NCT05588804已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sandoz
- 入组人数
- 556
- 试验地点
- 1
- 主要终点
- AUC value of the change in the symptom severity according to the WURSS-21 questionnaire
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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
干预措施: Broncho-munal® (Drug)
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
干预措施: Placebo (Drug)
结局指标
主要结局
AUC value of the change in the symptom severity according to the WURSS-21 questionnaire
时间窗: 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.
次要结局
- 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)
- Total score on the CCQ scale(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(by 3, 5, 7 and 10 days after the start of therapy)
- Number of patients with symptoms of varying severity on the CCQ scale(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(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(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(by 3, 5, 7 and 10 days after the start of therapy)
- Number of patients with the need for systemic antibiotic therapy(by 3, 5, 7 and 10 days after the start of therapy)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
1 期
Safety, Tolerability and Efficacy of MK0773 in Healthy Postmenopausal Women (0773-003)OsteoporosisNCT01011725Merck Sharp & Dohme LLC67
终止
1 期
Safety, Tolerability, Pharmacokinetics, and Preliminary Pharmacodynamics of QBW251 in Healthy Subjects and Cystic Fibrosis PatientsCystic FibrosisNCT02190604Novartis Pharmaceuticals153
已完成
1 期
Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Immunogenicity of QGE031 in Japanese Atopic Male SubjectsAllergyNCT01596712Novartis Pharmaceuticals209
已完成
1 期
A Randomized, Double-blind, Placebo-controlled Study to Assess Safety, Tolerability, Pharmacokinetics, Immunogenicity, and Pharmacodynamic Response of Repeated Intravenous Infusions of BAN2401 in Subjects With Mild Cognitive Impairment Due to Alzheimer's Disease and Mild Alzheimer's DiseaseAlzheimer's DiseaseNCT02094729Eisai Co., Ltd.26
已完成
1 期
Safety, Pharmacodynamic and Pharmacokinetic Effects of QAX576 in Healthy Volunteers.HealthyNCT00417196Novartis32