2023-507370-41-00已完成4 期
Randomized, controlled, open-label, multi-center trial to compare the efficacy and safety of three herbal medicinal products in the treatment of acute bronchitis
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 12
- 主要终点
- Change of BSS between visit V1 (baseline) and visit V6 (7 days of treatment)
研究概览
简要总结
Assessment of non-inferiority of Test vs. Reference 1 with regard to the change in Bronchitis Severity Score (BSS) in patients with acute bronchitis after 7 days of treatment Assessment of non-inferiority of Test vs. Reference 2 with regard to the change in Bronchitis Severity Score (BSS) in patients with acute bronchitis after 7 days of treatment
研究设计
- 分配方式
- Randomized
- 主要目的
- Period No. I
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Acute bronchitis with symptoms that have been present for 48-72 hours prior to treatment
- •Male or female patients of any ethnic origin
- •Age: 18 – 75 years, inclusive
- •Patients who are able to understand and are willing to follow the study rules
- •Patients who have given their written informed consent to participate in the study
- •With the exception of the existing bronchitis, good state of health as judged by the investigator based on medical history and physical examination
- •CS score of at least 50 mm on the 100 mm VAS at visit V1
- •BSS of at least 10 points at visit V1
- •VCD score of at least 2 points at visit V1
排除标准
- •Allergic bronchial asthma, bronchial hyperresponsiveness, chronic bronchitis, other chronic or hereditary lung diseases
- •Any other phytopharmaceutical medication (e.g. pelargonium extracts or other ivy preparations) or homeopathic medicines for the common cold within the last 7 days before visit V1
- •Patients who have been strictly forbidden by their doctor to take minimal amounts of alcohol (e.g., after a detoxification cure)
- •Medication, drug or alcohol abuse as judged by the investigator
- •Pregnant or lactating women
- •Body temperature >38.3°C
- •Women of childbearing potential who do not agree to apply highly effective contraceptive methods (highly effective contraceptive methods are defined in chapter 13.2.1 of the clinical trial protocol; Definition of women of childbearing potential and post-menopausal women is given in chapter 4.2.8 of the clinical trial protocol.)
- •Patients suffering from a significant condition, defined as a condition which, at the discretion of the investigator, either exposes the patient to a risk by participating in the study, or which affects the results of the study or the ability of the patient to participate in the study. This criterion includes patients with a history of gastrointestinal bleeding, significant cardiovascular, hepatic or renal disease.
- •Patients directly or indirectly involved in the conduct of this study, including employees of the sponsor, CRO and their relatives
- •History of hypersensitivity to any of the constituents of the IMPs
- •History of drug hypersensitivity, asthma, urticaria or other severe allergic diathesis or current hay fever
- •History of chronic gastritis or peptic ulcer
- •Any gastrointestinal complaints within the last 7 days before visit V1
- •Patients with known hereditary fructose-intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency
- •Participation in a clinical trial within the last 30 days prior to the treatment phase of this study
- •Simultaneous participation in another clinical trial with active ingredients
- •Treatment with corticoids, beta-2 agonists (e.g., salbutamol, fenoterol), expectorants, theophylline, antitussives, anaesthetics, acetylsalicylic acid (e.g., Aspirin with daily dose > 100mg) or other non-steroidal anti-inflammatory drugs, leukotriene inhibitors, ACE inhibitors, antiviral drugs or antibiotics, antihistamines, immunosuppressants, isoprenaline, atropine, sodium cromoglycate within the last 7 days before visit V1
结局指标
主要结局
Change of BSS between visit V1 (baseline) and visit V6 (7 days of treatment)
Change of BSS between visit V1 (baseline) and visit V6 (7 days of treatment)
次要结局
- Change of BSS between visit V1 (baseline) and each post-baseline visit V2, V3, V4, V5, V7, and V8 as well as baseline adjusted AUC
- BSS at each post-baseline visits V2 to V8 and change of BSS between visit V1 (baseline) and post-baseline visits V2, V3, V4, V5, V7, and V8, and related AUCs
- CS assessed on VAS between visit V1 (baseline) and post-baseline visits (Area under the curve (AUC) generated with VAS values between visit V1 (baseline) and post-baseline visits V2, V3, V4, V5, V6, V7, and V8 as well as baseline adjusted AUC)
- CS assessed on VAS at each post-baseline visit and change of CS-VAS between visit V1 (baseline) and post-baseline visits, and related AUCs.
- Change in CS assessed by VCD score between visit V1 (baseline) and each post-baseline visit V2, V3, V4, V5, V6, V7, and V8
- Global efficacy (scores of a 5-point Likert scale by patient and investigator) at post-baseline visits V6, V7 and V8
研究者
Clinical Research Manager
Scientific
Engelhard Arzneimittel GmbH & Co. KG
研究点 (12)
Loading locations...
相似试验
已完成
4 期
Evaluation of the Efficacy and Safety of Adjunctive Zonisamide vs Replacement With Zonisamide of the Last Added Antiepileptic DrugPartial SeizuresNCT01630057Eisai Inc.200
已完成
2 期
Phase 2 Study to Evaluate the Preliminary Performance of the C13-URA Breath Test Kit in Dyspeptic SubjectsDyspeptic SubjectsNCT01677338Otsuka Pharmaceutical Co., Ltd.20
暂停
不适用
A comparison of once daily insulin detemir given pre-breakfast or bedtime, according to need, with bedtime insulin glargine in people with type 2 diabetes characterized by an asymmetric insulin requirement across the day and night.Type 2 diabetes.NL-OMON25809Dr. J.H. de VriesAcademic Medical Center - AmsterdamandProf. Philip HomeUniversity of Newcastle upon Tyne, UK175
招募中
不适用
Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-TMetastatic Castration-Resistant Prostate Cancer (mCRPC)NCT06134232Dendreon400
已完成
2/3 期
Clinical Study on Lupin’s Ayurvedic Nasal Spray in COVID-19 patients and household contactsCTRI/2021/08/036089Lupin Ltd150