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Allergic Inflammation in Rhinitis Patients Following Nasal Allergen Challenge

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01657097
First Posted: August 3, 2012
Last Update Posted: August 6, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
University of Aarhus
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Serum Eosinophil Cationic Protein (ECP) [ Time Frame: 1 month ]

Secondary Outcome Measures:
  • Serum Eosinophil Peroxidase (EPO) [ Time Frame: 1 month ]
  • Nasal lavage Eosinophil Cationic Protein (ECP) [ Time Frame: 1 month ]
  • Nasal lavage Eosinophil Peroxidase (EPO) [ Time Frame: 1 month ]
  • Blood Eosinophils [ Time Frame: 1 month ]

Other Outcome Measures:
  • Bronchial metacholine challenge [ Time Frame: 1 month ]
  • Acoustic rhinometry [ Time Frame: 1 month ]
  • Spirometry (Forced Expiratory Volume 1 second (FEV-1)) [ Time Frame: 1 month ]
  • Nasal symptom score [ Time Frame: 1 month ]
  • Asthma symptom score [ Time Frame: 1 month ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01657097     History of Changes
Other Study ID Numbers: RHINO97
First Submitted: August 1, 2012
First Posted: August 3, 2012
Last Update Posted: August 6, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Inflammation
Rhinitis
Rhinitis, Allergic
Pathologic Processes
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases