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 |
| Protocol serial number | N0547111166 |
| Sponsor | Department of Health (UK) |
| Funder | East Norfolk and Waveney Research Consortium - Norfolk and Norwich University Hospital/Norwich PCT (UK) |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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 |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Leukotriene receptor antagonist, oral antihistamine, topical nasal steroid |
| Primary outcome measure(s) |
Symptom scores at 12 week assessment |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/07/2004 |
| Reason abandoned (if study stopped) | Lack of staff/facilities/resources |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
ENT Department
Norwich
NR4 7UY
United Kingdom
NR4 7UY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
