Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01992835
Other study ID # 5507
Secondary ID
Status Completed
Phase N/A
First received October 24, 2013
Last updated May 31, 2016
Start date November 2013
Est. completion date April 2014

Study information

Verified date May 2016
Source University Hospital, Strasbourg, France
Contact n/a
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 55 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject)


Related Conditions & MeSH terms


Intervention

Other:
Grass pollen allergen extract
Each subject will be challenged with a grass pollen allergen extract and with placebo.
placebo


Locations

Country Name City State
France Hôpitaux Universitaires Strasbourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical nasal score and measurement of mediators in biological fluids Measurement of mediators in biological fluids during 72 h after nasal allergen challenge No
Primary Clinical nasal score and measurement of mediators in biological fluids. Measurement and indentification of specific lipid mediators during nasal allergen challenge