Back to resultsSubcutaneous Immunotherapy in Patients Sensitized to Dermatophagoides Pteronyssinus (DPT)
Primary Purpose
Allergic Rhinoconjunctivitis
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
subcutaneous immunotherapy with DPT extract
Subcutaneous depot placebo
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinoconjunctivitis focused on measuring Allergy, Immunotherapy, Allergic Rhinoconjunctivitis, D. pteronyssinus, house dust allergy
Eligibility Criteria
Inclusion Criteria:
- Patients with allergic rhinoconjunctivitis with or without asthma against DPT during a minimum of 1 year prior to study participation.
- Patients must sign the informed consent form.
- Patients must be between 18 and 60 years of age.
- 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.
- 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.
- Women of childbearing potential must have a negative urine pregnancy test at Screening visit/Visit 0
- Women of childbearing potential must agree to use an appropriate contraception method during the study if they are sexually active
Exclusion Criteria:
- Stable and continued use of medication for allergic pathology during 2 weeks prior to inclusion.
- Patients sensitised to other perennial allergens clinically relevant and with specific IgE levels greater or equal to class 2 CAP/PHADIA.
- 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.
- 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.
- 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.
- Patients with a previous history of anaphylaxis
- Patients with chronic urticaria
- Patients with unstable angina
- Patients with uncontrolled hypertension
- Patients with clinically significant arrythmias
- Patients with neoplasia
- Patients with clinically relevant malformations of the upper respiratory tract.
- 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
- Patients who have participated in another clinical trial within 3 month prior to enrolment.
- Patients under treatment with tricyclic antidepressives, psychotropics beta-blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)
- 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
- Patient who does not attend the visits
- Patient's lack of collaboration or refusal to participate
Sites / Locations
- Hospital de Basurto
- Hospital La Fe
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
Group A active
Group A placebo
group B active
Group B placebo
Group C active
Group C placebo
Arm Description
6 administrations and 5 weeks duration Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.
6 administrations and 5 weeks duration Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.
8 administrations and 7 weeks duration Vial 1: 0.2 ml at 1 week intervals Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals
8 administrations and 7 weeks duration Vial 1: 0.2 ml at 1 week intervals Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals
8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval
8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval Week 3: vial 3 - 2 dose of 0.1 ml with 30 minute interval Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT01489020
First Posted
December 2, 2011
Last Updated
January 29, 2019
Sponsor
Roxall Medicina España S.A
1. Study Identification
Unique Protocol Identification Number
NCT01489020
Brief Title
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
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Roxall Medicina España S.A
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinoconjunctivitis
Keywords
Allergy, Immunotherapy, Allergic Rhinoconjunctivitis, D. pteronyssinus, house dust allergy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A active
Arm Type
Experimental
Arm Description
6 administrations and 5 weeks duration
Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.
Arm Title
Group A placebo
Arm Type
Placebo Comparator
Arm Description
6 administrations and 5 weeks duration
Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.
Arm Title
group B active
Arm Type
Experimental
Arm Description
8 administrations and 7 weeks duration
Vial 1: 0.2 ml at 1 week intervals
Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals
Arm Title
Group B placebo
Arm Type
Placebo Comparator
Arm Description
8 administrations and 7 weeks duration
Vial 1: 0.2 ml at 1 week intervals
Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
Vial 3: 0.1 ml, 0.2 ml, 0.4 ml and 0.5 ml at 1 week intervals
Arm Title
Group C active
Arm Type
Experimental
Arm Description
8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.
Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
Week 3: vial 3 - 2 doses of 0.1 ml with 30 minute interval
Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval
Arm Title
Group C placebo
Arm Type
Placebo Comparator
Arm Description
8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.
Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
Week 3: vial 3 - 2 dose of 0.1 ml with 30 minute interval
Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval
Intervention Type
Biological
Intervention Name(s)
subcutaneous immunotherapy with DPT extract
Other Intervention Name(s)
DPT depot vaccine
Intervention Description
Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)
Intervention Type
Biological
Intervention Name(s)
Subcutaneous depot placebo
Intervention Description
Increasing doses of subcutaneous depot placebo in three different scales
Primary Outcome Measure Information:
Title
Number and Seriousness of Both Local and Systemic Adverse Reactions
Description
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).
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 )
Secondary Outcome Measure Information:
Title
Immunoglobulin Levels (IgE Specific) Active Versus Placebo
Description
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.
Time Frame
Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)
Title
Immunoglobulin Levels (IgG Total) Active Versus Placebo
Description
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.
Time Frame
Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)
Title
Immunoglobulin Levels (IgG 4) Active Versus Placebo
Description
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.
Time Frame
Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with allergic rhinoconjunctivitis with or without asthma against DPT during a minimum of 1 year prior to study participation.
Patients must sign the informed consent form.
Patients must be between 18 and 60 years of age.
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.
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.
Women of childbearing potential must have a negative urine pregnancy test at Screening visit/Visit 0
Women of childbearing potential must agree to use an appropriate contraception method during the study if they are sexually active
Exclusion Criteria:
Stable and continued use of medication for allergic pathology during 2 weeks prior to inclusion.
Patients sensitised to other perennial allergens clinically relevant and with specific IgE levels greater or equal to class 2 CAP/PHADIA.
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.
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.
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.
Patients with a previous history of anaphylaxis
Patients with chronic urticaria
Patients with unstable angina
Patients with uncontrolled hypertension
Patients with clinically significant arrythmias
Patients with neoplasia
Patients with clinically relevant malformations of the upper respiratory tract.
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
Patients who have participated in another clinical trial within 3 month prior to enrolment.
Patients under treatment with tricyclic antidepressives, psychotropics beta-blockers, or Angiotensin Converting Enzyme Inhibitors (ACEI)
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
Patient who does not attend the visits
Patient's lack of collaboration or refusal to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mª Dolores Hernández, MD
Organizational Affiliation
Hospital Universitario La Fe
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ignacio Antépara, MD
Organizational Affiliation
Hospital de Basurto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Basurto
City
Bilbao
State/Province
Vizcaya
ZIP/Postal Code
48013
Country
Spain
Facility Name
Hospital La Fe
City
Valencia
ZIP/Postal Code
46009
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Subcutaneous Immunotherapy in Patients Sensitized to Dermatophagoides Pteronyssinus (DPT)
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