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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
Results in http://www.ncbi.nlm.nih.gov/pubmed/15686600
Publication citations
-
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.