Subcutaneous Immunotherapy in Patients Sensitized to Derm... | NCT01489020

NCT01489020

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

ID	Type	Description	Link
2009-016277-15	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group A active	Experimental	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.	Biological: subcutaneous immunotherapy with DPT extract
Group A placebo	Placebo Comparator	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.	Biological: Subcutaneous depot placebo
group B active	Experimental	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	Biological: subcutaneous immunotherapy with DPT extract
Group B placebo	Placebo Comparator	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	Biological: Subcutaneous depot placebo
Group C active	Experimental	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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
subcutaneous immunotherapy with DPT extract	Biological	Increasing doses of subcutaneous immunotherapy in three different scales up to the maximum dose of 500 TSU (Treatment Standardized Units)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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)

Eligibility Module

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

Name	Affiliation	Role
Mª Dolores Hernández, MD	Hospital Universitario La Fe	Principal Investigator
Ignacio Antépara, MD	Hospital de Basurto	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Hospital de Basurto		Bilbao	Vizcaya	48013	Spain
Hospital La Fe

Arm/Group Information

ID	Title	Description
FG000	Group A Active	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. 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)
FG001	Group A Placebo	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. 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)
FG002	Group B Active	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 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)
FG003	Group B Placebo	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 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)
FG004	Group C Active	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 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)
FG005	Group C Placebo	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 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)

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Group A Active	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. 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) or placebo

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Mean

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

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).

Posted

Number

adverse reactions number

From informed consent signature (V0) until the end of patient participation in the study (depending on the treatment assigned between 4 and 8 weeks )

ID	Title	Description
OG000	Group A Active	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. 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) or placebo

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Group A Active	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. 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) or placebo