Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
G9900236
Study information
Scientific title
Acronym
SAVIT Study
Study hypothesis
The trial is designed to answer the question; "In children presenting in general practice with suspected acute viral upper respiratory tract infection of less than 36 h duration, does treatment with intranasal sodium cromoglycate improve symptoms more than placebo?"
Ethics approval
Not provided at time of registration.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
Primary care
Intervention
300 children will be randomised to receive either normal saline nose spray or sodium cromoglycate 4% nose spray every 2 h (during waking hours) for the first 2 days, and every 4 h for a further 5 days or until quite well.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
CARIFS Scale Score
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/09/1999
Overall trial end date
31/08/2000
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Children aged from 6 months to 6 years with suspected acute viral URTI for less than 36 h
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
300
Participant exclusion criteria
Children with: a history of having taken cromolyns or steroids within the previous week; carers who are incapable of giving informed consent or unable to keep symptom diaries; an established complication requiring immediate hospitalisation, or for whom the clinician plans to prescribe antibiotics at the first consultation.
Recruitment start date
01/09/1999
Recruitment end date
31/08/2000
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of General Practice
Cardiff
CF23 9PN
United Kingdom
Sponsor information
Organisation
Medical Research Council (MRC) (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
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
Publication citations
-
Results
Butler CC, Robling M, Prout H, Hood K, Kinnersley P, Management of suspected acute viral upper respiratory tract infection in children with intranasal sodium cromoglicate: a randomised controlled trial., Lancet, 2002, 359, 9324, 2153-2158, doi: 10.1016/S0140-6736(02)09091-8.