Allergic Inflammation in Rhinitis Patients Following Nasal Allergen Challenge

Allergic Inflammation in Rhinitis Patients Following Nasal Allergen Challenge. Impact on Bronchial Hyperresponsiveness and the Effect of Intranasal Corticosteroid Treatment

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 Overview

• Status: Completed
• Conditions: Asthma; Allergic Rhinitis
• Intervention / Treatment: Drug: Placebo; Drug: INCS

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Phase 4

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, DK-8000 C
    • Department of Respiratory Diseases, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Placebo	Drug: Placebo
EXPERIMENTAL: INCS; Fluticasone propionate 400 microgram daily	Drug: INCS

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Serum Eosinophil Cationic Protein (ECP)	1 month

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Other Outcome Measures

Outcome Measure	Time Frame
Bronchial metacholine challenge	1 month
Acoustic rhinometry	1 month
Spirometry (Forced Expiratory Volume 1 second (FEV-1))	1 month
Nasal symptom score	1 month
Asthma symptom score	1 month

Collaborators and Investigators

• Sponsor: University of Aarhus
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Ronald Dahl, MD, Department of Respiratory Diseases, Aarhus University Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 1997
• Primary Completion (ACTUAL): April 1, 1997
• Study Completion (ACTUAL): April 1, 1997

Study Registration Dates

• First Submitted: August 1, 2012
• First Submitted That Met QC Criteria: August 1, 2012
• First Posted (ESTIMATE): August 3, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): August 6, 2012
• Last Update Submitted That Met QC Criteria: August 3, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Inflammation; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: RHINO97