Condition category
Ear, Nose and Throat
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
15/12/2008
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 Ian Williamson

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

SEO 133

Study information

Scientific title

Acronym

Study hypothesis

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

Not provided at time of registration

Study design

Double blind randomised placebo-controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

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 names

Amoxycillin, budesonide

Primary outcome measures

The percentage with diary recorded complete resolution of all symptoms (cured) at 14 days.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2001

Overall trial end date

31/08/2004

Reason abandoned

Eligibility

Participant inclusion criteria

Patients 16 years or over attending the GP for acute rhinosinusitis, who agree to be randomised.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

Added December 2008: 240

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/09/2001

Recruitment end date

31/08/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Primary Medical Care
Southampton
SO16 5ST
United Kingdom

Sponsor information

Organisation

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

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive South East (UK)

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

2007 results in http://www.ncbi.nlm.nih.gov/pubmed/18056902

Publication citations

  1. Results

    Williamson IG, Rumsby K, Benge S, Moore M, Smith PW, Cross M, Little P, Antibiotics and topical nasal steroid for treatment of acute maxillary sinusitis: a randomized controlled trial., JAMA, 2007, 298, 21, 2487-2496, doi: 10.1001/jama.298.21.2487.

Additional files

Editorial Notes