A Phase 3 interventional study of Broncho-munal® and Placebo in Acute Uncomplicated Respiratory Tract Infections, sponsored by Sandoz. Completed at 13 sites in Russian Federation. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-08-04.
Sponsored by Sandoz · Phase 3, Interventional, and Treatment
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.
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
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 556 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Sandoz is the lead sponsor of 136 studies on the registry; none are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
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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:
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®
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
1 capsule daily in the morning on an empty stomach, 30 minutes before meals, for 10 consecutive days
1 capsule daily in the morning on an empty stomach, 30 minutes before meals, for 10 consecutive days
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.
Time frame: by 3, 5, 7 and 10 days after the start of therapy
Change in symptom severity index according to the WURSS-21 questionnaire
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.
Time frame: by 3, 5, 7 and 10 days after the start of therapy
Change in symptom severity index on the CCQ scale
General symptoms (fever, chills, muscle pain), nasal symptoms (nasal discharge, sneezing, watery eyes), throat (sore throat) and chest symptoms (cough, chest pain) are assessed in points from 0 to 3. Assessment will be conducted by the Investigating Physician during visits to the Research Center. A ´probable' viral infection is where there are moderate symptoms noted in at least 2 of the above 4 categories or mild symptoms noted in 3 or more categories. A ´possible´ viral infection is where mild symptoms are noted in one category plus a cough. Scoring: none=0, mild=1, moderate=2 and severe=3. Total score equals the sum of all scores.
Time frame: 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
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.
Time frame: by 3, 5, 7 and 10 days after the start of therapy
Time (in days) until symptoms disappear on the CCQ scale
General symptoms (fever, chills, muscle pain), nasal symptoms (nasal discharge, sneezing, watery eyes), throat (sore throat) and chest symptoms (cough, chest pain) are assessed in points from 0 to 3. Assessment will be conducted by the Investigating Physician during visits to the Research Center. A ´probable' viral infection is where there are moderate symptoms noted in at least 2 of the above 4 categories or mild symptoms noted in 3 or more categories. A ´possible´ viral infection is where mild symptoms are noted in one category plus a cough. Scoring: none=0, mild=1, moderate=2 and severe=3. Total score equals the sum of all scores.
Time frame: by 3, 5, 7 and 10 days after the start of therapy
Total score on the WURSS-21 scale
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.
Time frame: by 3, 5, 7 and 10 days after the start of therapy
Total score on the CCQ scale
General symptoms (fever, chills, muscle pain), nasal symptoms (nasal discharge, sneezing, watery eyes), throat (sore throat) and chest symptoms (cough, chest pain) are assessed in points from 0 to 3. Assessment will be conducted by the Investigating Physician during visits to the Research Center. A ´probable' viral infection is where there are moderate symptoms noted in at least 2 of the above 4 categories or mild symptoms noted in 3 or more categories. A ´possible´ viral infection is where mild symptoms are noted in one category plus a cough. Scoring: none=0, mild=1, moderate=2 and severe=3. Total score equals the sum of all scores.
Time frame: by 3, 5, 7 and 10 days after the start of therapy
Number of patients with symptoms and daily activity of varying severity on the WURSS-21 scale
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.
Time frame: by 3, 5, 7 and 10 days after the start of therapy
Number of patients with symptoms of varying severity on the CCQ scale
General symptoms (fever, chills, muscle pain), nasal symptoms (nasal discharge, sneezing, watery eyes), throat (sore throat) and chest symptoms (cough, chest pain) are assessed in points from 0 to 3. Assessment will be conducted by the Investigating Physician during visits to the Research Center. A ´probable' viral infection is where there are moderate symptoms noted in at least 2 of the above 4 categories or mild symptoms noted in 3 or more categories. A ´possible´ viral infection is where mild symptoms are noted in one category plus a cough. Scoring: none=0, mild=1, moderate=2 and severe=3. Total score equals the sum of all scores.
Time frame: by 3, 5, 7 and 10 days after the start of therapy
Number of patients with complete disappearance of symptoms according to the WURSS-21 questionnaire for each day of therapy
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.
Time frame: by 3, 5, 7 and 10 days after the start of therapy
Number of patients with complete disappearance of symptoms on the CCQ scale for each day of therapy
General symptoms (fever, chills, muscle pain), nasal symptoms (nasal discharge, sneezing, watery eyes), throat (sore throat) and chest symptoms (cough, chest pain) are assessed in points from 0 to 3. Assessment will be conducted by the Investigating Physician during visits to the Research Center. A ´probable' viral infection is where there are moderate symptoms noted in at least 2 of the above 4 categories or mild symptoms noted in 3 or more categories. A ´possible´ viral infection is where mild symptoms are noted in one category plus a cough. Scoring: none=0, mild=1, moderate=2 and severe=3. Total score equals the sum of all scores.
Time frame: by 3, 5, 7 and 10 days after the start of therapy
Number of patients with body temperature <37°C from the moment the temperature drops to completion of therapy for each day of therapy
Number of patients with body temperature \<37°C from the moment the temperature drops to completion of therapy for each day of therapy will be reported.
Time frame: by 3, 5, 7 and 10 days after the start of therapy
Number of patients with the need for systemic antibiotic therapy
Number of patients requiring local and / or systemic antibiotic therapy (cystitis, pyelonephritis, endocarditis, etc.) will be reported.
Time frame: by 3, 5, 7 and 10 days after the start of therapy
Plan to share: Yes — Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
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