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
  Purpose

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.


Condition Intervention Phase
Allergic Rhinoconjunctivitis
Biological: subcutaneous immunotherapy with DPT extract
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Multicentre Phase I Randomized Double Blind Placebo Controlled Study of Subcutaneous Immunotherapy in Subjects With Allergic Rhinoconjunctivitis ± Asthma Sensitised to Dermatophagoides Pteronyssinus.

Resource links provided by NLM:


Further study details as provided by BIAL Industrial Farmacéutica S.A.:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 48
Study Start Date: January 2011
Study Completion Date: August 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)
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 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 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
Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)
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 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 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
Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)
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 immunotherapy with DPT extract
Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01489020

Locations
Spain
Hospital de Basurto
Bilbao, Vizcaya, Spain, 48013
Hospital La Fe
Valencia, Spain, 46009
Sponsors and Collaborators
BIAL Industrial Farmacéutica S.A.
Investigators
Principal Investigator: Mª Dolores Hernández, MD Hospital Universitario La Fe
Principal Investigator: Ignacio Antépara, MD Hospital de Basurto
  More Information

No publications provided

Responsible Party: BIAL Industrial Farmacéutica S.A.
ClinicalTrials.gov Identifier: NCT01489020     History of Changes
Other Study ID Numbers: BIA-DPT-P1-001, 2009-016277-15
Study First Received: December 2, 2011
Last Updated: December 7, 2011
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by BIAL Industrial Farmacéutica S.A.:
Allergy
Immunotherapy
Allergic Rhinoconjunctivitis
D. pteronyssinus
house dust allergy

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctivitis
Conjunctival Diseases
Eye Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on August 28, 2014