Multicenter, randomized, parallel-group, double-blind, placebo-controlled clinical trial for evaluating the clinical efficacy and safety of intradermal immunotherapy with polimerised Phleum pratense, in patients with allergic rhino-conjunctivitis with or without mild to moderate asthma, sensitised to Phleum pratense pollen.

DIATER, Laboratorio de Diagnóstico y Aplicaciones Terapéuticas, S.A.0 sites174 target enrollmentStarted: March 6, 2014Last updated: December 4, 2018

Conditions

Trial Snapshot

No summary available.

•1. Age >=12 and <=50 years old
•2. Patients that signed the informed consent to participate in the study
•3. Allergic patients to Phleum pratense:
•- Specific Ig E to Phleum pratense and or Phl p 1 >= 3.5 KU/L (CAP)
•- Positive prick test to Phleum pratense, considering positive a wheal >= 3 mm with respect to the negative control
•4. Patients with rinitis or rhinoconjunctivitis with or without mild to moderate ashtma in the last two years.
•5. Patients able to fulfill the treatment
•6. Women able to get pregnant should present a negative pregnancy test in the previous 7 days before the start of the trial, and use anticonceptive methods.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 40
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 134
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1. Patients with concomitant inmune diseases that could interfere with the clinical trial, as investigator discretion
•2. Severe exacerbation of asthma that requires hospitalization, or FEV1<70%
•3. Polisensitized patients to relevant allergens that could interfere with clinical trial.
•4. Patients that received inmunotherapy against Gramineae in the last 5 years
•5. Patients with uncontrolled moderate or severe ashtma
•6. Malign diseases
•7. Patients in which adrenaline administration is contraindicated.
•8. Allergic patient to manitol.
•9. Patients with active tuberculosis.
•10. Patients with severe atopic eczema
•11. Patients with dermographism or skin pathologies that could interfere with the assessment of prick test.
•12. Psiquiatric alterations that unable the patient to fulfill with the treatment.
•13. Patients treated with betablockers or IECA
•14. Patients unable to fulfill the inmunotherapy treatment
•15. Preagnant or breastfeeding women.
•16. Fertile women that do not compromise to use anticonceptive methods.
•17. Patients enrolled in other clinical trials
•18. Patients of any disease that alter absorption or excretion of medicaments
•19. Chronic alcohol or drugs consumption

Sponsor

DIATER, Laboratorio de Diagnóstico y Aplicaciones Terapéuticas, S.A.