Allergic Inflammation in Rhinitis Patients Following Nasal Allergen Challenge

Phase 4

Completed

• Conditions: Asthma; Allergic Rhinitis
• Interventions: Drug: INCS; Drug: Placebo

• Registration Number: NCT01657097
• Lead Sponsor: University of Aarhus

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 1997-02
• Primary Completion: 1997-04
• Study Completion: 1997-04
• Status Verified: 2012-08
• Study First Submitted: 2012-08-01
• Study First Submitted QC: 2012-08-01
• Study First Posted: 2012-08-03
• Last Update Submitted: 2012-08-03
• Last Update Posted: 2012-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

• monoallergy to grass
• symptoms of allergic rhinitis for at least the two most recent grasspollen seasons
• asthma symptoms of asthma for at least two of the four most recent grasspollen seasons
• age 18 or older

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Exclusion Criteria

• pregnancy or lactation
• fertile women, not sterilised or using sufficient anticonception
• Corticosteroid treatment (parenteral, oral, inhaled or intranasal) within two months prior to enrolment
• Any other disease, condition or treatment, which to the discretion of the investigator has the potential to interfere with study results

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
INCS	INCS	Fluticasone propionate 400 microgram daily
Placebo	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
Serum Eosinophil Cationic Protein (ECP)	1 month

Secondary Outcome Measures

Name	Time	Method
Serum Eosinophil Peroxidase (EPO)	1 month
Nasal lavage Eosinophil Cationic Protein (ECP)	1 month
Nasal lavage Eosinophil Peroxidase (EPO)	1 month
Blood Eosinophils	1 month

Trial Locations

Locations (1)

Department of Respiratory Diseases, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark