acute bronchitis
Conditions
Interventions
Trade Name: Tavipec
Product Name: Tavipec
Product Code: 10571
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
Montavit Ges.m.b.H.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adults of both genders from = 18 - 75 years 2. Broca-index between 0.75 and 1.30 3. Clinical diagnosis of acute bronchitis: o = 10 coughing fits during the last day prior to screening visit o Baseline Bronchitis Severity Score (BSS) = 5 points ( of max. 20 points) o Onset of first symptoms within 2 days before start of treatment 4. Informed consent and willingness to comply with the protocol 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 260 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 260
Exclusion criteria
Exclusion criteria: - History or presence of confounding respiratory disease: • Upper respiratory tract infection within the last 4 weeks • Chronic bronchitis • COPD • Acute exacerbations thereof bronchiectasis, asthma, suspected pneumonia, cystic fibrosis, lung cancer - Active cigarette smoking > 10/day - Concomitant bacterial infection - Elevated body temperature (> 39,5°C rectally or > 39,0°C axillary or otic) - Malignant disease of any origin - Known or suspected hypersensitivity to the active substance and/or to any of the excipients - Need for antibiotic treatment in patients at high risk of serious complications because of pre-existing comorbidity, including significant heart, lung, renal, liver or neuromuscular disease, immunosuppression, cystic fibrosis, human immunodeficiency virus infection, malignancy other than squamous or basal cell carcinoma of the skin. - Antibiotic therapy (local or systemic) at any time during the preceding four weeks - Need for application of concomitant local medications including antibiotics, corticosteroids, antihistaminic agents - Immunosuppressive therapy and/or systemic or inhalative glycocorticosteroids - antiotensin converting enzyme (ACE) inhibitors - Systemic antihistaminic agents - secrelytica, mucolytics, expectorants, and bronchodilatatory agents - Radiation therapy or chemotherapy within the previous 12 months - Pregnancy or breastfeeding - History of alcohol or drug abuse likely to lead to uncooperative behaviour - History of psychiatric and/or neurological illness likely to lead to uncooperative behavior - Participation in a clinical research study within the last 6 weeks - Evidence or suspicion of non-compliance - Inability to provide informed consent - Patients using medication for treatment of common cold like symptoms
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Mean difference of a defined total bronchitis severity score (BSS) of 25% between the verum group and the placebo group after 7 days of full medication dose ;Secondary Objective: - Mean difference of a defined total bronchitis severity score (BSS) of 25% between the verum group and the placebo group after 10 days of full medication dose - Global impact of disease on QOL as assessed by patient after 7 and 10 days of full medication dose - Adverse event rate ;Primary end point(s): Mean difference of a defined total bronchitis severity score (BSS) of 25% between the verum group and the placebo group after 7 days of full medication dose ;Timepoint(s) of evaluation of this end point: after 7 days of full medication dose | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Mean difference of a defined total bronchitis severity score (BSS) of 25% between the verum group and the placebo group after 10 days of full medication dose - Global impact of disease on QOL as assessed by patient after 7 and 10 days of full medication dose - Adverse event rate;Timepoint(s) of evaluation of this end point: at baseline, after 7 and 10 days of full medication dose | — |
Countries
Austria
Contacts
Public Contactclinical trial manager
Montavit Ges.m.b.H.
Outcome results
None listed