Seasonal allergic rhinitis Respiratory Allergic rhinitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The mean change from baseline for the AM last hour total symptom score (TSS) over the 2 weeks treatment period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Interference with sleep and interference with daily activity 2. The number of hours spent outdoors | — |
Countries
Denmark, Finland, Iceland, Norway, Sweden