Effectiveness of anti-inflammatory treatment versus antibiotic therapy and placebo in patients with acute bronchitis and purulent expectoratio

Completed

• Conditions: Acute bronchitis and purulent sputum; Respiratory; Acute bronchitis

• Registration Number: ISRCTN07852892
• Lead Sponsor: Primary Care Research Institute Jordi Gol i Gurina (Institut d?Investigació en Atenció Primària Jordi Gol i Gurina) (Spain)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-04
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 420

Inclusion Criteria

Patients from 18 to 70 years of age without associated respiratory comorbidity or immunosuppression will be recruited from seven healthcare centers in Catalonia.
1. Presenting respiratory infection of at least one week of evolution
2. Cough as the predominant symptom
3. Presence of purulent expectoration of at least one week of duration
4. At least one other respiratory tract symptom such as dyspnoea, wheezing, chest discomfort or pain, with no alternative explanation such as pneumonic condensation

Exclusion Criteria

1. Patients less than 18 and older than 70 years of age
2. Presence of radiological signs of pneumonia
3. Signs of severe infection
3.1. confusion
3.2. tachypnoea > 25 respirations per minute of tachycardia > 120 beats per minute
4. History of digestive haemorrhage or intolerance to anti-inflammatory treatment
5. Hypersensitivity to ß-lactam or intolerance to clavulanic acid or lactose
6. Pregnancy, lactation and women of fertile age not using contraceptive measures
7. Antibiotic, anti-inflammatory or corticoid use in the previous two weeks
8. Associated comorbidity
8.1. bronchial asthma
8.2. chronic obstructive pulmonary disease
8.3. moderate-severe heart failure
8.4. dementia
8.5. stroke
8.6. immunosupression or the use of immunosuppressive drugs
9. Emergency situation
10. Institutionalisation in a residence
11. And/or subjects unable to personally provide informed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of days with frequent cough

Secondary Outcome Measures

Name	Time	Method
Secondary result variables considered will be the efficacy of the treatment, the time of symptom resolution, the reduction in the total daily score of the symptom diary and the secondary effects and adverse reactions which may present with the three treatment arms. With regard to efficacy, three outcomes will be distinguished: cure, defined as the disappearance of the acute signs and symptoms related to the infection (complete return to the previous situation of stability), improvement, defined as the non complete resolution of the symptoms and failure, with an insufficient reduction in the signs and symptoms of infection.