Allergic Inflammation in Rhinitis Patients Following Nasal Allergen Challenge

NCT ID: NCT01657097

Last Updated: 2012-08-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-02-28

Study Completion Date

1997-04-30

Brief Summary

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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

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Conditions

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Allergic Rhinitis Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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INCS

Fluticasone propionate 400 microgram daily

Group Type EXPERIMENTAL

INCS

Intervention Type DRUG

Placebo

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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INCS

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ronald Dahl, MD

Role: PRINCIPAL_INVESTIGATOR

Department of Respiratory Diseases, Aarhus University Hospital

Locations

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Department of Respiratory Diseases, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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RHINO97

Identifier Type: -

Identifier Source: org_study_id