A Phase 3 interventional study of Raphamin and Placebo in Bronchitis and Acute Bronchitis, sponsored by Materia Medica Holding. Recruiting at 33 sites in Russia. Open to participants aged 18 Years to 64 Years. Per ClinicalTrials.gov, last updated 2026-06-29.
Sponsored by Materia Medica Holding · Phase 3, Interventional, and Treatment
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.
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.
156 studies on the registry are indexed under Bronchitis; 21 are open to participants now.
This study's planned enrollment of 308 is above the median of 185 across 105 interventional studies indexed under Bronchitis.
Browse Bronchitis studies →Materia Medica Holding is the lead sponsor of 43 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 using the Raphamin dosage regimen.
Drug: Placebo
Oral administration
Oral administration
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.
Time frame: On day 4
Change in the total Bronchitis Severity Scale, (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. 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.
Time frame: 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.
Time frame: 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.
Time frame: On 4 and 7 days
Change in the severity of acute bronchitis symptoms (cough, sputum, and chest pain)
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). Three key symptoms (cough, sputum, and chest pain) are each assessed on a scale from 0 to 4 points.Outcome Interpretation: higher scores mean a worse outcome (greater severity of the symptom), where 0 represents the absence of the symptom and 4 represents the maximum severity.
Time frame: 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.
Time frame: 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.
Time frame: 14 days
European Quality of Life Instrument (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. Minimum and maximum values: 0 to 100 points. Нigher scores mean a better outcome.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 14 days
Changes in vital signs (Blood Pressure)
Blood Pressure measured in mm Hg. Based on medical records.
Time frame: 14 days
Changes in vital signs (Heart Rate)
Pulse Rate measured in beats per minute. Based on medical records.
Time frame: 14 days
Changes in vital signs (Breathing Rate)
Respiratory Rate measured in breaths per minute. Based on medical records.
Time frame: 14 days
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Studies of the drug tested here: MMH-407