Allergic Inflammation in Rhinitis Patients Following Nasal Allergen Challenge
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|ClinicalTrials.gov Identifier: NCT01657097|
Recruitment Status : Completed
First Posted : August 3, 2012
Last Update Posted : August 6, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Allergic Rhinitis Asthma||Drug: INCS Drug: Placebo||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, 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|
|Study Start Date :||February 1997|
|Primary Completion Date :||April 1997|
|Study Completion Date :||April 1997|
Fluticasone propionate 400 microgram daily
Placebo Comparator: Placebo
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|