov State Medical University named after V.I. Razumovsky/Department of Faculty Therapy
    • Contact: Yuri Schwartz, Prof.
    • Principal Investigator: Yuri Schwartz, Prof.
  • Smolensk, Russia, 214019
    • Recruiting
    • Smolensk State Medical University/Medical and Consultative Center "Academy of Health"
    • Contact: Roman Kozlov, Prof.
    • Principal Investigator: Roman Kozlov, Prof.
  • Stavropol, Russia, 355000
    • Recruiting
    • Scientific Medical Center of General Therapy and Pharmacology
    • Contact: Olga Ukhanova, Prof.
    • Principal Investigator: Olga Ukhanova, Prof.
  • Ulyanovsk, Russia, 432063
    • Recruiting
    • Ulyanovsk Regional Clinical Hospital
    • Contact: Andrey Peskov, Prof.
    • Principal Investigator: Andrey Peskov, Prof.
  • Voronezh, Russia, 394066
    • Recruiting
    • Voronezh Regional Clinical Hospital # 1/Pulmonology department
    • Contact: Natalia Kostina, MD, PhD
    • Principal Investigator: Natalia Kostina, MD, PhD
  • Yaroslavl, Russia, 1150040
    • Recruiting
    • LLC "Medical Center for Diagnostics and Prevention Plus"
    • Contact: Ekaterina Melnikova, MD,PhD
    • Principal Investigator: Ekaterina Melnikova, MD,PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Male and female patients aged 18 to 64 years, inclusive.
2. Confirmed diagnosis of acute bronchitis (AB) based on the presence of productive cough and one or more symptoms (wheezing in the lungs, chest "discomfort", shortness of breath, fever).
3. The BSS score of at least 5 and no more than 15 points.
4. Duration of AB symptoms does no more than 72 hours.
5. Seasonal incidence of acute respiratory viral infections.
6. Availability of a patient information sheet and an informed consent form for participation in the clinical trial signed by the patient.
7. Patients who have agreed to use a reliable method of contraception during the study (for men and women of reproductive potential).

Exclusion Criteria:

1. History of chronic obstructive pulmonary disease, chronic bronchitis, asthma, bronchiectasis, or pulmonary emphysema.
2. Suspected pneumonia or bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) requiring antibiotics, starting on the first day of illness.
3. Suspected infiltrative pulmonary tuberculosis, pulmonary embolism, pulmonary infarction, drug-induced (toxic) pneumopathy, foreign body aspiration, sarcoidosis, pulmonary alveolar proteinosis, lipoid pneumonia, or atelectasis.
4. History of immunopathological diseases: systemic vasculitis, lupus pneumonitis, allergic bronchopulmonary aspergillosis, obliterating bronchiolitis, idiopathic pulmonary fibrosis, eosinophilic pneumonia, bronchocentric granulomatosis.
5. Chronic heart failure with functional classes III and IV (according to the classification of the New York Heart Association, 1964).
6. Metabolic disorders (obesity grades 2-3).
7. History of chronic kidney disease (classes C3-5 A3); liver failure (class C according to Child-Pugh); neurological conditions (neuromuscular, neurocognitive disorders, epilepsy); hemoglobinopathy.
8. Primary and/or secondary immunodeficiency (HIV infection, administration of immunosuppressive drugs, etc.).
9. Surgery of any localization within the last 3 months.
10. Clinical symptoms of severe influenza/ARI requiring hospitalization .
11. Acute respiratory failure.
12. History/suspected oncological disease of any location (except for benign neoplasms).
13. Exacerbation or decompensation of chronic diseases that affect the patient's ability to participate in the clinical trial, including diabetes mellitus.
14. Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
15. Pregnancy, breastfeeding, and childbirth less than 3 months prior to study inclusion.
16. Hypersensitivity to any component of the medications used in the treatment.
17. Patients who have taken medications listed in the "Prohibited Concomitant Medication" section in the previous 1 month prior to study inclusion or who require medications prohibited for use in this study.
18. Patients who, in the investigator's opinion, will not comply with study monitoring requirements or with the study drugs administration schedule.
19. History of mental illness, alcoholism, or drug abuse that, in the investigator's opinion, will interfere with successful compliance with study procedures.
20. Participation in other clinical trials within 3 months prior to study inclusion.
21. The patient is a member of the center's research staff directly involved in the study and is an immediate family member of the investigator. Immediate family members are defined as spouses, parents, children, or siblings, regardless of whether they are biological or adopted.
22. The patient is employed by NPF MATERIA MEDICA HOLDING LLC, i.e., is an employee of the company, a temporary contract worker, or a designated official responsible for the study, or is an immediate family member of one of these individuals..

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Raphamin; Per os without food. The tablet should be kept in mouth until completely dissolved. On day 1 of treatment, 8 tablets should be taken using the following regimen: 1 tablet every 30 minutes for the first 2 hours (5 tablets in total for 2 hours), then 1 more tablet 3 times at equal intervals during the same day. On day 2 and onwards, 1 tablet should be taken 3 times a day. The duration of treatment is 5 days.	Drug: Raphamin; Oral administration
Placebo Comparator: Placebo; Placebo using the Raphamin dosage regimen.	Drug: Placebo; Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with the BSS score of 4 points or less	To evaluate and compare the proportion of patients with the Bronchitis Severity Scale (BSS) score of 4 points or less in two groups (Raphamin and Placebo) on day 4 of treatment.	On day 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the total BSS score	To assess and compare the change in the total BSS score in two groups (Raphamin and Placebo) compared to baseline over 7 days.	7 days
Proportion of patients with the BSS score of 4 points or less	To evaluate and compare the proportion of patients with the BSS score of 4 points or less in two groups (Raphamin and Placebo) on observation day 7.	On day 7
Proportion of patients with a decrease in the BSS score by 5 points or more	To evaluate and compare the proportion of patients with a decrease in the BSS score by 5 points or more in two groups (Raphamin and Placebo) as compared to baseline on observation days 4 and 7.	On 4 and 7 days
Change in the severity of acute bronchitis symptoms	To evaluate and compare the change in the severity of acute bronchitis symptoms (cough, sputum, chest pain during cough) in two groups (Raphamin and Placebo) based on the EPD data as compared to baseline throughout the entire period of treatment and follow-up (14 days).	14 days
Proportion of patients with no individual symptoms (cough, sputum, wheezing, chest pain during cough, shortness of breath) according to the BSS	To evaluate and compare the proportion of patients with no individual symptoms (cough, sputum, wheezing, chest pain during cough, shortness of breath) according to the BSS in two groups (Raphamin and Placebo) on observation days 4 and 7.	On 4 and 7 days
Time to effect of therapy according to the IMOS	To evaluate and compare the time to effect of therapy according to the Integrative Medicine Outcome Scale (IMOS) in two groups (Raphamin and Placebo) based on the EPD data.	14 days
EQ-5D total score	To evaluate and compare the European Quality of Life Instrument (EQ-5D) total score in two groups (Raphamin and Placebo) on observation days 4 and 7 as compared to baseline.	On 4 and 7 days
Proportion of patients with worsening of bronchitis requiring systemic antibacterial therapy	To evaluate and compare the proportion of patients with worsening of bronchitis requiring systemic antibacterial therapy in the Raphamin and Placebo groups.	14 days
Proportion of patients hospitalized due to worsening of acute bronchitis	To evaluate and compare the proportion of patients hospitalized due to worsening of acute bronchitis in the Raphamin and Placebo groups.	14 days
Number of participants with AEs	To evaluate and compare the presence and nature of adverse events (AE) in the Raphamin and Placebo groups during the therapy period. Based on medical records.	14 days
The intensity (severity) ofAEs	To evaluate and compare the intensity (severity) of adverse events in the Raphamin and Placebo groups during the therapy period. Based on medical records.	14 days
Causal relationship of AEs to the sudy drug	To evaluate and compare the relation to the study drug of adverse events in the Raphamin and Placebo groups during the therapy period. Based on medical records.	14 days
Outcome of AEs	To evaluate and compare the outcome of adverse events in the Raphamin and Placebo groups during the therapy period. Based on medical records.	14 days
Changes in vital signs (Blood Pressure)	Blood Pressure measured in mm Hg. Based on medical records.	14 days
Changes in vital signs (Heart Rate)	Pulse Rate measured in beats per minute. Based on medical records.	14 days
Changes in vital signs (Breathing Rate)	Respiratory Rate measured in breaths per minute. Based on medical records.	14 days

Collaborators and Investigators

• Sponsor: Materia Medica Holding

Study record dates

Study Major Dates

• Study Start (Actual): December 9, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 10, 2026
• First Submitted That Met QC Criteria: June 10, 2026
• First Posted (Actual): June 16, 2026

Study Record Updates

• Last Update Posted (Actual): June 16, 2026
• Last Update Submitted That Met QC Criteria: June 10, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Acute; Bronchitis; Adulte
• Additional Relevant MeSH Terms: Respiratory Tract Infections; Infections; Respiratory Tract Diseases; Lung Diseases; Bronchial Diseases; Lung Diseases, Obstructive; Bronchitis
• Other Study ID Numbers: MMH-407-012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No