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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT01567306 |
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Date of registration:
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23/03/2012 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Phase II Trial With Subcutaneous Immunotherapy in Patients Sensitized to Phleum Pratense
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Scientific title:
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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 |
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Date of first enrolment:
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October 2011 |
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Target sample size:
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151 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01567306 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
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Phase:
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Phase 2
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Countries of recruitment
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Portugal
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Spain
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Contacts
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Name:
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Filipe Inácio, MD |
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Address:
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Email:
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Affiliation:
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Centro Hospitalar de Setúbal - Hospital de São Bernardo |
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Name:
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Santiago Quirce, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Universitario La Paz |
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Name:
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José Alberto Ferreira, MD |
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Address:
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Email:
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Affiliation:
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Centro Hospitalar Gaia/Espinho |
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Name:
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Matilde Rodríguez, MD |
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Address:
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Email:
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Affiliation:
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Hospital Universitario Puerta de Hierro |
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Name:
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Celso Pereira, MD |
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Address:
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Email:
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Affiliation:
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Hospital da Universidade de Coimbra |
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Name:
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José Luís Plácido, MD |
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Address:
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Email:
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Affiliation:
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Centro Hospitalar de S. João |
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Name:
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Carmen Panizo, MD |
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Address:
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Email:
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Affiliation:
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Hospital Ntra. Sra. del Prado |
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Name:
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José Manuel Zubeldia, MD |
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Address:
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Telephone:
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Affiliation:
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Hospital Universitario Gregorio Marañón |
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Name:
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Emilio Alvarez Cuesta, MD |
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Address:
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Email:
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Affiliation:
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Hospital Universitario Ramón y Cajal |
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Name:
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João Fonseca, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Instituto CUF Porto |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
60 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Allergic Rhinoconjunctivitis
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Intervention(s)
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Biological: Placebo
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Biological: Allergovac Depot
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Primary Outcome(s)
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Variation of the Concentration of Phleum Pratense Extract Needed to Produce a Positive Nasal Provocation Test From Baseline (V0) to Final Visit (FV).
[Time Frame: 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.]
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Secondary Outcome(s)
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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.
[Time Frame: 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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Secondary ID(s)
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BIA-PHL-P2-001
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2011-000814-21
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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