Additional identifiers
EudraCT/CTIS number
IRAS 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(s)
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
Study setting(s)
Hospital
Study 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
Pharmaceutical study type(s)
Phase
Not Specified
Drug/device/biological/vaccine name(s)
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 study start date
11/04/2001
Overall study 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(s)
Patient
Age group
Adult
Lower age limit
18 Years
Sex
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
Study 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
ROR
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
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 02/02/2005 | Yes | No |