Allergic Inflammation in Rhinitis Patients Following Nasal Allergen Challenge

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01657097
• Other study ID #: RHINO97
• Status: Completed
• Phase: Phase 4
• First received: August 1, 2012
• Last updated: August 3, 2012
• Start date: February 1997
• Est. completion date: April 1997

Study information

• Verified date: August 2012
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyDenmark: Danish Dataprotection Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: April 1997
• Est. primary completion date: April 1997
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Allergic Rhinitis
• Asthma
• Rhinitis

Intervention

Drug:
• INCS

• Placebo

Locations

Country	Name	City	State
Denmark	Department of Respiratory Diseases, Aarhus University Hospital	Aarhus

Sponsors (2)

Lead Sponsor	Collaborator
University of Aarhus	GlaxoSmithKline

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Bronchial metacholine challenge		1 month	No
Other	Acoustic rhinometry		1 month	No
Other	Spirometry (Forced Expiratory Volume 1 second (FEV-1))		1 month	No
Other	Nasal symptom score		1 month	No
Other	Asthma symptom score		1 month	No
Primary	Serum Eosinophil Cationic Protein (ECP)		1 month	No
Secondary	Serum Eosinophil Peroxidase (EPO)		1 month	No
Secondary	Nasal lavage Eosinophil Cationic Protein (ECP)		1 month	No
Secondary	Nasal lavage Eosinophil Peroxidase (EPO)		1 month	No
Secondary	Blood Eosinophils		1 month	No