Subcutaneous Immunotherapy in Patients Sensitized to Phleum Pratense

NCT01489033 | Completed Phase 1

• 2 other identifiers: BIA-PHL-P1-0012009-015000-26
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Allergic Rhinoconjunctivitis

Keywords

Allergic rhinitis; Phleum pratense; Timothy grass pollen allergy; subcutaneous immunotherapy

Outcome Measures

Primary Outcomes (1)

• 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 )

Secondary Outcomes (1)

• 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)

Study Arms (6)

Group A active

EXPERIMENTAL

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

Group A placebo

PLACEBO COMPARATOR

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

Group B active

EXPERIMENTAL

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

Group B placebo

PLACEBO COMPARATOR

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

Group C active

EXPERIMENTAL

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

Group C placebo

PLACEBO COMPARATOR

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

Interventions

Subcutaneous immunotherapy with Phleum pratense pollen extract BIOLOGICAL

Increasing doses up to a maximum dose of 500 TSU

Group A active; Group A placebo; Group B active; Group B placebo; Group C active; Group C placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Roxall Medicina España S.A: lead

Study Sites (1)

Hospital Ramón y Cajal

Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Emilio Álvarez-Cuesta, Md, PhD

  Hospital Universitario Ramon y Cajal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2011
• First Posted: December 9, 2011
• Study Start: January 1, 2010
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 1, 2017

Record last verified: 2017-04

Locations

ES (1)