Subcutaneous Immunotherapy in Patients Sensitized to Dermatophagoides Pteronyssinus (DPT)

Phase 1

Completed

Conditions: Allergic Rhinoconjunctivitis

Interventions: Biological: Subcutaneous depot placebo
Biological: subcutaneous immunotherapy with DPT extract

Registration Number: NCT01489020

Lead Sponsor: Roxall Medicina España S.A

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 48

Inclusion Criteria

Patients with allergic rhinoconjunctivitis with or without asthma against DPT during a minimum of 1 year prior to study participation.
Patients must sign the informed consent form.
Patients must be between 18 and 60 years of age.
Patients who obtained a prick test result greater or equal to 3 mm diameter and a specific IgE greater or equal to class 2 (CAP/PHADIA) to DPT.
Patients will preferably be monosensitized to DPT. In the case of polysensitized patients they can only be included if other sensitizations are caused by seasonal allergens whose pollination do not overlap with the study period.
Women of childbearing potential must have a negative urine pregnancy test at Screening visit/Visit 0
Women of childbearing potential must agree to use an appropriate contraception method during the study if they are sexually active

Exclusion Criteria

Stable and continued use of medication for allergic pathology during 2 weeks prior to inclusion.
Patients sensitised to other perennial allergens clinically relevant and with specific IgE levels greater or equal to class 2 CAP/PHADIA.
Patients who received immunotherapy in the previous 5 years for DPT or for any allergen with cross reactivity or patients that are currently receiving immunotherapy for any allergen.
Patients with severe asthma or FEV1 minor than 70% or asthma requiring inhaled or systemic corticoid treatment at the time of study entry or within 8 weeks prior to treatment initiation.
Patients with: immunological, cardiac, renal or hepatic illnesses or any other medical condition that the investigator deems relevant so as to interfere with the study.
Patients with a previous history of anaphylaxis
Patients with chronic urticaria
Patients with unstable angina
Patients with uncontrolled hypertension
Patients with clinically significant arrythmias
Patients with neoplasia
Patients with clinically relevant malformations of the upper respiratory tract.
Other chronic or immunological disease that could interfere with the assessment of the investigational product or that could generate any additional risk for the patients
Patients who have participated in another clinical trial within 3 month prior to enrolment.
Patients under treatment with tricyclic antidepressives, psychotropics beta-blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)
Female patients who are pregnant or breast-feeding or women of childbearing potential that do not agree to use an appropriate contraception method during the study if they are sexually active, if they have not been surgically sterilised or present any other incapacity to bear
Patient who does not attend the visits
Patient's lack of collaboration or refusal to participate

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A placebo	Subcutaneous depot 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.
Group A active	subcutaneous immunotherapy with DPT extract	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.
group B active	subcutaneous immunotherapy with DPT extract	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
Group C active	subcutaneous immunotherapy with DPT extract	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
Group C placebo	Subcutaneous depot 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
Group B placebo	Subcutaneous depot 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

Primary Outcome Measures

Name	Time	Method
Number and Seriousness of Both Local and Systemic Adverse Reactions	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).

Secondary Outcome Measures

Name	Time	Method
Immunoglobulin Levels (IgE Specific) Active Versus Placebo	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.
Immunoglobulin Levels (IgG 4) Active Versus Placebo	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.
Immunoglobulin Levels (IgG Total) Active Versus Placebo	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.