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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/18056902
Publication citations
-
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.