Study of the Efficacy and Safety of Broncho-munal®, Capsules, 7 mg for the Treatment of Acute Uncomplicated Respiratory Tract Infections

• Status: Not yet recruiting
• Trial end date: 2022-12-31
• Target enrollment: 0
• Participant gender: All

Summary

The study will evaluate the efficacy and safety of Broncho-munal®, capsules, 7 mg (Sandoz dd, Slovenia) versus Placebo in the treatment of patients with acute uncomplicated respiratory tract infections.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sandoz

Criteria

Inclusion Criteria:

• Patient signing and dating of the Patient Information Sheet Informed Consent Form.

• Men and women between the ages of 18 and 60 inclusive at the time of signing the Patient Information Sheet Informed Consent Form.

• Symptoms of acute uncomplicated respiratory tract infection of mild to moderate severity:

• The presence of two or more symptoms of moderate severity or three or more symptoms of mild severity according to the WURSS-21 questionnaire

• The presence of two or more symptoms of moderate severity or three or more symptoms of mild severity according to the CCQ questionnaire

• Body temperature ≥ 37.50 ° C and ≤ 40.0 ° C since the onset of the disease.

• Duration of disease symptoms less than 36 hours prior to randomization.

• The patient's consent to use reliable contraceptive methods throughout the study and for 3 weeks after its completion. The following may take part in the study:

women who have a negative pregnancy test and are using the following contraception: barrier method (condom or occlusion cap (diaphragm or cervical / vaulted cap)) or dual barrier method of contraception (condom or occlusive cap (diaphragm or cervical / sperm cap (cid) plus foam / gel / film / cream / suppository)). The study may also include women who are unable to bear children.

(history: hysterectomy, tubal ligation, infertility, menopause for more than 1 year).

Or men with safe reproductive function using barrier contraception, as well as men with infertility or previous vasectomy history.

Exclusion Criteria:

• Aggravated history of allergies, including food allergies

• Intolerance to drugs, incl. hypersensitivity or idiosyncrasy to Broncho-munal® or its excipients and to any other product from the concomitant / standard treatment

• A positive result of the analysis performed by the PCR method for the presence of SARS-CoV-2 RNA at the screening stage.

• Positive result of the analysis performed by Rapid Influenza Diagnostic Test for the presence of the influenza virus at the screening stage.

• Clinically confirmed of the presence of a new coronavirus infection COVID-19 in accordance with the regulatory acts of the Ministry of Health of the Russian Federation for the prevention, diagnosis and treatment of a new coronavirus infection (COVID-19), (the version is current at the time of inclusion of patients).

• Any vaccination less than 30 days before screening.

• The presence of any symptom of a severe course of the disease (fever of 40 ° C and higher, pulse - more than 120 beats / min, SBP - less than 90 mm Hg, muffled heart sounds, NPV - more than 28 per minute, the presence of complications, impairment of consciousness, seizures).

• Other infectious diseases less than 14 days before the screening visit, including those requiring local and / or systemic antibiotic therapy (cystitis, pyelonephritis, endocarditis, etc.)

• Chronic lung diseases (such as cystic fibrosis, pulmonary emphysema, tracheobchonchial dyskinesia, chronic obstructive pulmonary disease (COPD), bronchiectasis, etc.) in the acute stage.

• Bronchial asthma and chronic bronchitis in history.

• Pulmonary tuberculosis (active or inactive form).

• The use of drugs with immunomodulatory (including Broncho-munal) and / or immunostimulating and / or immunosuppressive effects, less than 1 month before screening.

• The need to use drugs from the list of prohibited therapy.

• Peptic ulcer of the stomach and duodenum or other erosive and ulcerative lesions of the gastrointestinal tract in the acute stage.

• Syndrome of malabsorption or other clinically significant disease of the gastrointestinal tract (uncorrected vomiting, diarrhea, ulcerative colitis, and others).

• Deficiency of the enzyme glucose-6-phosphate dehydrogenase.

• Dehydration, hypovolemia, anorexia, bulimia and cachexia (insufficient supply of glutathione in the liver) according to the anamnesis at the time of screening.

• Autoimmune diseases, according to anamnesis (systemic lupus erythematosus, rheumatoid arthritis, etc.).

• Uncontrolled diabetes mellitus.

• Syndrome of renal or hepatic insufficiency, confirmed by physical examination data.

• Positive result of any of the following tests: blood test for Hep. B, Hep.C, HIV and/or syphillis.

• Chronic heart failure III - IV functional class according to the functional classification of the New York Heart Association (NYHA), including unstable progressive angina pectoris IV functional class, uncontrolled arterial hypertension, severe arterial hypotension.

• A history of malignant neoplasms.

• Alcohol or drug addiction, history of mental illness.

• Smoking more than 20 cigarettes a day.

• Severe, decompensated or unstable somatic diseases (any diseases or conditions that threaten the patient's life or worsen the patient's prognosis, as well as make it impossible for him to participate in a clinical trial).

• Major surgery, 3 months before screening (associated with a risk to the patient's life).

• Patient's unwillingness or inability to comply with Protocol procedures (in the opinion of the investigator).

• Taking other medications that, in the Investigator's opinion, may affect the course and results of the clinical trial.

• Pregnancy or breastfeeding period.

• Participation in other clinical trials at the screening visit or for 30 days before the screening visit.

• Other conditions that, in the Investigator's opinion prevent the patient from being included in the research.