Subcutaneous Immunotherapy in Patients Sensitized to Dermatophagoides Pteronyssinus (DPT)

NCT ID: NCT01489020

Last Updated: 2019-05-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2011-08-31

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.

Conditions

Allergic Rhinoconjunctivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

subcutaneous immunotherapy with DPT extract

Intervention Type: BIOLOGICAL

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

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.

Group Type: PLACEBO_COMPARATOR

Subcutaneous depot placebo

Intervention Type: BIOLOGICAL

Increasing doses of subcutaneous depot placebo in three different scales

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

Group Type: EXPERIMENTAL

subcutaneous immunotherapy with DPT extract

Intervention Type: BIOLOGICAL

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

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

Group Type: PLACEBO_COMPARATOR

Subcutaneous depot placebo

Intervention Type: BIOLOGICAL

Increasing doses of subcutaneous depot placebo in three different scales

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

Group Type: EXPERIMENTAL

subcutaneous immunotherapy with DPT extract

Intervention Type: BIOLOGICAL

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

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

Group Type: PLACEBO_COMPARATOR

Subcutaneous depot placebo

Intervention Type: BIOLOGICAL

Increasing doses of subcutaneous depot placebo in three different scales

Interventions

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)

Intervention Type: BIOLOGICAL

Subcutaneous depot placebo

Increasing doses of subcutaneous depot placebo in three different scales

Intervention Type: BIOLOGICAL

Other Intervention Names

DPT depot vaccine

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roxall Medicina España S.A

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mª Dolores Hernández, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Fe

Ignacio Antépara, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Basurto

Locations

Hospital de Basurto

Bilbao, Vizcaya, Spain

Hospital La Fe

Valencia, , Spain

Countries

Spain

Other Identifiers

2009-016277-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BIA-DPT-P1-001

Identifier Type: -

Identifier Source: org_study_id