The effect of intranasal sodium cromoglycate on symptoms of suspected acute viral upper respiratory tract infection (URTI) in children

ISRCTN	ISRCTN21562211
DOI	https://doi.org/10.1186/ISRCTN21562211
Protocol serial number	G9900236
Sponsor	Medical Research Council (MRC) (UK)
Funder	Medical Research Council (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Christopher C Butler
Scientific

Department of General Practice
University of Wales College of Medicine Health Centre Maelfa
Llanedeyrn
Cardiff
CF23 9PN
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	SAVIT Study
Study objectives	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(s)	Not provided at time of registration.
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	CARIFS Scale Score
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/08/2000

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	300
Key inclusion criteria	Children aged from 6 months to 6 years with suspected acute viral URTI for less than 36 h
Key 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.
Date of first enrolment	01/09/1999
Date of final enrolment	31/08/2000

Department of General Practice

Cardiff
CF23 9PN
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results:	22/06/2002		Yes	No