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Resolution of Allergic Inflammation

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.
 
ClinicalTrials.gov Identifier: NCT01992835
Recruitment Status : Completed
First Posted : November 25, 2013
Last Update Posted : June 1, 2016
Sponsor:
Information provided by (Responsible Party):
University Hospital, Strasbourg, France

Brief Summary:
After an allergen challenge, the allergic inflammatory response disappears spontaneously. The initiation of the resolution of the inflammatory response is now recognized as a dynamic process, involving active biochemical programs that enable inflamed tissues to return to homeostasis. Recent data established key roles of different specific lipid mediators in the endogenous counter-regulation of inflammation and activation of resolution. Only little is known about kinetics of these specialized pro-resolving lipid mediators during acute allergic inflammation. Therefore, the primary propose of our study is to characterize the temporal evolution of cellular inflammation and specific lipid mediators after allergen challenge.

Condition or disease Intervention/treatment Phase
Grass Pollen Allergic Rhinitis Other: Grass pollen allergen extract Other: placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Official Title: Resolution of Allergic Inflammation: Identification and Kinetics of Specific Lipid Mediators During Nasal Allergen Challenge
Study Start Date : November 2013
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Bee pollen

Arm Intervention/treatment
Placebo Comparator: measurement of mediators in biological fluids Other: placebo
Experimental: Grass pollen allergen extract Other: Grass pollen allergen extract
Each subject will be challenged with a grass pollen allergen extract and with placebo.




Primary Outcome Measures :
  1. Clinical nasal score and measurement of mediators in biological fluids [ Time Frame: Measurement of mediators in biological fluids during 72 h after nasal allergen challenge ]
  2. Clinical nasal score and measurement of mediators in biological fluids. [ Time Frame: Measurement and indentification of specific lipid mediators during nasal allergen challenge ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Eligibility criteria:

Inclusion Criteria

  • Allergic rhinitis during the grass pollen season with or without asthma, with at least one of the following symptoms: nasal congestion, itching, rhinorrhea, sneezing
  • Grass pollen sensitization determined by a positive skin prick test and / or presence of specific IgEs to a grass pollen allergen extract

Exclusion Criteria:

  • Smoker
  • Specific immunotherapy with grass allergens or other respiratory allergen for inclusion.
  • Current exhibition to another clinically relevant respiratory allergen

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): NCT01992835


Locations
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France
Hôpitaux Universitaires
Strasbourg, France, 67091
Sponsors and Collaborators
University Hospital, Strasbourg, France
Investigators
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Principal Investigator: Cindy Barnig Pôle de Pathologie Thoracique- Hôpitaux Universitaires Strasbourg
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Strasbourg, France
ClinicalTrials.gov Identifier: NCT01992835    
Other Study ID Numbers: 5507
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: June 1, 2016
Last Verified: May 2016
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Inflammation
Pathologic Processes
Nose Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases