Allergic rhinitis / rhinoconjunctivitis and/or mild or moderate allergic asthma to grass pollen, tree pollen or mites.
Conditions
Interventions
Trade Name: ALUSTAL
Product Name: ALUSTAL
Pharmaceutical Form: Solution for injection
INN or Proposed INN: dactylis glomerata, lolium perenne y phleum pratense+polen de olivo 50%+ácaros o gramíneas 50
Sponsors
STALLERGENES
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-45 with allergic rhinitis/ rhinoconjunctivitis and/or mild or moderate allergic asthma. 2. Clinical sensitisation to mites (Dermatophagoides pteronyssinus and/or Dermatophagoides farinae), grass pollen, olive+grass pollen or mites. 3. Positive clinical history of mites or grass pollen, olive+grass pollen, proven by: - the majority of clinical symptoms appearing during the appropiate seasons for mites, grass pollen or olive+grass pollen. - positive skin prick test - presence of specific IgE (positive RAST class II and above) 4. Patient informed consent (in local language) 5. Compliant patient being able to complete a diary card for self evaluation of the symptoms score and antisymptomatic medication. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous immunotherapy with mites or grass pollen or olive+grass pollen extracts within the last year. 2. Further allergies wich may interfere during the study period. 3. Patinets treated with beta-blockers. 4. Pregnant women or women planning pregnancy or lactation. 5. Simultaneous participation in other clinical trials. 6. Other reasons contra-indicating an inclusion into the trial according to the investigator's stimation (poor compliance). 7. Chronic drug abuse or alcohol abuse 8. Active tuberculosis 9. Immune disorders 10. Severe chronic-inflammatory diseases 11. Malignancy 12. Irreversible secondary disorders at the target organ (emphysema, bronchoectasis) 13. Period of maxim pollinisation for the considered allergens
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the safety of cluster regimen for a subcutaneos therapy in patients allergic to grass pollen, tree pollen or mites;Secondary Objective: ;Primary end point(s): Evaluation of safety of cluster regimens in subcutaneous immunotherapy in patients with allergic rhinitis/ rhinoconjunctivitis and/or allergic asthma to grass pollen, olive+grass pollen or mites. | — |
Countries
Spain
Outcome results
None listed