Phase II Trial With Subcutaneous Immunotherapy in Patients Sensitized to Phleum Pratense
Condition: Allergic Rhinoconjunctivitis
MeSH terms: Conjunctivitis
Intervention: Allergovac Depot; Allergovac Depot; Allergovac Depot; Allergovac Depot; Allergovac Depot; Placebo
Intervention description: Increasing dosages till the maintenance dose of 0.25 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.; Increasing dosages till the maintenance dose of 0.5 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.; Increasing dosages till the maintenance dose of 1SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.; Increasing dosages till the maintenance dose of 2 SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.; Increasing dosages till the maintenance dose of 4SPT is reached. Afterwards, 3 maintenance doses are given at 4-weekly intervals.; Increasing volumes of placebo. Afterwards, 3 maintenance doses are given at 4-weekly intervals.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 151.0
Sex: All
Minimum age: 18 Years
Maximum age: 60 Years
Healthy volunteers: No
Keywords: Allergy; Allergic rhinoconjunctivitis; Subcutaneous Immunotherapy; Phleum pratense pollen extract

Summary:

      Based on EMA (European Medicines Agency) new guidelines on the clinical development of
      products for immunotherapy for the treatment of allergic diseases the aim of this study is to
      establish a dose-response relationship for clinical efficacy of Phleum pratense pollen
      extract subcutaneous vaccine.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients must sign the Informed Consent Form.

          2. Patients must be between 18 and 60 years of age.

          3. Patients with seasonal allergic rhinoconjunctivitis produced by Phleum pratense during
             at least 2 years prior to participating in the study. Although the pathology being
             studied is allergic rhinoconjunctivitis, patients who have concomitant mild or
             moderate asthma may be included.

          4. Patients who have had a skin prick test result equal or more than 3 mm in diameter
             against Phleum pratense.

          5. Patients who have specific IgE equal or more than class 2 (CAP/PHADIA) to Phleum
             pratense.

          6. Patients will preferably be monosensitized to Phleum pratense. Polysensitized patients
             may only be included in the study if their other sensitizations are produced by:

               -  Overlapping seasonal pollens which are cross-reactive with Phleum pratense.

               -  Pollens whose seasons do not overlap with Phleum pratense and which are not
                  expected to produce symptoms during the study period.

               -  Other allergens which are not expected to produce symptoms during the study
                  period.

          7. Women of child-bearing potential must have a negative urine pregnancy test at the time
             they begin the study.

          8. Furthermore, women of child-bearing potential must agree to use adequate contraceptive
             methods during this study if they are sexually active.

        Exclusion Criteria:

          1. Patients with stable and continued use of allergy medication during the 2 weeks prior
             to their inclusion in the study.

          2. Patients sensitized to allergens with overlapping seasons but which are not
             cross-reactive with Phleum pratense and with specific IgE levels equal or less than
             class 2 CAP/PHADIA.

          3. Patients who have received immunotherapy in the 5 years prior to the study against
             either the allergen being tested or an allergen which is cross-reactive, or who are
             currently receiving immunotherapy for any other allergen.

          4. Patients with severe asthma or FEV1 < 70% or with asthma which requires treatment with
             inhaled or systemic corticoids at the time of the study or in the 8 weeks immediately
             prior to the onset of treatment.

          5. Patients with immunological, cardiac, renal or hepatic diseases or any with any other
             illness which the investigators deem may interfere with the study.

          6. Patients with a prior history of anaphylaxis.

          7. Patients with chronic urticaria.

          8. Patients with moderate-severe atopic dermatitis.

          9. Patients with clinically relevant malformations of the upper respiratory tract.

         10. Patients who have participated in another clinical trial within 3 months prior to this
             study.

         11. Patients being treated with tricyclic antidepressants, psychotropic drugs,
             beta-blockers, or angiotensin-converting enzyme inhibitors (ACEIs).

         12. Women who are pregnant or breast-feeding or are of child-bearing age and who do not
             agree to use adequate contraception if they are sexually active and who have not
             demonstrated that they have been surgically sterilized or have other means of not
             bearing children.

         13. Patients who cannot attend study visits.

         14. Patients who are uncooperative or refuse to participate in the study.