Clinical trial NCT02126111: Efficacy of a Depigmented Extract of Phleum in Local Allergic Rhinitis
Official title: Efficacy of a Depigmented Extract of Phleum in the Treatment of Local Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinitis
Lead sponsor: Plaza del Hospital Civil
Sponsor class: OTHER
Collaborators: name: Laboratorios Leti, S.L.
First posted: 2014-04-29
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is evaluate the efficacy of a depigmented grass extract in the treatment of local allergic rhinitis.


Eligibility criteria: Inclusion Criteria:

* Local allergic rhinitis with sensitization to grass pollen
* Skin prick test and serum specific IgE negative to grass pollen.
* Positive Nasal allergen provocation test (NAPT) to grass pollen and/or positive nasal specific IgE to grass pollen.
* Written informed consent

Exclusion Criteria:

* Immunological diseases
* Heart diseases that limit the use of adrenaline. For example, severe hypertension or treatment with beta-blockers.
* Treatment with beta-blockers
* Severe psychological disorders
* Severe atopic dermatitis
* FEV1 \< 70% of reference value after treatment
* Hypersensitivity or intolerance to excipients and / or medication trial.
* Failure to adequately perform diagnostic tests or treatment.
* Sensitization to other allergens (perennial or seasonal) with clinical relevance for the subject and that may interfere in the evaluation of the response.
* Immunotherapy in the 5 years prior to their inclusion in the study.
* Pregnant women or at risk of pregnancy and lactating women.

Primary outcomes:
measure: Symptoms and medication scores comparison between active and placebo group
timeFrame: two years
Secondary outcomes:
measure: Response to nasal allergen provocation test with phleum (NAPT-Phl)
timeFrame: two years
measure: Skin prick-test (SPT) with phleum.
timeFrame: 2 years
measure: Intradermal test (IDT) with phleum
timeFrame: 2 years
measure: FEV1
timeFrame: 2 years
measure: Quality of life questionnaire RQLQ
timeFrame: 2 years
measure: Flow cytometry study for determination of IFN-gamma, IL-13, IL-5, IL-8, IL-10, IL-12, IL-2 in peripheral blood and nasal lavage
timeFrame: 2 years
measure: Determination of tryptase, eosinophil cationic protein, IgG, IgG4, specific IgE to grass (Phl p1, Phl p5, Phl p7, Phl p12) in peripheral blood and nasal lavage.
timeFrame: 2 years
measure: Heart rate
timeFrame: 2 years
measure: Blood pressure
timeFrame: 2 years
measure: Adverse events
timeFrame: 2 years
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Hospital Infanta Leonor
city: Malaga
country: Spain
facility: Hospital Regional Universitario Carlos Haya
Study officials:
affiliation: Hospital Regional Universitario, Málaga, Spain
name: Miguel Blanca, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rondon C, Blanca-Lopez N, Campo P, Mayorga C, Jurado-Escobar R, Torres MJ, Canto G, Blanca M. Specific immunotherapy in local allergic rhinitis: A randomized, double-blind placebo-controlled trial with Phleum pratense subcutaneous allergen immunotherapy. Allergy. 2018 Apr;73(4):905-915. doi: 10.1111/all.13350. Epub 2017 Nov 28.