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

10. Juni 2026 aktualisiert von: Materia Medica Holding

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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

308

Phase

  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Russland
      • Aramil, Russland, 624000
        • Rekrutierung
        • Aramil City Hospital
        • Kontakt:
          • Maria Evsina, MD
        • Hauptermittler:
          • Maria Evsina, MD
      • Gatchina, Russland, 188300
        • Rekrutierung
        • Gatchina Clinical Interdistrict Hospital
        • Kontakt:
          • Asmik Asatryan, MD
        • Hauptermittler:
          • Asmik Asatryan, MD
      • Izhevsk, Russland, 426063
        • Noch keine Rekrutierung
        • City Clinical Hospital No # 9 of the Ministry of Health of the Udmurt Republic
        • Kontakt:
          • Andrey Yezhov, Prof.
        • Hauptermittler:
          • Andrey Yezhov, Prof.
      • Kazan', Russland, 420012
        • Rekrutierung
        • Kazan State Medical University/Department of Infectious Diseases
        • Kontakt:
          • Irina Kravchenko, Prof.
        • Hauptermittler:
          • Irina Kravchenko, Prof.
      • Kazan', Russland, 420012
        • Rekrutierung
        • Kazan State Medical University/Department of Internal Medicine
        • Kontakt:
          • Rustem Khamitov, Prof.
        • Hauptermittler:
          • Rustem Khamitov, Prof.
      • Moscow, Russland, 105094
        • Noch keine Rekrutierung
        • Main Military Clinical Hospital named after Academician N.N. Burdenko/Therapeutic department
        • Kontakt:
          • Andrey Zaitsev, Prof.
        • Hauptermittler:
          • Andrey Zaitsev, Prof.
      • Moscow, Russland, 119991
        • Noch keine Rekrutierung
        • First Moscow State Medical University named after I.M. Sechenov/University Clinical Hospital # 4
        • Kontakt:
          • Mikhail Osadchuk, MD, PhD
        • Hauptermittler:
          • Mikhail Osadchuk, MD, PhD
      • Nizhny Novgorod, Russland, 603155
        • Rekrutierung
        • LLC "Persona Group of Companies"
        • Kontakt:
          • Natalia Eremina, MD, PhD
        • Hauptermittler:
          • Natalia Eremina, MD, PhD
      • Perm, Russland, 614070
        • Rekrutierung
        • LLC "Professorial Clinic"
        • Kontakt:
          • Svetlana Teplykh, MD, PhD
        • Hauptermittler:
          • Svetlana Teplykh, MD, PhD
      • Pyatigorsk, Russland, 357502
        • Rekrutierung
        • LLC "Ultrasound clinic 4D"
        • Kontakt:
          • Tatyana Rushnichenko, MD
        • Hauptermittler:
          • Tatyana Rushnichenko, MD
      • Rostov-on-Don, Russland, 152155
        • Rekrutierung
        • Rostov Central District Hospital
        • Kontakt:
          • Olga Zherebtsova, MD
        • Hauptermittler:
          • Olga Zherebtsova, MD
      • Saint Petersburg, Russland, 194156
        • Rekrutierung
        • LLC "Energy of Health"
        • Kontakt:
          • Natalia Egorova, MD
        • Hauptermittler:
          • Natalia Egorova, MD
      • Saint Petersburg, Russland, 197376
        • Noch keine Rekrutierung
        • Institute of Experimental Medicine
        • Kontakt:
          • Svetlana Mosolova, MD
        • Hauptermittler:
          • Svetlana Mosolova Svetlana, MD
      • Saint Petersburg, Russland, 199406
        • Rekrutierung
        • LLC "Meili"
        • Kontakt:
          • Irina Nesterovich, MD, PhD
        • Hauptermittler:
          • Irina Nesterovich, MD, PhD
      • Saint Petersburg, Russland, 194356
        • Rekrutierung
        • LLC "Medical Clinic"
        • Kontakt:
          • Maxim Bushara, MD
        • Hauptermittler:
          • Maxim Bushara, MD
      • Saint Petersburg, Russland, 199155
        • Rekrutierung
        • City Polyclinic # 3
        • Kontakt:
          • Vera Panezhina, MD
        • Hauptermittler:
          • Vera Panezhina, MD
      • Saint Petersburg, Russland, 199178
        • Rekrutierung
        • City Polyclinic # 4
        • Kontakt:
          • Alexandra Rykova, MD
        • Hauptermittler:
          • Alexandra Rykova, MD
      • Saint Petersburg, Russland, 191036
        • Rekrutierung
        • St. Petersburg Research Institute of Phthisiopulmonology
        • Kontakt:
          • Yana Startseva, MD
        • Hauptermittler:
          • Yana Startseva, MD
      • Saint Petersburg, Russland, 192071
        • Rekrutierung
        • City Polyclinic # 44
        • Kontakt:
          • Ruslan Sardinov, MD, PhD
        • Hauptermittler:
          • Ruslan Sardinov, MD, PhD
      • Saint Petersburg, Russland, 194354
        • Rekrutierung
        • LLC "Medical Center "Reavita Med St. Petersburg"
        • Kontakt:
          • Veronica Popova, MD, PhD
        • Hauptermittler:
          • Veronica Popova, MD, PhD
      • Saint Petersburg, Russland, 195427
        • Rekrutierung
        • City Polyclinic # 112
        • Kontakt:
          • Elizaveta Antonova, MD
        • Hauptermittler:
          • Elizaveta Antonova, MD
      • Saint Petersburg, Russland, 196158
        • Rekrutierung
        • LLC "Starry Clinic"
        • Kontakt:
          • Dmitry Shkarbul, MD
        • Hauptermittler:
          • Dmitry Shkarbul, MD
      • Saint Petersburg, Russland, 197110
        • Rekrutierung
        • LLC "YAKUSI Clinic"
        • Kontakt:
          • Varvara Popova, MD, PhD
        • Hauptermittler:
          • Varvara Popova, MD, PhD
      • Saint Petersburg, Russland, 197198
        • Rekrutierung
        • City Polyclinic # 34
        • Kontakt:
          • Yulia Drozdova, MD
        • Hauptermittler:
          • Yulia Drozdova, MD
      • Saint Petersburg, Russland, 199106
        • Rekrutierung
        • Pokrovskaya City Hospital
        • Kontakt:
          • Oleg Khmelnitsky, MD, PhD
        • Hauptermittler:
          • Oleg Khmelnitsky, MD, PhD
      • Samara, Russland, 443056
        • Rekrutierung
        • Samara City Hospital # 4
        • Kontakt:
          • Elena Borodulina, Prof.
        • Hauptermittler:
          • Elena Borodulina, Prof.
      • Samara, Russland, 443099
        • Rekrutierung
        • Samara State Medical University/Department of Infectious Diseases with Epidemiology
        • Kontakt:
          • Dmitry Konstantinov, MD, PhD
        • Hauptermittler:
          • Dmitry Konstantinov, MD, PhD
      • Saratov, Russland, 410012
        • Rekrutierung
        • Saratov State Medical University named after V.I. Razumovsky/Department of Faculty Therapy
        • Kontakt:
          • Yuri Schwartz, Prof.
        • Hauptermittler:
          • Yuri Schwartz, Prof.
      • Smolensk, Russland, 214019
        • Rekrutierung
        • Smolensk State Medical University/Medical and Consultative Center "Academy of Health"
        • Kontakt:
          • Roman Kozlov, Prof.
        • Hauptermittler:
          • Roman Kozlov, Prof.
      • Stavropol, Russland, 355000
        • Rekrutierung
        • Scientific Medical Center of General Therapy and Pharmacology
        • Kontakt:
          • Olga Ukhanova, Prof.
        • Hauptermittler:
          • Olga Ukhanova, Prof.
      • Ulyanovsk, Russland, 432063
        • Rekrutierung
        • Ulyanovsk Regional Clinical Hospital
        • Kontakt:
          • Andrey Peskov, Prof.
        • Hauptermittler:
          • Andrey Peskov, Prof.
      • Voronezh, Russland, 394066
        • Rekrutierung
        • Voronezh Regional Clinical Hospital # 1/Pulmonology department
        • Kontakt:
          • Natalia Kostina, MD, PhD
        • Hauptermittler:
          • Natalia Kostina, MD, PhD
      • Yaroslavl, Russland, 1150040
        • Rekrutierung
        • LLC "Medical Center for Diagnostics and Prevention Plus"
        • Kontakt:
          • Ekaterina Melnikova, MD,PhD
        • Hauptermittler:
          • Ekaterina Melnikova, MD,PhD

