|
ISRCTN
|
ISRCTN23032971
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Morning versus evening dosing of desloratadine in seasonal allergic rhinitis: a randomised controlled study
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
P02278
|
|
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).
|
|
Lay summary
|
|
|
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
|
|
Countries of recruitment
|
Denmark, Finland, Iceland, Norway, Sweden
|
|
Disease/condition/study domain
|
Seasonal allergic rhinitis
|
|
Participants - 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
|
|
Participants - 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
|
|
Anticipated start date
|
11/04/2001
|
|
Anticipated end date
|
02/09/2002
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
663
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
The mean change from baseline for the AM last hour total symptom score (TSS) over the 2 weeks treatment period.
|
|
Secondary outcome measure(s)
|
1. Interference with sleep and interference with daily activity
2. The number of hours spent outdoors
|
|
Sources of funding
|
Schering-Plough in the Nordic countries
|
|
Trial website
|
|
|
Publications
|
Results in http://www.ncbi.nlm.nih.gov/pubmed/15686600
|
|
Contact name
|
Prof
Rolf
Haye
|
|
Address
|
Dept. of Otolaryngology
Rikshospitalet
|
|
City/town
|
Oslo
|
|
Zip/Postcode
|
0027
|
|
Country
|
Norway
|
|
Sponsor
|
Schering-Plough AS (Norway)
|
|
Address
|
Ankerv. 209
|
|
City/town
|
Eiksmarka
|
|
Zip/Postcode
|
1359
|
|
Country
|
Norway
|
|
Date applied
|
31/01/2005
|
|
Last edited
|
18/02/2008
|
|
Date ISRCTN assigned
|
01/02/2005
|
