Back to resultsSubcutaneous Immunotherapy in Patients Sensitized to Phleum Pratense
Primary Purpose
Allergic Rhinoconjunctivitis
Status
Completed
Phase
Phase 1
Locations
Spain
Study Type
Interventional
Intervention
Subcutaneous immunotherapy with Phleum pratense pollen extract
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinoconjunctivitis focused on measuring Allergic rhinitis, Phleum pratense, Timothy grass pollen allergy, subcutaneous immunotherapy
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.
Sites / Locations
- Hospital Ramón y Cajal
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 dose 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
Secondary Outcome Measures
Immunoglobulin levels (IgE specific, IgG total and IgG4) and prick test dose response
Full Information
NCT ID
NCT01489033
First Posted
December 7, 2011
Last Updated
April 28, 2017
Sponsor
Roxall Medicina España S.A
1. Study Identification
Unique Protocol Identification Number
NCT01489033
Brief Title
Subcutaneous Immunotherapy in Patients Sensitized to Phleum Pratense
Official Title
Multicentre Phase I Randomized Double Blind Placebo Controlled Study of Subcutaneous Immunotherapy in Subjects With Allergic Rhinoconjunctivitis ± Asthma Sensitised to Phleum Pratense.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2010 (Actual)
Study Completion Date
May 2010 (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 disease the aim of this study was to assess safety and tolerability of three different subcutaneous immunotherapy dose escalations in patients allergic to the pollen of Phleum pratense.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinoconjunctivitis
Keywords
Allergic rhinitis, Phleum pratense, Timothy grass pollen allergy, subcutaneous immunotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
42 (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 dose 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 Phleum pratense pollen extract
Intervention Description
Increasing doses up to a maximum dose of 500 TSU
Primary Outcome Measure Information:
Title
Number and seriousness of both local and systemic adverse reactions
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, IgG total and IgG4) and prick test dose response
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 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emilio Álvarez-Cuesta, Md, PhD
Organizational Affiliation
Hospital Universitario Ramon y Cajal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
12. IPD Sharing Statement
Learn more about this trial
Subcutaneous Immunotherapy in Patients Sensitized to Phleum Pratense
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