Subcutaneous Immunotherapy in Patients Sensitized to Phle... | NCT01489033

NCT01489033

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

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
2009-015000-26	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 Phleum pratense pollen 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 immunotherapy with Phleum pratense pollen extract
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 Phleum pratense pollen 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 immunotherapy with Phleum pratense pollen extract
Group C active	Experimental

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Subcutaneous immunotherapy with Phleum pratense pollen extract	Biological	Increasing doses up to a maximum dose of 500 TSU	Group A active Group A placebo

Measure	Description	Time Frame
Number and seriousness of both local and systemic adverse reactions		From informed consent signature (V0) until the end of patient participation in the study (depending on the treatment assigned between 4 and 8 weeks )

Measure	Description	Time Frame
Immunoglobulin levels (IgE specific, IgG total and IgG4) and prick test dose response		Before (V0) and after treatment (depending on the treatment assigned between 4 and 8 weeks)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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 Phleum pratense.
Patients with seasonal allergic rhinoconjunctivitis against Phleum pratense during a minimum of 2 years prior to study participation. Although allergic rhinoconjunctivitis is the pathology under study, the inclusion of patients with mild or moderate concomitant asthma is allowed.
Patients will preferably be monosensitized to Phleum pratense. Polysensitized patients to other seasonal allergens will be accepted if sensitizations are caused by Pollens whose seasons do not overlap with Phleum pratense.

Polysensitized patients to perennial allergens will also be accepted if not clinically relevant during 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 overlapping seasonal allergens and with specific IgE levels greater or equal to class 2 CAP/PHADIA.
Patients who received immunotherapy in the previous 5 years for Phleum pratense or for any allergen with cross reactivity or patients that are currently receiving immunotherapy for any allergen.
Patients with severe asthma or FEV1 lower than 60% or asthma requiring inhaled or systemic corticoid treatment at the time of study entry or within 8 weeks prior to treatment commencement.
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 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 investigation product or that could generate any additional risk for the patient
Patients who have participated in another clinical trial within 3 month prior to enrolment.
Patients under treatment with tricyclic antidepressives, psychotropics or beta-blockers
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 surgical sterilised or present any other incapacity to bear
Patient who does not attend the visits
Patient's lack of collaboration or refusal to participate.

ID	Term
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity