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

NCT07650227 | Recruiting Phase 3

• 1 other identifier: MMH-407-012
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 33

Brief Summary

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? Investigators 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 placebo 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.

Conditions

Bronchitis; Acute Bronchitis

Keywords

Bronchitis; Acute; Adults

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with the Bronchitis Severity Scale, (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. Minimum and maximum values: 0 to 20 points. Higher scores mean a worse outcome (greater clinical severity of acute bronchitis), while lower scores indicate milder symptoms or improvement.

  On day 4

Secondary Outcomes (16)

• Change in the total Bronchitis Severity Scale, (BSS) score

  7 days

• Proportion of patients with the BSS score of 4 points or less

  On day 7

• Proportion of patients with a decrease in the BSS score by 5 points or more

  On 4 and 7 days

• Change in the severity of acute bronchitis symptoms (cough, sputum, and chest pain)

  14 days

• Proportion of patients with no individual symptoms (cough, sputum, wheezing, chest pain during cough, shortness of breath) according to the BSS

  On 4 and 7 days

Study Arms (2)

Raphamin

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

Placebo using the Raphamin dosage regimen.

Drug: Placebo

Interventions

Raphamin DRUG

Oral administration

Raphamin

Placebo DRUG

Oral administration

Placebo

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female patients aged 18 to 64 years, inclusive.
• 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).
• The BSS score of at least 5 and no more than 15 points.
• Duration of AB symptoms does no more than 72 hours.
• Seasonal incidence of acute respiratory viral infections.
• Availability of a patient information sheet and an informed consent form for participation in the clinical trial signed by the patient.
• Patients who have agreed to use a reliable method of contraception during the study (for men and women of reproductive potential).

You may not qualify if:

• History of chronic obstructive pulmonary disease, chronic bronchitis, asthma, bronchiectasis, or pulmonary emphysema.
• Suspected pneumonia or bacterial infection (including otitis media, sinusitis, urinary tract infection, meningitis, sepsis, etc.) requiring antibiotics, starting on the first day of illness.
• Suspected infiltrative pulmonary tuberculosis, pulmonary embolism, pulmonary infarction, drug-induced (toxic) pneumopathy, foreign body aspiration, sarcoidosis, pulmonary alveolar proteinosis, lipoid pneumonia, or atelectasis.
• History of immunopathological diseases: systemic vasculitis, lupus pneumonitis, allergic bronchopulmonary aspergillosis, obliterating bronchiolitis, idiopathic pulmonary fibrosis, eosinophilic pneumonia, bronchocentric granulomatosis.
• Chronic heart failure with functional classes III and IV (according to the classification of the New York Heart Association, 1964).
• Metabolic disorders (obesity grades 2-3).
• History of chronic kidney disease (classes C3-5 A3); liver failure (class C according to Child-Pugh); neurological conditions (neuromuscular, neurocognitive disorders, epilepsy); hemoglobinopathy.
• Primary and/or secondary immunodeficiency (HIV infection, administration of immunosuppressive drugs, etc.).
• Surgery of any localization within the last 3 months.
• Clinical symptoms of severe influenza/ARI requiring hospitalization .
• Acute respiratory failure.
• History/suspected oncological disease of any location (except for benign neoplasms).
• Exacerbation or decompensation of chronic diseases that affect the patient's ability to participate in the clinical trial, including diabetes mellitus.
• Malabsorption syndrome, including congenital or acquired lactase or other disaccharidase deficiency, galactosemia.
• Hypersensitivity to any component of the medications used in the treatment.

Sponsors & Collaborators

• Materia Medica Holding: lead

Study Sites (33)

Aramil City Hospital

Aramil, 624000, Russia

RECRUITING

Gatchina Clinical Interdistrict Hospital

Gatchina, 188300, Russia

RECRUITING

City Clinical Hospital No # 9 of the Ministry of Health of the Udmurt Republic

Izhevsk, 426063, Russia

NOT YET RECRUITING

Kazan State Medical University/Department of Infectious Diseases

Kazan', 420012, Russia

RECRUITING

Kazan State Medical University/Department of Internal Medicine

Kazan', 420012, Russia

RECRUITING

Main Military Clinical Hospital named after Academician N.N. Burdenko/Therapeutic department

Moscow, 105094, Russia

NOT YET RECRUITING

First Moscow State Medical University named after I.M. Sechenov/University Clinical Hospital # 4

Moscow, 119991, Russia

NOT YET RECRUITING

LLC "Persona Group of Companies"

Nizhny Novgorod, 603155, Russia

RECRUITING

LLC "Professorial Clinic"

Perm, 614070, Russia

RECRUITING

LLC "Ultrasound clinic 4D"

Pyatigorsk, 357502, Russia

RECRUITING

Rostov Central District Hospital

Rostov-on-Don, 152155, Russia

RECRUITING

St. Petersburg Research Institute of Phthisiopulmonology

Saint Petersburg, 191036, Russia

RECRUITING

City Polyclinic # 44

Saint Petersburg, 192071, Russia

RECRUITING

LLC "Energy of Health"

Saint Petersburg, 194156, Russia

RECRUITING

LLC "Medical Center "Reavita Med St. Petersburg"

Saint Petersburg, 194354, Russia

RECRUITING

LLC "Medical Clinic"

Saint Petersburg, 194356, Russia

RECRUITING

City Polyclinic # 112

Saint Petersburg, 195427, Russia

RECRUITING

LLC "Starry Clinic"

Saint Petersburg, 196158, Russia

RECRUITING

LLC "YAKUSI Clinic"

Saint Petersburg, 197110, Russia

RECRUITING

City Polyclinic # 34

Saint Petersburg, 197198, Russia

RECRUITING

Institute of Experimental Medicine

Saint Petersburg, 197376, Russia

NOT YET RECRUITING

Pokrovskaya City Hospital

Saint Petersburg, 199106, Russia

RECRUITING

City Polyclinic # 3

Saint Petersburg, 199155, Russia

RECRUITING

City Polyclinic # 4

Saint Petersburg, 199178, Russia

RECRUITING

LLC "Meili"

Saint Petersburg, 199406, Russia

RECRUITING

Samara City Hospital # 4

Samara, 443056, Russia

RECRUITING

Samara State Medical University/Department of Infectious Diseases with Epidemiology

Samara, 443099, Russia

RECRUITING

Saratov State Medical University named after V.I. Razumovsky/Department of Faculty Therapy

Saratov, 410012, Russia

RECRUITING

Smolensk State Medical University/Medical and Consultative Center "Academy of Health"

Smolensk, 214019, Russia

RECRUITING

Scientific Medical Center of General Therapy and Pharmacology

Stavropol, 355000, Russia

RECRUITING

Ulyanovsk Regional Clinical Hospital

Ulyanovsk, 432063, Russia

RECRUITING

Voronezh Regional Clinical Hospital # 1/Pulmonology department

Voronezh, 394066, Russia

RECRUITING

LLC "Medical Center for Diagnostics and Prevention Plus"

Yaroslavl, 1150040, Russia

RECRUITING

MeSH Terms

Conditions

Bronchitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases

Central Study Contacts

Mikhail Putilovskiy

CONTACT

+74952761571; PutilovskiyMA@materiamedica.ru

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, double blind, placebo-controlled, randomized, parallel-group

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 16, 2026
• Study Start: December 9, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: June 29, 2026

Record last verified: 2026-03

Locations

RU (33)