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Subcutaneous Immunotherapy in Patients Sensitized to Phleum Pratense

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BIAL Industrial Farmacéutica S.A.
ClinicalTrials.gov Identifier:
NCT01489033
First received: December 7, 2011
Last updated: December 8, 2011
Last verified: December 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Allergic Rhinoconjunctivitis
 Biological: Subcutaneous immunotherapy with Phleum pratense pollen extract
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Multicentre Phase I Randomized Double Blind Placebo Controlled Study of Subcutaneous Immunotherapy in Subjects With Allergic Rhinoconjunctivitis ± Asthma Sensitised to Phleum Pratense.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by BIAL Industrial Farmacéutica S.A.:

Primary Outcome Measures:
  • 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 ) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: January 2010
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A active

6 administrations and 5 weeks duration

  1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
  2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.
 Biological: Subcutaneous immunotherapy with Phleum pratense pollen extract
Increasing doses up to a maximum dose of 500 TSU
Placebo Comparator: Group A placebo

6 administrations and 5 weeks duration

  1. Vial 2: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals
  2. Vial 3: 0.1 ml, 0.2 ml and 0.5 ml at 1 week intervals.
 Biological: Subcutaneous immunotherapy with Phleum pratense pollen extract
Increasing doses up to a maximum dose of 500 TSU
Experimental: Group B active

8 administrations and 7 weeks duration

  1. Vial 1: 0.2 ml at 1 week intervals
  2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
  3. 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
Increasing doses up to a maximum dose of 500 TSU
Placebo Comparator: Group B placebo

8 administrations and 7 weeks duration

  1. Vial 1: 0.2 ml at 1 week intervals
  2. Vial 2: 0.1 ml, 0.2 ml, 0.4 ml at 1 week intervals
  3. 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
Increasing doses up to a maximum dose of 500 TSU
Experimental: Group C active

8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.

  1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
  2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
  3. Week 3: vial 3 - 2 dose of 0.1 ml with 30 minute interval
  4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval
 Biological: Subcutaneous immunotherapy with Phleum pratense pollen extract
Increasing doses up to a maximum dose of 500 TSU
Placebo Comparator: Group C placebo

8 administrations, 2 administrations in the same day. 1 week interval between 2 doses, during 3 weeks.

  1. Week 1: vial 2 - 2 administrations of 0.1 ml with 30 minute interval
  2. Week 2: vial 2 - 0.2 ml and 0.3 ml with 30 minute interval
  3. Week 3: vial 3 - 2 dose of 0.1 ml with 30 minute interval
  4. Week 4: vial 3 - 0.2 ml and 0.3 ml with 30 minute interval
 Biological: Subcutaneous immunotherapy with Phleum pratense pollen extract
Increasing doses up to a maximum dose of 500 TSU

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients must sign the informed consent form.
  2. Patients must be between 18 and 60 years of age.
  3. 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.
  4. 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.

  5. 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.

  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 overlapping seasonal allergens and with specific IgE levels greater or equal to class 2 CAP/PHADIA.
  3. 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.
  4. 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.
  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 unstable angina
  8. Patients with uncontrolled hypertension
  9. Patients with clinically significant arrythmias
  10. Patients with neoplasia
  11. Patients with clinically relevant malformations of the upper respiratory tract.
  12. 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
  13. Patients who have participated in another clinical trial within 3 month prior to enrolment.
  14. Patients under treatment with tricyclic antidepressives, psychotropics or beta-blockers
  15. 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
  16. Patient who does not attend the visits
  17. Patient's lack of collaboration or refusal to participate.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01489033

Locations
Spain
Hospital Ramón y Cajal
Madrid, Spain, 28034
Sponsors and Collaborators
BIAL Industrial Farmacéutica S.A.
Investigators
Principal Investigator: Emilio Álvarez-Cuesta, Md, PhD Hospital Ramón y Cajal
  More Information

No publications provided

Responsible Party: BIAL Industrial Farmacéutica S.A.
ClinicalTrials.gov Identifier: NCT01489033     History of Changes
Other Study ID Numbers: BIA-PHL-P1-001, 2009-015000-26
Study First Received: December 7, 2011
Last Updated: December 8, 2011
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by BIAL Industrial Farmacéutica S.A.:
Allergic rhinitis
Phleum pratense
Timothy grass pollen allergy
subcutaneous immunotherapy

Additional relevant MeSH terms:
Conjunctivitis, Allergic
Conjunctivitis
Conjunctival Diseases
Eye Diseases
 Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 16, 2013