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

ISRCTN	ISRCTN23032971
DOI	https://doi.org/10.1186/ISRCTN23032971
Protocol serial number	P02278
Sponsor	Schering-Plough AS (Norway)
Funder	Schering-Plough in the Nordic countries

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Prof Rolf Haye
Scientific

Dept. of Otolaryngology
Rikshospitalet
Oslo
0027
Norway

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Desloratadine
Primary outcome measure(s)	The mean change from baseline for the AM last hour total symptom score (TSS) over the 2 weeks treatment period.
Key secondary outcome measure(s)	1. Interference with sleep and interference with daily activity 2. The number of hours spent outdoors
Completion date	02/09/2002

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Dept. of Otolaryngology

Oslo
0027
Norway

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	02/02/2005		Yes	No