Allergic Inflammation in Rhinitis Patients Following Nasal Allergen Challenge
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Feb 1997
Shorter than P25 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 1997
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 1997
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 1997
CompletedFirst Submitted
Initial submission to the registry
August 1, 2012
CompletedFirst Posted
Study publicly available on registry
August 3, 2012
CompletedAugust 6, 2012
August 1, 2012
2 months
August 1, 2012
August 3, 2012
Conditions
Outcome Measures
Primary Outcomes (1)
Serum Eosinophil Cationic Protein (ECP)
1 month
Secondary Outcomes (4)
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 Outcomes (5)
Bronchial metacholine challenge
1 month
Acoustic rhinometry
1 month
Spirometry (Forced Expiratory Volume 1 second (FEV-1))
1 month
- +2 more other outcomes
Study Arms (2)
INCS
EXPERIMENTALFluticasone propionate 400 microgram daily
Placebo
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Aarhuslead
- GlaxoSmithKlinecollaborator
Study Sites (1)
Department of Respiratory Diseases, Aarhus University Hospital
Aarhus, DK-8000 C, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald Dahl, MD
Department of Respiratory Diseases, Aarhus University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 1, 2012
First Posted
August 3, 2012
Study Start
February 1, 1997
Primary Completion
April 1, 1997
Study Completion
April 1, 1997
Last Updated
August 6, 2012
Record last verified: 2012-08