Contact information
Type
Scientific
Primary contact
Mr Paul Montgomery
ORCID ID
Contact details
ENT Department
Norfolk & Norwich University Hospital NHS Trust
Colney
Norwich
NR4 7UY
United Kingdom
+44 (0)1603 286286
paul.montgomery@nnuh.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0547111166
Study information
Scientific title
Acronym
Study hypothesis
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
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
Treatment
Patient information sheet
Condition
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 names
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 trial start date
01/07/2002
Overall trial end date
01/07/2004
Reason abandoned (if study stopped)
Lack of staff/facilities/resources
Eligibility
Participant 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.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
60
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/07/2002
Recruitment end date
01/07/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
ENT Department
Norwich
NR4 7UY
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
East Norfolk and Waveney Research Consortium - Norfolk and Norwich University Hospital/Norwich PCT (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
Basic results (scientific)
Publication list