Condition category
Respiratory
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
18/11/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Stopped
Recruitment status
Stopped

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.doh.gov.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes