Efficacy and Safety of Tavipexc versus Placebo in patients with acute Bronchitis

Phase 1

• Conditions: acute bronchitis; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2013-004836-31-AT
• Lead Sponsor: Montavit Ges.m.b.H.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-01-30
• Last Update Posted: 20 June 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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
oBaseline Bronchitis Severity Score (BSS) = 5 points ( of max. 20 points)
oOnset 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

-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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified