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
Secondary identifying numbers SEO 133
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

Department of Primary Medical Care
University of Southampton
Aldermoor Health Centre
Aldermoor Close
Southampton
SO16 5ST
United Kingdom

Study information

Study designDouble blind randomised placebo-controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectivesAntibiotics 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) studiedEar, nose and throat diseases: Ear, nose and throat diseases
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Amoxycillin, budesonide
Primary outcome measureThe percentage with diary recorded complete resolution of all symptoms (cured) at 14 days.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/09/2001
Completion date31/08/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexNot Specified
Target number of participantsAdded December 2008: 240
Key inclusion criteriaPatients 16 years or over attending the GP for acute rhinosinusitis, who agree to be randomised.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/09/2001
Date of final enrolment31/08/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Primary Medical Care
Southampton
SO16 5ST
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive South East (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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