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New drug raphamin aims to shorten bronchitis suffering

NCT ID NCT07650227

Symptom relief Sponsor: Materia Medica Holding Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 30, 2026 · Updated 2 times

Summary

This Phase 3 trial tests whether the drug Raphamin can help adults with acute bronchitis recover faster. About 308 participants will take either Raphamin or a placebo for 5 days. Researchers will track symptoms like cough and chest pain to see if Raphamin reduces illness duration and severity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Raphamin
What this could lead to
If it works, this could provide a new treatment option to help adults recover faster from acute bronchitis and reduce symptom severity.
What could go wrong
This is a Phase 3 trial, but acute bronchitis often resolves on its own, so the benefit over placebo may be small. The study is not yet complete, so results are uncertain.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 308 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 64 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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..

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Conditions

The condition(s) this trial relates to.

bronchitis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute bronchitis Bronchitis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    33 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aramil City Hospital

    RECRUITING

    Aramil, 624000, Russia

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

    NOT_YET_RECRUITING

    Izhevsk, 426063, Russia

  • City Polyclinic # 112

    RECRUITING

    Saint Petersburg, 195427, Russia

  • City Polyclinic # 3

    RECRUITING

    Saint Petersburg, 199155, Russia

  • City Polyclinic # 34

    RECRUITING

    Saint Petersburg, 197198, Russia

  • City Polyclinic # 4

    RECRUITING

    Saint Petersburg, 199178, Russia

  • City Polyclinic # 44

    RECRUITING

    Saint Petersburg, 192071, Russia

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

    NOT_YET_RECRUITING

    Moscow, 119991, Russia

  • Gatchina Clinical Interdistrict Hospital

    RECRUITING

    Gatchina, 188300, Russia

  • Institute of Experimental Medicine

    NOT_YET_RECRUITING

    Saint Petersburg, 197376, Russia

  • Kazan State Medical University/Department of Infectious Diseases

    RECRUITING

    Kazan', 420012, Russia

  • Kazan State Medical University/Department of Internal Medicine

    RECRUITING

    Kazan', 420012, Russia

  • LLC "Energy of Health"

    RECRUITING

    Saint Petersburg, 194156, Russia

  • LLC "Medical Center "Reavita Med St. Petersburg"

    RECRUITING

    Saint Petersburg, 194354, Russia

  • LLC "Medical Center for Diagnostics and Prevention Plus"

    RECRUITING

    Yaroslavl, 1150040, Russia

  • LLC "Medical Clinic"

    RECRUITING

    Saint Petersburg, 194356, Russia

  • LLC "Meili"

    RECRUITING

    Saint Petersburg, 199406, Russia

  • LLC "Persona Group of Companies"

    RECRUITING

    Nizhny Novgorod, 603155, Russia

  • LLC "Professorial Clinic"

    RECRUITING

    Perm, 614070, Russia

  • LLC "Starry Clinic"

    RECRUITING

    Saint Petersburg, 196158, Russia

  • LLC "Ultrasound clinic 4D"

    RECRUITING

    Pyatigorsk, 357502, Russia

  • LLC "YAKUSI Clinic"

    RECRUITING

    Saint Petersburg, 197110, Russia

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

    NOT_YET_RECRUITING

    Moscow, 105094, Russia

  • Pokrovskaya City Hospital

    RECRUITING

    Saint Petersburg, 199106, Russia

  • Rostov Central District Hospital

    RECRUITING

    Rostov-on-Don, 152155, Russia

  • Samara City Hospital # 4

    RECRUITING

    Samara, 443056, Russia

  • Samara State Medical University/Department of Infectious Diseases with Epidemiology

    RECRUITING

    Samara, 443099, Russia

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

    RECRUITING

    Saratov, 410012, Russia

  • Scientific Medical Center of General Therapy and Pharmacology

    RECRUITING

    Stavropol, 355000, Russia

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

    RECRUITING

    Smolensk, 214019, Russia

  • St. Petersburg Research Institute of Phthisiopulmonology

    RECRUITING

    Saint Petersburg, 191036, Russia

  • Ulyanovsk Regional Clinical Hospital

    RECRUITING

    Ulyanovsk, 432063, Russia

  • Voronezh Regional Clinical Hospital # 1/Pulmonology department

    RECRUITING

    Voronezh, 394066, Russia

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