Condition category
Respiratory
Date applied
02/03/2010
Date assigned
04/03/2011
Last edited
28/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 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

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 measures

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

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 d’Investigació 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

http://www.idiapjgol.org

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

Results - basic reporting

Publication summary

2011 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/21693045
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24097128

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes