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Allergic Inflammation in Rhinitis Patients Following Nasal Allergen Challenge

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01657097
First received: August 1, 2012
Last updated: August 3, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Allergic Rhinitis
Asthma
 Drug: INCS
Drug: Placebo
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Allergic Inflammation in Rhinitis Patients Following Nasal Allergen Challenge. Impact on Bronchial Hyperresponsiveness and the Effect of Intranasal Corticosteroid Treatment

Resource links provided by NLM:

MedlinePlus related topics: Asthma Steroids
U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Serum Eosinophil Cationic Protein (ECP) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum Eosinophil Peroxidase (EPO) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Nasal lavage Eosinophil Cationic Protein (ECP) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Nasal lavage Eosinophil Peroxidase (EPO) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Blood Eosinophils [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Bronchial metacholine challenge [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Acoustic rhinometry [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Spirometry (Forced Expiratory Volume 1 second (FEV-1)) [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Nasal symptom score [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Asthma symptom score [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 24
Study Start Date: February 1997
Study Completion Date: April 1997
Primary Completion Date: April 1997 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: INCS
Fluticasone propionate 400 microgram daily
 Drug: INCS
Placebo Comparator: Placebo
Placebo
 Drug: Placebo

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01657097

Locations
Denmark
Department of Respiratory Diseases, Aarhus University Hospital
Aarhus, Denmark, DK-8000 C
Sponsors and Collaborators
University of Aarhus
GlaxoSmithKline
Investigators
Principal Investigator: Ronald Dahl, MD Department of Respiratory Diseases, Aarhus University Hospital
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01657097     History of Changes
Other Study ID Numbers: RHINO97
Study First Received: August 1, 2012
Last Updated: August 3, 2012
Health Authority: Denmark: Danish Medicines Agency
Denmark: Danish Dataprotection Agency

Additional relevant MeSH terms:
Asthma
Inflammation
Rhinitis
Bronchial Hyperreactivity
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
 Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Pathologic Processes
Nose Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on May 22, 2013