Effectiveness of anti-inflammatory treatment versus antibiotic therapy and placebo in patients with acute bronchitis and purulent expectoration
| ISRCTN | ISRCTN07852892 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN07852892 |
| EudraCT/CTIS number | 2007-006727-12 |
| Secondary identifying numbers | E07/90333 |
- Submission date
- 02/03/2010
- Registration date
- 04/03/2011
- Last edited
- 28/10/2013
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ana Moragas
Scientific
Scientific
Av. Horta de Santa Maria, 4, 3r 4a
Cambrils
43850
Spain
| Phone | +34 (0)60 007 21 70 |
|---|---|
| amoragasm@meditex.es |
Study information
| Study design | Double blind randomised controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details below to request a patient information sheet |
| 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 |
| Study acronym | BAAP Study |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/04/2010 |
| Completion date | 31/03/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 70 Years |
| Sex | Both |
| Target number of participants | Total of 420 patients |
| Key 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 |
| Key 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 |
| Date of first enrolment | 01/04/2010 |
| Date of final enrolment | 31/03/2011 |
Locations
Countries of recruitment
- Spain
Study participating centre
Av. Horta de Santa Maria, 4, 3r 4a
Cambrils
43850
Spain
43850
Spain
Sponsor information
Primary Care Research Institute Jordi Gol i Gurina (Institut dInvestigació en Atenció Primària Jordi Gol i Gurina) (Spain)
Government
Government
Av. Gran Via de les Corts Catalanes
587, Àtic
Barcelona
08007
Spain
| Phone | +34 (0)93 482 41 24 |
|---|---|
| cviolan@idiapjgol.org | |
| Website | http://www.idiapjgol.org |
"ROR" |
https://ror.org/0370bpp07 |
Funders
Funder type
Government
Health Research Fund of the Ministry of Health and Consumption (Fondo de Investigación Sanitaria de Ministerio de Sanidad y Consumo) (Spain) (EC07/90333)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 21/06/2011 | Yes | No | |
| Results article | results | 04/10/2013 | Yes | No |
