Morning versus evening dosing of desloratadine in seasonal allergic rhinitis: a randomised controlled study

ISRCTN ISRCTN23032971
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

Dept. of Otolaryngology
Rikshospitalet
Oslo
0027
Norway

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesThe 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) studiedSeasonal allergic rhinitis
InterventionPatients 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)Desloratadine
Primary outcome measureThe mean change from baseline for the AM last hour total symptom score (TSS) over the 2 weeks treatment period.
Secondary outcome measures1. Interference with sleep and interference with daily activity
2. The number of hours spent outdoors
Overall study start date11/04/2001
Completion date02/09/2002

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants663
Key inclusion criteria1. 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 criteria1. 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 enrolment11/04/2001
Date of final enrolment02/09/2002

Locations

Countries of recruitment

  • Denmark
  • Finland
  • Iceland
  • Norway
  • Sweden

Study participating centre

Dept. of Otolaryngology
Oslo
0027
Norway

Sponsor information

Schering-Plough AS (Norway)
Industry

Ankerv. 209
Eiksmarka
1359
Norway

ROR logo "ROR" https://ror.org/0118bra88

Funders

Funder type

Industry

Schering-Plough in the Nordic countries

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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