A Phase 2 interventional study of DEPIGOID phleum and DEPIGOID Placebo in Allergic Rhinitis, sponsored by Plaza del Hospital Civil. Completed at 2 sites in Spain. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2016-11-08.
Sponsored by Plaza del Hospital Civil · Phase 2, Interventional, and Treatment
The purpose of this study is evaluate the efficacy of a depigmented grass extract in the treatment of local allergic rhinitis.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 56 is below the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →This is the only study on the registry with Plaza del Hospital Civil as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The active treatment arm receive active phleum pollen immunotherapy (Depigoid 100% phleum). Depigmented and polymerized allergen extract of Phleum pollen for subcutaneous injection.
Biological: 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.
Biological: DEPIGOID phleum · Biological: DEPIGOID Placebo
Subcutaneous Immunotherapy with modified extract of Phleum pollen.
Placebo for subcutaneous administration
Symptoms and medication scores comparison between active and placebo group
Patients were provided a diary to score the severity of their symptoms and the use of rescue medication during 4 weeks in two consecutive springs. Nasal symptoms of rhinorrhea, nasal congestion, sneezing, nasal itching, and ocular symptoms were recorded using a 4-point categorical scale from 0 to 3 (0: no symptoms, 1:mild, 2:moderate; 3:severe). The use of rescue medication was recorded in the patient diary according to the following score: Oral antihistamines (1 tablet = 1 point); intranasal corticosteroids (400mcg/day of beclometasone or equivalent = 1.4 points); and ocular antihistamines (1 dose = 1 point).
Time frame: two years
Response to nasal allergen provocation test with phleum (NAPT-Phl)
The response to NAPT-Phl with increasing concentrations of phleum pratense (0.001-0.01-0.05-0.1 mcg/ml) will be evaluated by nasal symptoms and acoustic rhinometry.
Time frame: two years
Skin prick-test (SPT) with phleum.
Evaluation of SPT wheal size.
Time frame: 2 years
Intradermal test (IDT) with phleum
IDT wheal and erythema size.
Time frame: 2 years
FEV1
Time frame: 2 years
Quality of life questionnaire RQLQ
Time frame: 2 years
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
Time frame: 2 years
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.
Time frame: 2 years
Heart rate
Time frame: 2 years
Blood pressure
Time frame: 2 years
Adverse events
Time frame: 2 years
Plan to share: No
This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.
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