Acute Uncomplicated Respiratory Tract InfectionsPhase 3NCT05588804
Study of the Efficacy and Safety of Broncho-munal®, Capsules, 7 mg for the Treatment of Acute Uncomplicated Respiratory Tract Infections
A Phase 3 study testing Broncho-munal® in people with Acute Uncomplicated Respiratory Tract Infections, run by Sandoz at 13 sites in Russia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Uncomplicated Respiratory Tract Infections
- What is being tested?
- Broncho-munal®
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 556 participants
- Where
- 13 sitesRussia
- Study dates
- 7 Nov 2022to 18 Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
13 sites in 1 country.
13 sites in 1 country
Russia13 sites
Sandoz Investigative Site
Moscow, 117321
Sandoz Investigative Site
Nizhny Novgorod, 603140
Sandoz Investigative Site
Saint Petersburg, 194156
Sandoz Investigative Site
Saint Petersburg, 194354
Sandoz Investigative Site
Saint Petersburg, 194358
Sandoz Investigative Site
Saint Petersburg, 195197
Sandoz Investigative Site
Saint Petersburg, 196143
Sandoz Investigative Site
Saint Petersburg, 197136
Sandoz Investigative Site
Saint Petersburg, 197198
Sandoz Investigative Site
Saint Petersburg, 197342
Sandoz Investigative Site
Saint Petersburg, 197706
Sandoz Investigative Site
Saint Petersburg, 198328
Sandoz Investigative Site
Saint Petersburg, 199226
About this study
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
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.
Read the 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
- Being tested
- Broncho-munal®, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Broncho-munal®Drug
1 capsule daily in the morning on an empty stomach, 30 minutes before meals, for 10 consecutive days
PlaceboDrug
1 capsule daily in the morning on an empty stomach, 30 minutes before meals, for 10 consecutive days
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: by 3, 5, 7 and 10 days after the start of therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start7 Nov 2022
- Primary completion18 Dec 2022
- Study completion18 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Uncomplicated Respiratory Tract InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 556 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sandoz
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sandoz, Study director, Sandoz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05588804
- Sponsor's protocol ID
- CT_003_BRO_CAP/SAN-0632
- Status last verified
- Aug 2023
- First submitted
- 17 Oct 2022
- Last updated
- 4 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05588804
- Acronym / sponsor ID
- CT_003_BRO_CAP/SAN-0632
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 556 participants (actual)
- Lead sponsor
- SandozIndustry (pharma, biotech, devices)
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 18 Dec 2022 (actual)
- Study completion
- 18 Dec 2022 (actual)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1: Broncho-munal® | Experimental | Drug: 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 2: Placebo | Placebo comparator | Drug: PlaceboParticipants will receive a placebo, 1 capsule per day in the morning on an empty stomach, 30 minutes before meals, for 10 consecutive days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (32 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Broncho-munal®1 capsule daily in the morning on an empty stomach, 30 minutes before meals, for 10 consecutive days | Drug | Group 1: Broncho-munal® |
| Placebo1 capsule daily in the morning on an empty stomach, 30 minutes before meals, for 10 consecutive days | Drug | Group 2: Placebo |
Primary outcome
AUC value of the change in the symptom severity according to the WURSS-21 questionnaire
Time frame: by 3, 5, 7 and 10 days after the start of therapy
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.
12 secondary outcomes
Change in symptom severity index according to the WURSS-21 questionnaire
Time frame: by 3, 5, 7 and 10 days after the start of therapy
Change in symptom severity index on the CCQ scale
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
Time frame: by 3, 5, 7 and 10 days after the start of therapy
Time (in days) until symptoms disappear on the CCQ scale
Time frame: by 3, 5, 7 and 10 days after the start of therapy
Total score on the WURSS-21 scale
Time frame: by 3, 5, 7 and 10 days after the start of therapy
Total score on the CCQ scale
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
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
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
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
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
Time frame: by 3, 5, 7 and 10 days after the start of therapy
Number of patients with the need for systemic antibiotic therapy
Time frame: by 3, 5, 7 and 10 days after the start of therapy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2023.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sandoz study director
Sandoz
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Broncho-munal® in people with Acute Uncomplicated Respiratory Tract Infections, run by Sandoz at 13 sites in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUC value of the change in the symptom severity according to the WURSS-21 questionnaire (time frame: by 3, 5, 7 and 10 days after the start of therapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2023.