subcutaneous immunotherapy with DPT extract
BiologicalIncreasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)
Other names: DPT depot vaccine
NCT Number: NCT01489020
Based on EMA (European Medicines Agency) new guidelines on the clinical development of products for immunotherapy for the treatment of allergic diseases the aim of this study was to assess safety and tolerability of 3 different subcutaneous immunotherapy dose escalations in patients allergic to Dermatophagoides pteronyssinus.
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Notify Me18 year–60 year
All sexes
Interventional
Phase 1
Hospital de Basurto, Bilbao, Vizcaya, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)
Other names: DPT depot vaccine
Increasing doses of subcutaneous depot placebo in three different scales
Time frame: From informed consent signature (V0) until the end of patient participation in the study (depending on the treatment assigned between 4 and 8 weeks )
The primary end points were the number of ARs and the severity of local and systemic ARs (SARs) to SCIT administration. Proportions were compared between study arms. The tolerability of SCIT was evaluated by early and late local reactions (i.e., local swelling and redness) and systemic reactions after each injection (any symptoms from organs distant from the location of the injection). Reactions were classified depending on the severity and onset of the reaction, according to the EAACI classification (Alvarez-Cuesta 2006).
Time frame: Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)
Changes on immunoglobulin level determinations (specific IgE, IgG and IgG4) from basal visit to final visit and changes in mean wheal area in prick test dose response from basal visit to final visit, active versus placebo.
Time frame: Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)
Changes on immunoglobulin level determinations (IgG) from basal visit to final visit and changes in mean wheal area in prick test dose response from basal visit to final visit, active versus placebo.
Time frame: Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)
Changes on immunoglobulin level determinations (IgG4) from basal visit to final visit and changes in mean wheal area in prick test dose response from basal visit to final visit, active versus placebo.
Roxall Medicina España S.A
Industry
Multicentre Phase I Randomized Double Blind Placebo Controlled Study of Subcutaneous Immunotherapy in Subjects With Allergic Rhinoconjunctivitis ± Asthma Sensitised to Dermatophagoides Pteronyssinus.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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