Investigation of the efficacy and safety of ANGOCIN® Anti-Infekt N versus placebo in adult patients with acute bronchitis.
- Conditions
- acute bronchitisMedDRA version: 20.1Level: LLTClassification code 10006452Term: Bronchitis acuteSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
- Registration Number
- EUCTR2018-001395-37-DE
- Lead Sponsor
- Repha GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 380
1. signed informed consent
2. male and female outpatients aged =18 und =75 Jahre
3. diagnosis of acute (or recurrend acute) bronchitis:
- characterized by the main symptoms with an BSSinv Score = 5
- symptoms occured = 48 h before study enrolment
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 300
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 80
a) Diseases
1. Chronic Bronchitis (i.e. all forms and causes of persistent chronic bronchitis)
2. Patients with severe respiratory infections, requiring treatment with antibiotics
3. Diagnosed Asthmatics or patients with diagnosed allergic bronchial Asthma (severity in adults: ligth to severe according to S2k guidance for asthmatics diagnosis), diagnosed bronchietktase, and diagnosed chronic obstructive pulmonary disease (COPD, GOLD I-IV)
4. Cystic fibrosis
5. Known hypersensitivity to study medication / placebo or respective excipients
6. Any contraindications to the study medication
7. known immune deficient patients, known progressive autoimmune diseases
8. Signs or symptoms of fulminant bacterial Bronchitis (fever > 38.5°C)
9. Diagnosed severe heart diseases NYHA class >/= 2(e. g. myocardial infarction, coronary heart disease)
10. Diagnosed severe diseases of the liver (e. g. fatty liver, liver cirrhosis)
11. Diagnosed severe diseases of the kidney (serum creatinine > 1.4 mg/dL)
12. Severe somatopathic, neurological and / or psychiatric diseases making it difficult for the Patient to decide to consent to Trial participation
13.Patients with malignant growth processes or cancer treatment within the last five years (head / neck Treatments) and / or within the last 2
years (other body regions) prior to study inclusion with further hazardous potential
14. Any condition which might interfere with study objectives or that would limit the patients ability to complete the study as judged by the
investigator
15. Exisiting habits of alcohol or drug abuse
b) Medication
1. Treatment with immunosuppressive medication 8 weeks prior to screening
2. Treatment with systemic or inhalative antibiotics or nasal or systemic / inhalative corticosteroids within the last 30 days prior to study inclusion
3. Systemic or inhalative antiviral treatment such as aciclovir; zanamivir, or oseltamivir within 30 days prior to visit 1.
4. Treatment with registered alternative medicinal preparations for treatment of common cold like symptoms or with immunomodulating properties,
within the last 7 days prior to study inclusion
5. Treatment with bronchodilatators within the last 7 days prior to study enrolment
6. Treament with expectorants or antitussives within the last 3 days before study enrolment
7. Patients requiring antibiotic treatment for any condition at study entry
c) General
1. Parallel participation in any other clinical study, participation in
another study within less than 6 weeks prior to study entry, or previous
participation in this same study
2. Pregnant, lactating women or women capable of bearing children
rejecting the use of reliable contraceptives (Pearl-lndex < 1)
3. Legal incapacity and / or other circumstances rendering the patient
unable to understand the nature, scope and possible impact of the study
4. Patients in custody by juridical or official order
5. Uncooperative patients
6. Patients who have difficulties in understanding the language
(German) in which the patient information is given
7. Patients who are in a dependent relationship with the Sponsor, the
investigator, other study team members, or the study center
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Comparison of the Change within the mean BSSinv (Baseline to Day 7) between both Treatment groups;Secondary Objective: Change of single symptoms BSSinv between V1, V2, V3 and V4 within the course of the study<br>Change of single symptoms BSSinv between V1, V2, V3 and V4 and within the course of the study<br>rate of AB taking patients between V1 and V4<br>rate of cured patients between V1-V4 (responder)<br>comparison of non-responder rate between V1 and V4<br>Evaluation of efficacy by the investigator (V2, V3, V4)<br>Change in CAT during Treatment course<br>Change in SF-12 during Treatment course<br>;Primary end point(s): Comparison of the Change within the mean BSSinv (Baseline to Day 7) between both Treatment groups;Timepoint(s) of evaluation of this end point: day 7
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Change of single symptoms BSSinv between V1, V2, V3 and V4 within the course of the study<br>Change of single symptoms BSSinv between V1, V2, V3 and V4 and within the course of the study<br>rate of AB taking patients between V1 and V4<br>rate of cured patients between V1-V4 (responder)<br>comparison of non-responder rate between V1 and V4<br>Evaluation of efficacy by the investigator (V2, V3, V4)<br>Change in CAT during Treatment course<br>Change in SF-12 during Treatment course<br>;Timepoint(s) of evaluation of this end point: After Treatment Phase (max. 12 days)