Effectiveness of anti-inflammatory treatment versus antibiotic therapy and placebo for patients with non-complicated acute bronchitis with purulent sputum. The BAAP Study protocol

A total of 420 patients from 15 to 70 years of age with no associated comorbidity, presenting respiratory tract infection of at least one week of evolution, with cough as the predominant symptom, the presence of purulent expectoration and at least one other symptom of the respiratory tract (dyspnoea, wheezing, chest discomfort or pain), with no alternative explanation such as pneumonia, will be included in a prospective, randomised and controlled, clinical trial with placebo. The patients will be randomised to receive one of three treatments: ibuprofen, amoxycillin and clavulanic acid or placebo for 10 days. The main outcome measure is the number of days with frequent cough defined by the symptom diary with a score of 1 or more.This trial is designed to evaluate the number of days with frequent cough with anti-inflammatory treatment compared with antimicrobial treatment and placebo in previously healthy patients with a clinical picture of acute bronchitis and purulent expectoration. It is hypothesized that anti-inflammatory treatment is more effective than antibiotic treatment to reduce cough, which is the most disturbing symptom for patients with this infection.ISRCTN07852892Acute bronchitis is a clinical term which implies a self-limiting infection of the large airways and is characterized by clinical manifestations of cough without pneumonia [1]. This process affects approximately 5% of adults annually with a greater incidence in the winter. It accounts for 9.4% of the infections attended by family physicians [2]. Acute bronchitis is mainly a viral infection [3,4]. The role of bacteria in this infection continues to be controversial since bronchial biopsies have never demonstrated bacterial invasion. In some cases atypical germs may be involved including Bordetella pertussis, Chlamydophila pneumoniae and Mycoplasma pneumonia [1,5].It is thought that acute bronchitis reflects an inflammatory response to infections of the epithelium of the bronchi. Microscopic exam