Morning versus evening dosing of desloratadine in seasonal allergic rhinitis: a randomised controlled study
ISRCTN | ISRCTN23032971 |
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DOI | https://doi.org/10.1186/ISRCTN23032971 |
Secondary identifying numbers | P02278 |
- Submission date
- 31/01/2005
- Registration date
- 01/02/2005
- Last edited
- 18/02/2008
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Respiratory
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Rolf Haye
Scientific
Scientific
Dept. of Otolaryngology
Rikshospitalet
Oslo
0027
Norway
Study information
Study design | Randomised controlled trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Scientific title | |
Study objectives | 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. |
Health condition(s) or problem(s) studied | 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 |
Completion date | 02/09/2002 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 663 |
Key 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 |
Key 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 |
Date of first enrolment | 11/04/2001 |
Date of final enrolment | 02/09/2002 |
Locations
Countries of recruitment
- Denmark
- Finland
- Iceland
- Norway
- Sweden
Study participating centre
Dept. of Otolaryngology
Oslo
0027
Norway
0027
Norway
Sponsor information
Schering-Plough AS (Norway)
Industry
Industry
Ankerv. 209
Eiksmarka
1359
Norway
https://ror.org/0118bra88 |
Funders
Funder type
Industry
Schering-Plough in the Nordic countries
No information available
Results and Publications
Intention to publish date | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
Results article | Results | 02/02/2005 | Yes | No |