Clinical trial NCT05588804: Study of the Efficacy and Safety of Broncho-munal®, Capsules, 7 mg for the Treatment of Acute Uncomplicated Respiratory Tract Infections
Official title: A Randomized Double-blind Placebo-controlled Comparative Multicenter Study of the Efficacy and Safety of Broncho-munal®, Capsules, 7 mg (Sandoz dd, Slovenia) in the Treatment of Patients With Acute Uncomplicated Respiratory Tract Infections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Uncomplicated Respiratory Tract Infections
Lead sponsor: Sandoz
Sponsor class: INDUSTRY
First posted: 2022-10-20
Enrollment: 556
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Primary outcomes:
measure: AUC value of the change in the symptom severity according to the WURSS-21 questionnaire
timeFrame: by 3, 5, 7 and 10 days after the start of therapy
Secondary outcomes:
measure: Change in symptom severity index according to the WURSS-21 questionnaire
timeFrame: by 3, 5, 7 and 10 days after the start of therapy
measure: Change in symptom severity index on the CCQ scale
timeFrame: by 3, 5, 7 and 10 days after the start of therapy
measure: Time (in days) until the symptoms of the disease disappear according to the WURSS-21 scale
timeFrame: by 3, 5, 7 and 10 days after the start of therapy
measure: Time (in days) until symptoms disappear on the CCQ scale
timeFrame: by 3, 5, 7 and 10 days after the start of therapy
measure: Total score on the WURSS-21 scale
timeFrame: by 3, 5, 7 and 10 days after the start of therapy
measure: Total score on the CCQ scale
timeFrame: by 3, 5, 7 and 10 days after the start of therapy
measure: Number of patients with symptoms and daily activity of varying severity on the WURSS-21 scale
timeFrame: by 3, 5, 7 and 10 days after the start of therapy
measure: Number of patients with symptoms of varying severity on the CCQ scale
timeFrame: by 3, 5, 7 and 10 days after the start of therapy
measure: Number of patients with complete disappearance of symptoms according to the WURSS-21 questionnaire for each day of therapy
timeFrame: by 3, 5, 7 and 10 days after the start of therapy
measure: Number of patients with complete disappearance of symptoms on the CCQ scale for each day of therapy
timeFrame: by 3, 5, 7 and 10 days after the start of therapy
measure: Number of patients with body temperature <37°C from the moment the temperature drops to completion of therapy for each day of therapy
timeFrame: by 3, 5, 7 and 10 days after the start of therapy
measure: Number of patients with the need for systemic antibiotic therapy
timeFrame: by 3, 5, 7 and 10 days after the start of therapy
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Sandoz Investigative Site
city: Nizhniy Novgorod
country: Russian Federation
facility: Sandoz Investigative Site
city: Saint-Petersburg
country: Russian Federation
facility: Sandoz Investigative Site
city: Saint-Petersburg
country: Russian Federation
facility: Sandoz Investigative Site
city: Saint-Petersburg
country: Russian Federation
facility: Sandoz Investigative Site
city: Saint-Petersburg
country: Russian Federation
facility: Sandoz Investigative Site
city: Saint-Petersburg
country: Russian Federation
facility: Sandoz Investigative Site
city: Saint-Petersburg
country: Russian Federation
facility: Sandoz Investigative Site
city: Saint-Petersburg
country: Russian Federation
facility: Sandoz Investigative Site
city: Saint-Petersburg
country: Russian Federation
facility: Sandoz Investigative Site
city: Saint-Petersburg
country: Russian Federation
facility: Sandoz Investigative Site
city: Saint-Petersburg
country: Russian Federation
facility: Sandoz Investigative Site
city: Saint-Petersburg
country: Russian Federation
facility: Sandoz Investigative Site
Study officials:
affiliation: Sandoz
name: Sandoz
role: STUDY_DIRECTOR
References: