Back to results

Allergic Inflammation in Rhinitis Patients Following Nasal Allergen Challenge

Primary Purpose

Allergic Rhinitis, Asthma

Status

Completed

Phase

Phase 4

Locations

Denmark

Study Type

Interventional

Intervention

INCS

Placebo

About this trial

This is an interventional basic science trial for Allergic Rhinitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Respiratory Diseases, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

INCS

Placebo

Arm Description

Fluticasone propionate 400 microgram daily

Placebo

Outcomes

Primary Outcome Measures

Serum Eosinophil Cationic Protein (ECP)

Secondary Outcome Measures

Serum Eosinophil Peroxidase (EPO)

Nasal lavage Eosinophil Cationic Protein (ECP)

Nasal lavage Eosinophil Peroxidase (EPO)

Blood Eosinophils

Full Information

NCT ID

NCT01657097

First Posted

August 1, 2012

Last Updated

August 3, 2012

Sponsor

University of Aarhus

Collaborators

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT01657097

Brief Title

Allergic Inflammation in Rhinitis Patients Following Nasal Allergen Challenge

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Completed

Study Start Date

February 1997 (undefined)

Primary Completion Date

April 1997 (Actual)

Study Completion Date

April 1997 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Aarhus

Collaborators

GlaxoSmithKline

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Allergic Rhinitis, Asthma

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

INCS

Arm Type

Experimental

Arm Description

Fluticasone propionate 400 microgram daily

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo

Intervention Type

Drug

Intervention Name(s)

INCS

Intervention Type

Drug

Intervention Name(s)

Placebo

Primary Outcome Measure Information:

Title

Serum Eosinophil Cationic Protein (ECP)

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Serum Eosinophil Peroxidase (EPO)

Time Frame

1 month

Title

Nasal lavage Eosinophil Cationic Protein (ECP)

Time Frame

1 month

Title

Nasal lavage Eosinophil Peroxidase (EPO)

Time Frame

1 month

Title

Blood Eosinophils

Time Frame

1 month

Other Pre-specified Outcome Measures:

Title

Bronchial metacholine challenge

Time Frame

1 month

Title

Acoustic rhinometry

Time Frame

1 month

Title

Spirometry (Forced Expiratory Volume 1 second (FEV-1))

Time Frame

1 month

Title

Nasal symptom score

Time Frame

1 month

Title

Asthma symptom score

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ronald Dahl, MD

Organizational Affiliation

Department of Respiratory Diseases, Aarhus University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Department of Respiratory Diseases, Aarhus University Hospital

City

Aarhus

ZIP/Postal Code

DK-8000 C

Country

Denmark

12. IPD Sharing Statement

Learn more about this trial

Allergic Inflammation in Rhinitis Patients Following Nasal Allergen Challenge

We'll reach out to this number within 24 hrs