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

NCT ID: NCT05588804

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 556 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-07
• Study Completion Date: 2022-12-18

Brief 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.

Detailed Description

Patients who meet the inclusion criteria and do not meet the exclusion criteria will be randomized into 2 groups in a 1: 1 ratio.

Group 1 (n = 278) will receive the study drug Broncho-munal®, capsules, 7 mg (Sandoz dd, Slovenia),

Group 2 (n = 278) will receive a placebo

Conditions

Acute Uncomplicated Respiratory Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group 1: Broncho-munal®

Participants will receive the study drug Broncho-munal®, capsules, 7 mg (Sandoz dd, Slovenia), 1 capsule per day in the morning on an empty stomach, 30 minutes before meals, for 10 consecutive days

Group Type: EXPERIMENTAL

Broncho-munal®

Intervention Type: DRUG

1 capsule daily in the morning on an empty stomach, 30 minutes before meals, for 10 consecutive days

Group 2: Placebo

Participants will receive a placebo, 1 capsule per day in the morning on an empty stomach, 30 minutes before meals, for 10 consecutive days

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

1 capsule daily in the morning on an empty stomach, 30 minutes before meals, for 10 consecutive days

Interventions

Broncho-munal®

1 capsule daily in the morning on an empty stomach, 30 minutes before meals, for 10 consecutive days

Intervention Type: DRUG

Placebo

1 capsule daily in the morning on an empty stomach, 30 minutes before meals, for 10 consecutive days

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sandoz

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sandoz

Role: STUDY_DIRECTOR

Sandoz

Locations

Sandoz Investigative Site

Moscow, , Russia

Sandoz Investigative Site

Nizhny Novgorod, , Russia

Sandoz Investigative Site

Saint Petersburg, , Russia

Sandoz Investigative Site

Saint Petersburg, , Russia

Sandoz Investigative Site

Saint Petersburg, , Russia

Sandoz Investigative Site

Saint Petersburg, , Russia

Sandoz Investigative Site

Saint Petersburg, , Russia

Sandoz Investigative Site

Saint Petersburg, , Russia

Sandoz Investigative Site

Saint Petersburg, , Russia

Sandoz Investigative Site

Saint Petersburg, , Russia

Sandoz Investigative Site

Saint Petersburg, , Russia

Sandoz Investigative Site

Saint Petersburg, , Russia

Sandoz Investigative Site

Saint Petersburg, , Russia

Countries

Russia

Other Identifiers

CT_003_BRO_CAP/SAN-0632

Identifier Type: -

Identifier Source: org_study_id