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

NCT05588804 | Completed Phase 3

• 1 other identifier: CT_003_BRO_CAP/SAN-0632
• Study Type: interventional
• Target: 556
• Locations: 1 country
• Sites: 13

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.

Conditions

Acute Uncomplicated Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• AUC value of the change in the symptom severity according to the WURSS-21 questionnaire

  Dynamics of symptoms severity according to the WURSS-21 is assessed using the Area under the curve (AUC) for the score for 3, 5, 7 and 10 days of the treatment. WURSS-21 consists of 21 items (2 questions and 2 domains. Symptoms domain consists of 10 items: Runny nose, Plugged nose, Sneezing, Sore throat, Scratchy throat, Cough, Hoarseness, Head congestion, Chest congestion, Feeling tired. Ability domain consists of 9 items: Think clearly, Sleep well, Breathe easily, Walk, climb stairs, exercise, Accomplish daily activities, Work outside the home, Work inside the home, Interact with others, Live your personal life. The first 20 items are scored according to the 8-point scale (from 0 to 7). The last item is scored according to the 7-point scale: (from 0 to 6). Higher scores mean a worse outcome.

  by 3, 5, 7 and 10 days after the start of therapy

Secondary Outcomes (12)

• Change in symptom severity index according to the WURSS-21 questionnaire

  by 3, 5, 7 and 10 days after the start of therapy

• Change in symptom severity index on the CCQ scale

  by 3, 5, 7 and 10 days after the start of therapy

• Time (in days) until the symptoms of the disease disappear according to the WURSS-21 scale

  by 3, 5, 7 and 10 days after the start of therapy

• Time (in days) until symptoms disappear on the CCQ scale

  by 3, 5, 7 and 10 days after the start of therapy

• Total score on the WURSS-21 scale

  by 3, 5, 7 and 10 days after the start of therapy

Study Arms (2)

Group 1: Broncho-munal®

EXPERIMENTAL

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

Drug: Broncho-munal®

Group 2: Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Broncho-munal® DRUG

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

Group 1: Broncho-munal®

Placebo DRUG

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

Group 2: Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Sandoz: lead

Study Sites (13)

Sandoz Investigative Site

Moscow, 117321, Russia

Location

Sandoz Investigative Site

Nizhny Novgorod, 603140, Russia

Location

Sandoz Investigative Site

Saint Petersburg, 194156, Russia

Location

Sandoz Investigative Site

Saint Petersburg, 194354, Russia

Location

Sandoz Investigative Site

Saint Petersburg, 194358, Russia

Location

Sandoz Investigative Site

Saint Petersburg, 195197, Russia

Location

Sandoz Investigative Site

Saint Petersburg, 196143, Russia

Location

Sandoz Investigative Site

Saint Petersburg, 197136, Russia

Location

Sandoz Investigative Site

Saint Petersburg, 197198, Russia

Location

Sandoz Investigative Site

Saint Petersburg, 197342, Russia

Location

Sandoz Investigative Site

Saint Petersburg, 197706, Russia

Location

Sandoz Investigative Site

Saint Petersburg, 198328, Russia

Location

Sandoz Investigative Site

Saint Petersburg, 199226, Russia

Location

Study Officials

• Sandoz

  Sandoz

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2022
• First Posted: October 20, 2022
• Study Start: November 7, 2022
• Primary Completion: December 18, 2022
• Study Completion: December 18, 2022
• Last Updated: August 4, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will share

Locations

RU (13)