A double blind randomised placebo-controlled trial of amoxycillin and budesonide in patients with acute rhinosinusitis in general practice
| ISRCTN | ISRCTN84277311 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN84277311 |
| Protocol serial number | SEO 133 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive South East (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 15/12/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ian Williamson
Scientific
Scientific
Department of Primary Medical Care
University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Double blind randomised placebo-controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | Antibiotics are widely prescribed for acute symptomatic rhinosinusitis in general practice despite marginal evidence for their benefit. Other potential anti-inflammatory agents may help, in particular topical steroids are under researched. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Ear, nose and throat diseases: Ear, nose and throat diseases |
| Intervention | 1. Amoxycillin tablets 500 mg twice daily for 10 days versus placebo 2. Budesonide nasal spray 200 µg each nostril once daily for 10 days versus placebo |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Amoxycillin, budesonide |
| Primary outcome measure(s) |
The percentage with diary recorded complete resolution of all symptoms (cured) at 14 days. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/08/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Not Specified |
| Target sample size at registration | 240 |
| Key inclusion criteria | Patients 16 years or over attending the GP for acute rhinosinusitis, who agree to be randomised. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/09/2001 |
| Date of final enrolment | 31/08/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Department of Primary Medical Care
Southampton
SO16 5ST
United Kingdom
SO16 5ST
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 05/12/2007 | Yes | No |
