Subcutaneous Immunotherapy in Patients Sensitized to Dermatophagoides Pteronyssinus (DPT)

Browse trials for

• Conjunctivitis 361
• Conjunctivitis, Allergic 226

Keywords

• Allergy
• Immunotherapy
• Allergic Rhinoconjunctivitis
• D. pteronyssinus
• house dust allergy

Conjunctivitis

361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.

This study's enrollment of 48 is below the median of 100 across 299 interventional studies indexed under Conjunctivitis.

Lead sponsor

Roxall Medicina España S.A is the lead sponsor of 15 studies on the registry; none are open to participants now.

Study arms

• Experimental
  Group A active

  6 administrations and 5 weeks duration 1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals 2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.

  Biological: subcutaneous immunotherapy with DPT extract

• Placebo comparator
  Group A placebo

  6 administrations and 5 weeks duration 1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals 2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.

  Biological: Subcutaneous depot placebo

• Experimental
  group B active

  8 administrations and 7 weeks duration 1. Vial 1: 0.2 ml at 1 week intervals 2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals 3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals

  Biological: subcutaneous immunotherapy with DPT extract

• Placebo comparator
  Group B placebo

  8 administrations and 7 weeks duration 1. Vial 1: 0.2 ml at 1 week intervals 2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals 3. Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals

  Biological: Subcutaneous depot placebo

• Experimental
  Group C active

  8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks. 1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval 2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval 3. Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval 4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval

  Biological: subcutaneous immunotherapy with DPT extract

• Placebo comparator
  Group C placebo

  8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks. 1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval 2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval 3. Week 3: vial 3 - 2 dose of 0.1 ml with 30 minute interval 4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval

  Biological: Subcutaneous depot placebo

Interventions

• Biologicalsubcutaneous immunotherapy with DPT extract

  Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)

  Also known as: DPT depot vaccine

• BiologicalSubcutaneous depot placebo

  Increasing doses of subcutaneous depot placebo in three different scales

Primary outcomes

1. Number and Seriousness of Both Local and Systemic Adverse Reactions

   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: From informed consent signature (V0) until the end of patient participation in the study (depending on the treatment assigned between 4 and 8 weeks )

Secondary outcomes

1. Immunoglobulin Levels (IgE Specific) Active Versus Placebo

   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)

2. Immunoglobulin Levels (IgG Total) Active Versus Placebo

   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)

3. Immunoglobulin Levels (IgG 4) Active Versus Placebo

   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.

   Time frame: Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)

Baseline characteristics