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

• Conditions: acute bronchitis; MedDRA version: 13.1Level: LLTClassification code 10000687Term: Acute bronchitisSystem Organ Class: 10021881 - Infections and infestations

• Registration Number: EUCTR2010-022819-19-DE
• Lead Sponsor: G. Pohl-Boskamp GmbH & Co. KG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10-29
• Last Update Posted: 10 February 2014

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

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