Evaluación de los cambios inmunológicos tras la inmunoterapia subcutánea con un extracto de Phleum pratense
- Conditions
- RhinoconjunctivitisMedDRA version: 7.1Level: PTClassification code 10010744
- Registration Number
- EUCTR2005-003460-35-ES
- Lead Sponsor
- ALK-Abelló, S.A.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 0
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
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.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>Tolerability<br>;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
- Secondary Outcome Measures
Name Time Method