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Clinical Trials/ISRCTN07852892
ISRCTN07852892
Completed
Not Applicable

Effectiveness of anti-inflammatory treatment versus antibiotic therapy and placebo in patients with acute bronchitis and purulent sputum: a double-blind randomised controlled clinical trial

Primary Care Research Institute Jordi Gol i Gurina (Institut d?Investigació en Atenció Primària Jordi Gol i Gurina) (Spain)0 sites420 target enrollmentMarch 4, 2011

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Acute bronchitis and purulent sputum
Sponsor
Primary Care Research Institute Jordi Gol i Gurina (Institut d?Investigació en Atenció Primària Jordi Gol i Gurina) (Spain)
Enrollment
420
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 4, 2011
End Date
TBD
Last Updated
11 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Primary Care Research Institute Jordi Gol i Gurina (Institut d?Investigació en Atenció Primària Jordi Gol i Gurina) (Spain)

Eligibility Criteria

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

Outcomes

Primary Outcomes

Not specified

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