Condition category
Respiratory
Date applied
23/10/2000
Date assigned
23/10/2000
Last edited
13/09/2007
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 Christopher C Butler

ORCID ID

Contact details

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

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 measures

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

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 20 7636 5422
clinical.trial@headoffice.mrc.ac.uk

Sponsor type

Research council

Website

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=12090980

Publication citations

  1. 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.

Additional files

Editorial Notes