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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..

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Raphamin

Per os ohne Essen. Die Tablette sollte im Mund bleiben, bis sie vollständig aufgelöst ist.

Am ersten Tag der Behandlung sollten 8 Tabletten nach folgendem Schema eingenommen werden: 1 Tablette alle 30 Minuten für die ersten 2 Stunden (insgesamt 5 Tabletten für 2 Stunden), dann 1 weitere Tablette dreimal in gleichen Abständen am selben Tag. Ab dem 2. Tag sollte dreimal täglich 1 Tablette eingenommen werden. Die Behandlungsdauer beträgt 5 Tage.
Arzneimittel: Raphamin
Mundverwaltung
Placebo-Komparator: Placebo
Placebo unter Verwendung des Raphamin-Dosierungsschemas.
Arzneimittel: Placebo
Orale Verabreichung

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Proportion of patients with the BSS score of 4 points or less
Zeitfenster: On day 4
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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in the total BSS score
Zeitfenster: 7 days
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
Zeitfenster: On day 7
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
Zeitfenster: On 4 and 7 days
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
Zeitfenster: 14 days
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
Zeitfenster: On 4 and 7 days
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
Zeitfenster: 14 days
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
Zeitfenster: On 4 and 7 days
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
Zeitfenster: 14 days
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
Zeitfenster: 14 days
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
Zeitfenster: 14 days
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
Zeitfenster: 14 days
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
Zeitfenster: 14 days
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
Zeitfenster: 14 days
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)
Zeitfenster: 14 days
Blood Pressure measured in mm Hg. Based on medical records.
14 days
Changes in vital signs (Heart Rate)
Zeitfenster: 14 days
Pulse Rate measured in beats per minute. Based on medical records.
14 days
Changes in vital signs (Breathing Rate)
Zeitfenster: 14 days
Respiratory Rate measured in breaths per minute. Based on medical records.
14 days

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Materia Medica Holding

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

9. Dezember 2025

Primärer Abschluss (Geschätzt)

31. Dezember 2028

Studienabschluss (Geschätzt)

31. Dezember 2028

Studienanmeldedaten

Zuerst eingereicht

10. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

10. Juni 2026

Zuerst gepostet (Tatsächlich)

16. Juni 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

16. Juni 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

10. Juni 2026

Zuletzt verifiziert

1. März 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • MMH-407-012

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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