Subcutaneous Immunotherapy in Patients Sensitized to Dermatophagoides Pteronyssinus (DPT)

Allergic Rhinoconjunctivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01489020
• Other study ID #: BIA-DPT-P1-001
• Secondary ID: 2009-016277-15
• Status: Completed
• Phase: Phase 1
• Start date: January 2011
• Est. completion date: August 2011

Study information

• Verified date: January 2019
• Source: Roxall Medicina España S.A
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: August 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Allergic Rhinoconjunctivitis
• Conjunctivitis
• Conjunctivitis, Allergic

Intervention

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)
• Subcutaneous depot placebo
Increasing doses of subcutaneous depot placebo in three different scales

Locations

Country	Name	City	State
Spain	Hospital de Basurto	Bilbao	Vizcaya
Spain	Hospital La Fe	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
Roxall Medicina España S.A

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number and Seriousness of Both Local and Systemic Adverse Reactions	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).	From informed consent signature (V0) until the end of patient participation in the study (depending on the treatment assigned between 4 and 8 weeks )
Secondary	Immunoglobulin Levels (IgE Specific) Active Versus Placebo	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.	Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)
Secondary	Immunoglobulin Levels (IgG Total) Active Versus Placebo	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.	Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)
Secondary	Immunoglobulin Levels (IgG 4) Active Versus Placebo	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.	Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)