Subcutaneous Immunotherapy in Patients Sensitized to Dermatophagoides Pteronyssinus (DPT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BIAL Industrial Farmacéutica S.A.
ClinicalTrials.gov Identifier:
NCT01489020
First received: December 2, 2011
Last updated: December 7, 2011
Last verified: December 2011

December 2, 2011
December 7, 2011
January 2011
July 2011   (final data collection date for primary outcome measure)
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 ) ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01489020 on ClinicalTrials.gov Archive Site
Immunoglobulin levels (IgE specific, IgG total and IgG4) and prick test dose response [ Time Frame: Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks) ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Subcutaneous Immunotherapy in Patients Sensitized to Dermatophagoides Pteronyssinus (DPT)
Multicentre Phase I Randomized Double Blind Placebo Controlled Study of Subcutaneous Immunotherapy in Subjects With Allergic Rhinoconjunctivitis ± Asthma Sensitised to Dermatophagoides Pteronyssinus.

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.

Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Allergic Rhinoconjunctivitis
Biological: subcutaneous immunotherapy with DPT extract
Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)
  • 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.
    Intervention: 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.
    Intervention: Biological: subcutaneous immunotherapy with DPT extract
  • 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
    Intervention: 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
    Intervention: Biological: subcutaneous immunotherapy with DPT extract
  • 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
    Intervention: 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
    Intervention: Biological: subcutaneous immunotherapy with DPT extract
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
August 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Patients with allergic rhinoconjunctivitis with or without asthma against DPT during a minimum of 1 year prior to study participation.
  2. Patients must sign the informed consent form.
  3. Patients must be between 18 and 60 years of age.
  4. 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.
  5. 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.
  6. Women of childbearing potential must have a negative urine pregnancy test at Screening visit/Visit 0
  7. Women of childbearing potential must agree to use an appropriate contraception method during the study if they are sexually active

Exclusion Criteria:

  1. Stable and continued use of medication for allergic pathology during 2 weeks prior to inclusion.
  2. Patients sensitised to other perennial allergens clinically relevant and with specific IgE levels greater or equal to class 2 CAP/PHADIA.
  3. 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.
  4. 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.
  5. 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.
  6. Patients with a previous history of anaphylaxis
  7. Patients with chronic urticaria
  8. Patients with unstable angina
  9. Patients with uncontrolled hypertension
  10. Patients with clinically significant arrythmias
  11. Patients with neoplasia
  12. Patients with clinically relevant malformations of the upper respiratory tract.
  13. 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
  14. Patients who have participated in another clinical trial within 3 month prior to enrolment.
  15. Patients under treatment with tricyclic antidepressives, psychotropics beta-blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)
  16. 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
  17. Patient who does not attend the visits
  18. Patient's lack of collaboration or refusal to participate
Both
18 Years to 60 Years
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01489020
BIA-DPT-P1-001, 2009-016277-15
No
BIAL Industrial Farmacéutica S.A.
BIAL Industrial Farmacéutica S.A.
Not Provided
Principal Investigator: Mª Dolores Hernández, MD Hospital Universitario La Fe
Principal Investigator: Ignacio Antépara, MD Hospital de Basurto
BIAL Industrial Farmacéutica S.A.
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP