EUCTR2010-022819-19-DE进行中（未招募）不适用
Efficacy, safety and tolerability of two weeks treatment with SIA capsules in acute bronchitis - A multi-centre, randomised, placebo-controlled, double-blind, parallel-group trial - - SIA in acute bronchitis
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.A signed and dated written informed consent and data protection declaration
- •2.Male and female outpatients
- •3.Race: Caucasian
- •4.Age: ³ 18 years
- •5.Weight: Broca Index 0.75 – 1.30
- •6.Clinical diagnosis of acute bronchitis as characterized by:
- •-= 10 coughing fits during the last day prior to Visit 1 (according to patient´s estimate)
- •-Baseline Bronchitis Severity Score (BSS) = 5 points (of maximum 20 points)
- •-Onset of first symptoms (bronchial mucus production with impaired ability to cough up) within two days before treatment initiation.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Prohibited previous and concomitant medication (see below)
- •2.Medical history or presence of the following respiratory diseases:
- •-Recent upper respiratory tract infection (< 4 weeks)
- •-Chronic bronchitis or acute exacerbations of chronic bronchitis
- •-Chronic obstructive pulmonary disease (COPD) or acute exacerbation of COPD
- •-Bronchiectasis
- •-Bronchial asthma
- •-Suspected Pneumonia
- •-Mucoviscidosis
- •-Lung cancer (except other malignancies, if they are in remission ³ 5 years)
- •3.Concomitant bacterial infection
- •4.Body temperature > 39.5°C rectal or >39.0°C axillary or otic
- •5.Tobacco smoking > 1 pack of cigarettes per day
- •6.Known hypersensitivity to one or more of the active and / or inactive ingredients of the product (e.g. eucalyptus oil, sweet orange oil, myrtle oil, lemon oil or cineole, cineole [the main constituent of eucalyptus oil])
- •7.Inflammatory gastrointestinal or hepatic disease or inflammation of the gallbladder or bile duct
- •8.History or presence of clinically relevant cardiovascular, renal, metabolic, haematological, dermatologic, neurological, psychiatric, systemic or infectious disease
- •9.Any other comorbidity is only allowed if it does not interfere with the eligibility criteria and the evaluation of the study endpoints
- •10.Pregnant or breastfeeding women
- •11.Women of childbearing potential without highly effective contraception (failure rate less than 1%)
- •12.Current participation in a research study involving an investigational product or within the last 6 weeks
- •13.Previous participation in this clinical study
- •14.Known to be, or suspected of being unable to comply with the study protocol (e.g. no permanent address, history of or (and) known drug abuse, known to be non-compliant or presenting an unstable psychiatric history)
- •15.Legal incapacity and / or other circumstances rendering the patient unable to understand the nature, scope and possible impact of the study
- •16.Patients in custody by juridical or official order
- •17.Evidence of an uncooperative attitude (non-compliance)
- •18.Patients who have difficulties in understanding the language in which the patient information is given
- •19.Patients who do not agree to the transmission of their pseudonymous data within the liability of documentation and notification
- •Not permitted within 4 weeks before Visit 1
- •·Antibiotics
- •·Systemic or inhalation glucocorticosteroids
- •·Start of angiotensin converting enzymes (ACE) inhibitors
- •Not permitted within 2 calendar days before Visit 1:
- •·Secretolytics, mucolytics, and antitussive drugs (e.g. codeine or other morphine derivatives)
- •Not permitted from Visit 1 to Visit 4:
- •·Any inhalation and / or physical therapy of acute bronchitis
- •·Expectorants / mucoactive drugs
- •·Antitussive drugs (e.g. codeine or other morphine derivatives)
- •·Analgesics (except paracetamol)
- •·Sedatives / hypnotics or sedating antihistamines
- •·Systemic antibiotics
- •·Systemic or inhalation corticosteroids
- •·Medications causing cough:
- •-ACE inhibitors
- •-Angiotensin II receptor antagonists (e.g. valsartan, losartan)
- •-Antiarrhythmic (e.g. amiodaron)
- •-Inhaled bronchodilators, such as beta 2-agonists (e.g. salmeterol) and inhaled anticholinergics (e.g. ipratropium bromide)
- •-Inhaled corticosteroids (e.g. budesonide)
- •-Inhaled chromoglycate
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