Condition category
Respiratory
Date applied
31/01/2005
Date assigned
01/02/2005
Last edited
18/02/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Rolf Haye

ORCID ID

Contact details

Dept. of Otolaryngology
Rikshospitalet
Oslo
0027
Norway

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

P02278

Study information

Scientific title

Acronym

Study hypothesis

The aim of this study was to examine the efficacy of the antihistamine desloratadine at different time points during the day and to evaluate whether the time of dosing of desloratadine has any impact on the treatment efficacy in seasonal allergic rhinitis (SAR).

Ethics approval

The study protocol and the patient informed consent form were approved by Ethics Committees and Health Authorities in each of the participating countries.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Seasonal allergic rhinitis

Intervention

Patients were randomised into one of two treatment groups with dosing of 5 mg desloratadine tablets either in the morning between 07 - 09 (AM-group) or evening between 19 - 21 (PM-group) in a 1:1 ratio.

Intervention type

Drug

Phase

Not Specified

Drug names

Desloratadine

Primary outcome measures

The mean change from baseline for the AM last hour total symptom score (TSS) over the 2 weeks treatment period.

Secondary outcome measures

1. Interference with sleep and interference with daily activity
2. The number of hours spent outdoors

Overall trial start date

11/04/2001

Overall trial end date

02/09/2002

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients 18 years or above with a minimum of two years history of SAR confirmed by either a positive skin prick test or a positive serologic allergen test to the relevant seasonal allergen
2. Clinically symptomatic with SAR at baseline/inclusion with a minimum total nasal symptom score (rhinorrhoea, congestion, itching and sneezing) of at least 6 and rhinorrhoea being minimum 2 (moderate)
3. Willingness to adhere to dosing and visit schedule
4. Females of childbearing potential have to use medically accepted methods of birth control
5. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

663

Participant exclusion criteria

1. Pulmonary disease, perennial rhinitis, sinusitis, rhinitis medicamentosa, pollen desensitisation during the last 6 months
2. Respiratory tract infection within the last two weeks
3. Structural nasal abnormalities (including polyps)
4. Use of oral, nasal, ocular decongestants, corticosteroids in any form (except mild dermatological group I corticosteroids allowed in only small areas), other antihistamines (oral or topical), any investigational drug during the last 30 days
5. Pregnant or nursing females

Recruitment start date

11/04/2001

Recruitment end date

02/09/2002

Locations

Countries of recruitment

Denmark, Finland, Iceland, Norway, Sweden

Trial participating centre

Dept. of Otolaryngology
Oslo
0027
Norway

Sponsor information

Organisation

Schering-Plough AS (Norway)

Sponsor details

Ankerv. 209
Eiksmarka
1359
Norway

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Schering-Plough in the Nordic countries

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

Results in http://www.ncbi.nlm.nih.gov/pubmed/15686600

Publication citations

  1. Results

    Haye R, Høye K, Berg O, Frønes S, Odegård T, Morning versus evening dosing of desloratadine in seasonal allergic rhinitis: a randomized controlled study [ISRCTN23032971]., Clin Mol Allergy, 2005, 3, 1, 3, doi: 10.1186/1476-7961-3-3.

Additional files

Editorial Notes