Immunotherapy With Depigmented and Polymerized Allergen Extract of Phleum Pratense
Maneno muhimu
Kikemikali
Maelezo
Immunotherapy is a specific treatment for allergic diseases. Unlike conventional pharmacological treatment, immunotherapy is the only treatment that could modify the natural course of allergic disease. This is a prospective double-blind placebo controlled study with three arms of treatment: placebo and two active (one of the active arms will receive a dose that is 10x the dose of the other arm).
Tarehe
| Imethibitishwa Mwisho: | 11/30/2010 |
| Iliyowasilishwa Kwanza: | 07/12/2007 |
| Uandikishaji uliokadiriwa Uliwasilishwa: | 07/12/2007 |
| Iliyotumwa Kwanza: | 07/15/2007 |
| Sasisho la Mwisho Liliwasilishwa: | 12/15/2010 |
| Sasisho la Mwisho Lilichapishwa: | 12/16/2010 |
| Tarehe halisi ya kuanza kwa masomo: | 08/31/2007 |
| Tarehe ya Kukamilisha Msingi iliyokadiriwa: | 09/30/2009 |
| Tarehe ya Kukamilisha Utafiti: | 09/30/2009 |
Hali au ugonjwa
Uingiliaji / matibabu
Biological: Immunotherapy with modified extract of P. pratense pollen
Other: C
Awamu
Vikundi vya Arm
| Mkono | Uingiliaji / matibabu |
|---|---|
| Experimental: A: Biological vaccine The first active arm will receive a dose that is 10x less than the dose of the other arm | |
| Experimental: B: biological vaccine The first active arm will receive a dose that is 10x more than the dose of the other arm | |
| Placebo Comparator: C | Other: C Placebo 2 drops daily |
Vigezo vya Kustahiki
| Zama zinazostahiki Kujifunza | 12 Years Kwa 12 Years |
| Jinsia Inastahiki Kujifunza | All |
| Hupokea Wajitolea wa Afya | Ndio |
| Vigezo | Inclusion Criteria: - Positive clinical history of allergy to Phleum pratense - Patients of both gender aged from 12 up to 50 years. - Positive prick test to Phleum pratense allergen extracts - Specific IgE to Phleum pratense - Positive clinical history of allergic rhinoconjunctivitis and/or asthma - Written informed consent. Exclusion Criteria: - Use of immunotherapy during the last four years. - Any contraindication for the use of immunotherapy in accordance with European Allergy and Clinical Immunology Immunotherapy Subcommittee criteria: - Treatment with ß-blockers - Coexistence of immunopathological diseases (e.g. of the liver, kidney, the nervous system, thyroid gland, rheumatic diseases) in which autoimmune mechanisms play a role - Patients suffering from immune deficiencies - Patients with serious psychiatric / psychological disturbances - In addition, the following was considered as exclusion criteria: - Pregnant or/ in lactation patients - Patients aspirin intolerance |
Matokeo
Hatua za Matokeo ya Msingi
1. Symptom scores [1 year]
Hatua za Matokeo ya Sekondari
1. Nasal provocation test [1 year]
2. Dose-response skin prick-test [1 year]
3. Asthma quality of life questionnaire (AQLQ)/Rhinoconjunctivitis quality of life questionnaire (RQLQ) [1 year]
4. Medication scores [1 year]
5. Visual scales [1 year]
6. "In vitro" immunological tests [1 year]
7. Record of adverse events [1 year]
