Allergic Rhinoconjunctivitis Clinical Trial
Official title:
Phase II, Multicenter, Randomized, Double Blind Study, With Subcutaneous Immunotherapy At Different Doses, in Parallel Groups and Placebo-Controlled, in Patients With Rhinoconjunctivitis ± Asthma Sensitized to Phleum Pratense
Verified date | January 2019 |
Source | Roxall Medicina España S.A |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 151 |
Est. completion date | April 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 60 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
Portugal | Hospital da Universidade de Coimbra | Coimbra | |
Portugal | Centro Hospitalar de S. João | Porto | |
Portugal | Instituto CUF Porto | Senhora da Hora | |
Portugal | Centro Hospitalar de Setúbal - Hospital de São Bernardo | Setúbal | |
Portugal | Centro Hospitalar Gaia/Espinho | Vila Nova de Gaia | |
Spain | Hospital Universitario Gregorio Marañón | Madrid | |
Spain | Hospital Universitario La Paz | Madrid | |
Spain | Hospital Universitario Puerta de Hierro | Madrid | |
Spain | Hospital Universitario Ramón y Cajal | Madrid | |
Spain | Hospital Ntra. Sra. del Prado | Talavera de la Reina | Toledo |
Lead Sponsor | Collaborator |
---|---|
Roxall Medicina España S.A |
Portugal, Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Variation of the Concentration of Phleum Pratense Extract Needed to Produce a Positive Nasal Provocation Test From Baseline (V0) to Final Visit (FV). | Variation of the concentration of Phleum pratense extract needed to produce a positive nasal provocation test from baseline (V0) to final visit (FV). The changes will be compared among groups (including the placebo group). | Baseline (V0) and Final Visit (FV). The Final Visit will be conducted within 7 plus minus 2 days after the last dose is administered. The study will be carried out outside the pollination season of Phleum pratense. | |
Secondary | All Adverse Reactions and or Events Will be Recorded Both by the Patient and the Health Care Personnel Responsible for the Administration of the Subcutaneous Immunotherapy. | All adverse reactions and/or events were recorded both by the patient and the health care personnel responsible for the administration of the subcutaneous immunotherapy. The incidence and intensity of adverse events was compared among the treatment groups. | From baseline (V0) to final visit (VF). The Final Visit will be conducted within 7 plus minus 2 days after the last dose is administered. All AE should be monitored until they are satisfactorily resolved or stabilized after the final visit of the study |
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