Efectividad del tratamiento antiinflamatorio versus antibiótico y placebo en pacientes con bronquits aguda no complicada con esputo purulento - BAAP Study

• Conditions: Pacientes de 18 a 65 años que presentan bronquitis aguda con esputo purulento; MedDRA version: 9.1Level: LLTClassification code 10000687Term: Acute bronchitis

• Registration Number: EUCTR2007-006727-12-ES
• Lead Sponsor: Institut Català de la Salut

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-02-13
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Patients aged 15 to 65, without significant comorbidities, who present a respiratory tract infection of less than one week, with cough as the fundamental symptom and presence of purulent sputum and at least another symptom of respiratory tract, such as dyspnea, wheezing, thoracic disconfort, and/or pain, that cannot be explained by another disease such as pneumonia.
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) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Radiological sign of pneumonia
2. Signs of severe infection: confusion, respiratory rate over 25 bretahs/minute, heart rate over 120 beats/minute
3. History of digestive bleeding or intolerance to anti-inflammatory treatment
4. Hypersensitivity to betalactams or intolenace to amoxicillin and clavulanic acid
5. Pregnancy
6. Antibiotic or anti-inflammatory drugs taken over the last two weeks
7. Significant comorbidities associated, such as asthma, chronic obstructive pulmonary disease, immunodepression and immunosupressive drugs

Study & Design

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