Allergic Inflammation in Rhinitis Patients Following Nasal Allergen Challenge
Allergic rhinitis is a common condition caused by inflammation of nasal mucosa. The study was performed to gain information on this inflammation, including effect of intranasal corticosteroid treatment hereupon and potential influence on the lower airways, ie asthma.
The study was randomised, placebo-controlled double-blind in patients, monoallergic to grasspollen, presenting symptoms of rhinitis and asthma during season.
Treatment,ie intranasal corticosteroid or placebo, were given four weeks. After two weeks of treatment intranasal allergen challenge was performed. Measurements were performed during the full study period.
The study was performed out of pollen season.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
|Official Title:||Allergic Inflammation in Rhinitis Patients Following Nasal Allergen Challenge. Impact on Bronchial Hyperresponsiveness and the Effect of Intranasal Corticosteroid Treatment|
- Serum Eosinophil Cationic Protein (ECP) [ Time Frame: 1 month ]
- Serum Eosinophil Peroxidase (EPO) [ Time Frame: 1 month ]
- Nasal lavage Eosinophil Cationic Protein (ECP) [ Time Frame: 1 month ]
- Nasal lavage Eosinophil Peroxidase (EPO) [ Time Frame: 1 month ]
- Blood Eosinophils [ Time Frame: 1 month ]
- Bronchial metacholine challenge [ Time Frame: 1 month ]
- Acoustic rhinometry [ Time Frame: 1 month ]
- Spirometry (Forced Expiratory Volume 1 second (FEV-1)) [ Time Frame: 1 month ]
- Nasal symptom score [ Time Frame: 1 month ]
- Asthma symptom score [ Time Frame: 1 month ]
|Study Start Date:||February 1997|
|Study Completion Date:||April 1997|
|Primary Completion Date:||April 1997 (Final data collection date for primary outcome measure)|
Fluticasone propionate 400 microgram daily
Placebo Comparator: Placebo
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657097
|Department of Respiratory Diseases, Aarhus University Hospital|
|Aarhus, Denmark, DK-8000 C|
|Principal Investigator:||Ronald Dahl, MD||Department of Respiratory Diseases, Aarhus University Hospital|