Clinical trial NCT01489020: Subcutaneous Immunotherapy in Patients Sensitized to Dermatophagoides Pteronyssinus (DPT)
Official title: Multicentre Phase I Randomized Double Blind Placebo Controlled Study of Subcutaneous Immunotherapy in Subjects With Allergic Rhinoconjunctivitis ± Asthma Sensitised to Dermatophagoides Pteronyssinus.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Allergic Rhinoconjunctivitis
Keywords: Allergy
Immunotherapy
Allergic Rhinoconjunctivitis
D. pteronyssinus
house dust allergy
Lead sponsor: Roxall Medicina España S.A
Sponsor class: INDUSTRY
First posted: 2011-12-09
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Number and Seriousness of Both Local and Systemic Adverse Reactions
timeFrame: 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 outcomes:
measure: Immunoglobulin Levels (IgE Specific) Active Versus Placebo
timeFrame: Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)
measure: Immunoglobulin Levels (IgG Total) Active Versus Placebo
timeFrame: Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)
measure: Immunoglobulin Levels (IgG 4) Active Versus Placebo
timeFrame: Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: Hospital de Basurto
state: Vizcaya
city: Valencia
country: Spain
facility: Hospital La Fe
Study officials:
affiliation: Hospital Universitario La Fe
name: Mª Dolores Hernández, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Basurto
name: Ignacio Antépara, MD
role: PRINCIPAL_INVESTIGATOR
References: