Welcome
Support Centre
24 April 2014 
ISRCTN Register - International Standard Randomized Controlled Trial Number
Trial registration
Unique identification scheme
International databases
home  |   my details  |   ISRCTN Register  |   mRCT  |   links  |   information  |   news
Find trials
ISRCTN Register
tips on searching

Registration
New application
Updating record

Information
introduction
governing board
ISRCTN FAQs
data set
letter of agreement
request information
guidance notes
statistics

[ Print-friendly version ]
Effectiveness of anti-inflammatory treatment versus antibiotic therapy and placebo in patients with acute bronchitis and purulent expectoration
ISRCTN ISRCTN07852892
DOI 10.1186/ISRCTN07852892
ClinicalTrials.gov identifier
EudraCT number 2007-006727-12
Public title Effectiveness of anti-inflammatory treatment versus antibiotic therapy and placebo in patients with acute bronchitis and purulent expectoration
Scientific title 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
Acronym BAAP Study
Serial number at source E07/90333
Study hypothesis The number of days of frequent cough (defined by the symptom diary with a score of 1 or more) among patients taking the anti-inflammatory drug will be fewer than among patients assigned to the other two arms.
Lay summary Not provided at time of registration
Ethics approval 1. The Ethical Committee of Investigation in Primary Care (Fundació d’Investigació en Atenció Primària) approved on the 2nd of December 2007 (ref: P07/15)
2. Spanish Agency of Medicines and Health Products (Agencia Española de Medicamentos y Productos Sanitarios [AEMPS]) and the EudraCT approved (ref: 2007-006727-12)
Study design Double blind randomised controlled clinical trial
Countries of recruitment Spain
Disease/condition/study domain Acute bronchitis and purulent sputum
Participants - 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
Participants - 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 β-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
Anticipated start date 01/04/2010
Anticipated end date 31/03/2011
Status of trial Completed
Patient information material Not available in web format, please use contact details below to request a patient information sheet
Target number of participants Total of 420 patients
Interventions The patients will be randomised with simple random numbers to one of the three following treatment arms:
1. Ibuprofen 600 mg/8 hours, during 10 days, taken after meals
2. Amoxycillin plus clavulanic acid 500-125 mg/8 hours, during 10 days, taken after meals
3. Placebo, one tablet every 8 hours, during 10 days, taken after meals
Primary outcome measure(s) Number of days with frequent cough
Secondary outcome measure(s) 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.
Sources of funding Health Research Fund of the Ministry of Health and Consumption (Fondo de Investigación Sanitaria de Ministerio de Sanidad y Consumo) (Spain) (EC07/90333)
Trial website
Publications 2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21693045
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24097128
Contact name Dr  Ana  Moragas
  Address Av. Horta de Santa Maria, 4, 3r 4a
  City/town Cambrils
  Zip/Postcode 43850
  Country Spain
  Tel +34 (0)60 007 21 70
  Email amoragasm@meditex.es
Sponsor Primary Care Research Institute Jordi Gol i Gurina (Institut d’Investigació en Atenció Primària Jordi Gol i Gurina) (Spain)
  Address Av. Gran Via de les Corts Catalanes
587, Àtic
  City/town Barcelona
  Zip/Postcode 08007
  Country Spain
  Tel +34 (0)93 482 41 24
  Fax +34 (0)93 482 41 74
  Email cviolan@idiapjgol.org
  Sponsor website: http://www.idiapjgol.org
Date applied 02/03/2010
Last edited 28/10/2013
Date ISRCTN assigned 04/03/2011
Submit your trial protocol
Submit to Trials journal
Follow us on Twitter
© 2014 ISRCTN unless otherwise stated.