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
Scientific
Department of General Practice
University of Wales College of Medicine Health Centre Maelfa
Llanedeyrn
Cardiff
CF23 9PN
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| 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 | CARIFS Scale Score |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/09/1999 |
| Completion date | 31/08/2000 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 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 |
Locations
Countries of recruitment
- United Kingdom
- Wales
Study participating centre
Department of General Practice
Cardiff
CF23 9PN
United Kingdom
CF23 9PN
United Kingdom
Sponsor information
Medical Research Council (MRC) (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| 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
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
