Efficacy of a Depigmented Extract of Phleum in Local Allergic Rhinitis
NCT ID: NCT02126111
Last Updated: 2016-11-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
56 participants
INTERVENTIONAL
2010-10-31
2016-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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DEPIGOID phleum
The active treatment arm receive active phleum pollen immunotherapy (Depigoid 100% phleum). Depigmented and polymerized allergen extract of Phleum pollen for subcutaneous injection.
DEPIGOID phleum
Subcutaneous Immunotherapy with modified extract of Phleum pollen.
DEPIGOID Placebo & DEPIGOID Phleum
This arm receive DEPIGOID Placebo during the first year, and DEPIGOID Phleum during the second year of study.
DEPIGOID Placebo contains the same composition as in the active DEPIGOID Phleum with the only difference being the exclusion of the phleum pollen allergen extract.
DEPIGOID phleum
Subcutaneous Immunotherapy with modified extract of Phleum pollen.
DEPIGOID Placebo
Placebo for subcutaneous administration
Interventions
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DEPIGOID phleum
Subcutaneous Immunotherapy with modified extract of Phleum pollen.
DEPIGOID Placebo
Placebo for subcutaneous administration
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
55 Years
ALL
No
Sponsors
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Laboratorios Leti, S.L.
INDUSTRY
Plaza del Hospital Civil
OTHER
Responsible Party
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Miguel Blanca Gomez
Director Allergy Unit
Principal Investigators
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Miguel Blanca, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Regional Universitario, Málaga, Spain
Locations
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Hospital Infanta Leonor
Madrid, Madrid, Spain
Hospital Regional Universitario Carlos Haya
Málaga, Malaga, Spain
Countries
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References
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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.
Other Identifiers
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MBG6043179
Identifier Type: -
Identifier Source: org_study_id