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
Secondary identifying numbers G9900236
Submission date
23/10/2000
Registration date
23/10/2000
Last edited
13/09/2007
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Christopher C Butler
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymSAVIT Study
Study objectivesThe 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) studiedPrimary care
Intervention300 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 typeOther
Primary outcome measureCARIFS Scale Score
Secondary outcome measuresNot provided at time of registration
Overall study start date01/09/1999
Completion date31/08/2000

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants300
Key inclusion criteriaChildren aged from 6 months to 6 years with suspected acute viral URTI for less than 36 h
Key exclusion criteriaChildren 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 enrolment01/09/1999
Date of final enrolment31/08/2000

Locations

Countries of recruitment

  • United Kingdom
  • Wales

Study participating centre

Department of General Practice
Cardiff
CF23 9PN
United Kingdom

Sponsor information

Medical Research Council (MRC) (UK)
Research council

20 Park Crescent
London
W1B 1AL
United Kingdom

Phone +44 (0)20 7636 5422
Email clinical.trial@headoffice.mrc.ac.uk
Website http://www.mrc.ac.uk

Funders

Funder type

Research council

Medical Research Council (UK)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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