Rhinoconjunctivitis MedDRA version: 7.1 Level: PT Classification code 10010744
Conditions
Interventions
Trade Name: Pangramín Depot Phleum pratense
Product Name: Pangramín Depot Phleum pratense
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Phleum pratense
Concentration unit: µg/ml mic
Sponsors
ALK-Abelló, S.A.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age between 18 and 55 years old. Clinical history of rhinoconjunctivitis for sensitisation to grass pollen with or without asthma. Positive skin prick tests to grass pollen mix extract. Negative pregnancy test in potentially fertile women. 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) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: FEV1 < 80% of predicted value Asthma and /or severe atopic dermatitis. Previous immunotherapy with grass pollen in the last 5 years. Contraindications of immunotherapy and/or any clinical disease which may affect the results of the study or compromise patient’s safety.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the immunological changes to a grass pollen mix extract after subcutaneous immunotherapy with Phleum pratense. ;Secondary Objective: To evaluate the immunological response to Phleum pratense. Tolerability ;Primary end point(s): The evaluation of changes in immediate skin reactivity (wheal area), analyzed by Parallel Lines Assay (PLA) in patients treated with Phleum pratense | — |
Countries
Spain
Outcome results
None listed