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Completed

NCT Number: NCT01489020

Subcutaneous Immunotherapy in Patients Sensitized to Dermatophagoides Pteronyssinus (DPT)

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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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Hospital de Basurto, Bilbao, Vizcaya, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

subcutaneous immunotherapy with DPT extract

Biological

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

Subcutaneous depot placebo

Biological

Increasing doses of subcutaneous depot placebo in three different scales

Primary outcomes

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

    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).

Secondary outcomes

  1. Immunoglobulin Levels (IgE Specific) 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 (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.

  2. Immunoglobulin Levels (IgG Total) 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.

  3. Immunoglobulin Levels (IgG 4) 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.

Sponsors and collaborators

Lead sponsor

Roxall Medicina España S.A

Industry

Registry information

Official study title

Multicentre Phase I Randomized Double Blind Placebo Controlled Study of Subcutaneous Immunotherapy in Subjects With Allergic Rhinoconjunctivitis ± Asthma Sensitised to Dermatophagoides Pteronyssinus.

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Dec 9, 2011
Registry last updated
May 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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