Allergic patients to the pollen of Phleum pratense with allergic rhino-conjunctivitis with or without mild to moderate asthma. MedDRA version: 16.1 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853
Conditions
Interventions
Product Name: Polymerized Phleum pratense
Product Code: Phl p pol
Pharmaceutical Form: Powder and solvent for suspension for injection
INN or Proposed INN: Polymerized Phleum pratense
Other descriptiv
Sponsors
DIATER, Laboratorio de Diagnóstico y Aplicaciones Terapéuticas, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >=12 and = 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy assessment of Polymerized Phleum pratense inmunotherapy administed intradermally;Secondary Objective: - Efficacy assessment by a combined score of symptoms and medication - Wheal and eritema at the site of administration measurement - Ig E and Ig G levels - Safety assessment;Primary end point(s): Assessment of efficacy of immunotherapy with polymerised Pheum pratense intradermally administered;Timepoint(s) of evaluation of this end point: At the end of the first pollen count season and at the end of the second one. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Assessment of efficacy endpoints other than combined score of symptoms and medicines. Wheal and erythema measure after each treatment cycle . Immunological endpoints (specific IgE and specific IgG4) Assessment of safety of immunotherapy with polymerised Phleum pratense intradermally administered.;Timepoint(s) of evaluation of this end point: At the end of the first pollen count season and at the end of the second one. After each treatment administration. | — |
Countries
Spain
Contacts
Public ContactClinical Trial Department
DIATER Laboratorio de Diagnóstico y Aplicaciones Terapéuticas, S.A.
Outcome results
None listed