A comparison study of leukotriene receptor antagonist plus topical nasal steroid versus oral antihistamine + topical nasal steroid versus leukotriene receptor antagonist + oral antihistamine + topical nasal in the treatment of perennial allergic rhinitis
| ISRCTN | ISRCTN02329306 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN02329306 |
| Secondary identifying numbers | N0547111166 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 18/11/2009
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Mr Paul Montgomery
Scientific
Scientific
ENT Department
Norfolk & Norwich University Hospital NHS Trust
Colney
Norwich
NR4 7UY
United Kingdom
| Phone | +44 (0)1603 286286 |
|---|---|
| paul.montgomery@nnuh.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | How effective is leukotriene receptor antagonist plus topical nasal steroid versus oral antihistamine + topical nasal steroid versus leukotriene receptor antagonist + oral antihistamine + topical nasal steroid in the treatment of perennial allergic rhinitis? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Respiratory: Allergic rhinitis |
| Intervention | Patients are randomised into one of three groups: Group 1: leukotriene receptor antagonist plus topical nasal steroid Group 2: oral antihistamine plus topical nasal steroid Group three: leukotriene receptor antagonist, oral antihistamine plus topical nasal steroid Added 18/11/09: trial stopped due to lack of resources. |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Leukotriene receptor antagonist, oral antihistamine, topical nasal steroid |
| Primary outcome measure | Symptom scores at 12 week assessment |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/07/2002 |
| Completion date | 01/07/2004 |
| Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 60 |
| Key inclusion criteria | 60 patients (20 in each group), patients seen in out-patients with symptoms, signs and test results consistent with perennial allergic rhinitis will be placed on a six-week course of topical nasal steroid spray. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/07/2002 |
| Date of final enrolment | 01/07/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
ENT Department
Norwich
NR4 7UY
United Kingdom
NR4 7UY
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
East Norfolk and Waveney Research Consortium - Norfolk and Norwich University Hospital/Norwich PCT (UK)
No information available
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 |
