Contact information
Type
Scientific
Primary contact
Dr Ana Moragas
ORCID ID
Contact details
Av. Horta de Santa Maria
4
3r 4a
Cambrils
43850
Spain
+34 (0)60 007 21 70
amoragasm@meditex.es
Additional identifiers
EudraCT number
2007-006727-12
ClinicalTrials.gov number
Protocol/serial number
E07/90333
Study information
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
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.
Ethics approval
1. The Ethical Committee of Investigation in Primary Care (Fundació dInvestigació 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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use contact details below to request a patient information sheet
Condition
Acute bronchitis and purulent sputum
Intervention
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
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Number of days with frequent cough
Secondary outcome measures
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.
Overall trial start date
01/04/2010
Overall trial end date
31/03/2011
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
Total of 420 patients
Participant 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
Recruitment start date
01/04/2010
Recruitment end date
31/03/2011
Locations
Countries of recruitment
Spain
Trial participating centre
Av. Horta de Santa Maria, 4, 3r 4a
Cambrils
43850
Spain
Sponsor information
Organisation
Primary Care Research Institute Jordi Gol i Gurina (Institut dInvestigació en Atenció Primària Jordi Gol i Gurina) (Spain)
Sponsor details
Av. Gran Via de les Corts Catalanes
587
Àtic
Barcelona
08007
Spain
+34 (0)93 482 41 24
cviolan@idiapjgol.org
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Health Research Fund of the Ministry of Health and Consumption (Fondo de Investigación Sanitaria de Ministerio de Sanidad y Consumo) (Spain) (EC07/90333)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21693045
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24097128
Publication citations
-
Protocol
Llor C, Moragas A, Bayona C, Morros R, Pera H, Cots JM, Fernández Y, Miravitlles M, Boada A, Effectiveness of anti-inflammatory treatment versus antibiotic therapy and placebo for patients with non-complicated acute bronchitis with purulent sputum. The BAAP Study protocol., BMC Pulm Med, 2011, 11, 38, doi: 10.1186/1471-2466-11-38.
-
Results
Llor C, Moragas A, Bayona C, Morros R, Pera H, Plana-Ripoll O, Cots JM, Miravitlles M, Efficacy of anti-inflammatory or antibiotic treatment in patients with non-complicated acute bronchitis and discoloured sputum: randomised placebo controlled trial., BMJ, 2013, 347, f5762.