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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01657097

Enrollment

Registered

2012-08-03

Start date

1997-02-28

Completion date

1997-04-30

Last updated

2012-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis, Asthma

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.

Interventions

DRUGINCS

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Serum Eosinophil Cationic Protein (ECP)	1 month

Secondary

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

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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026