Ignite Creation Date:
2024-05-06 @ 1:23 AM
Last Modification Date:
2024-10-26 @ 11:03 AM
Study NCT ID:
NCT01795846
Status:
UNKNOWN
Last Update Posted:
2013-03-01
First Post:
2013-02-20
Brief Title:
Evaluation of Immunological Changes and Clinical Efficacy of Specific Immunotherapy With Der p House Dust Mite Allergen in Polysensitized and Monosensitized Patients With Allergic Rhinitis andor Asthma
Sponsor:
Ankara University
Organization:
Ankara University
Study Overview
Official Title:
None
Status:
UNKNOWN
Status Verified Date:
2013-02
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The incidence of allergic rhinitis and asthma is increasing in throughout the world as well as our country Allergen-specific immunotherapy has been in use for almost 100 years Since then it is recommended for the management of Immunoglobulin E IgE-mediated allergic diseases as the only immune modulator therapeutic tool It is well documented that allergen immunotherapy performed using single allergen is efficacious in monosensitized patients Hence polysensitization is much more prevalent than monosensitization in patients with respiratory allergy On the other hand polysensitization may have a paramount relevance in clinical practice for example many allergists have doubts in choosing the allergen extract for allergen specific immunotherapy In this regard the evaluation of immunotherapy efficacy in polysensitized patients still represents an unanswered question and there are very few studies on this issue However most clinical trials of allergen immunotherapy have been performed with multiple different allergen extracts using sublingual route To the best of our knowledge no common single-allergen house dust mite Dermatophagoides pteronyssinus Der p subcutaneous immunotherapy trials have been specifically designed to compare efficacy in monosensitized and polysensitized patients Furthermore few studies have demonstrated that monosensitized and polysensitized patients appear to differ in terms of their immune reactivity But it is unknown whether single-allergen immunotherapy protocol elicit distinct immune responses in monosensitized and polysensitized patients
The aim of this study was to investigate the immunological changes and clinical effectiveness of most relevant single-allergen immunotherapy in patients with allergic rhinitis andor asthma The study population will included 40 adult patients with moderatesevere perennial allergic rhinitis and mildmoderate asthma who were monosensitized to house dust mites or sensitized to at least 2 different allergens including house dust mites No patient will previously had been performed allergen immunotherapy The study plan is prospective randomized double-blind placebo-controlled Both groups will first received placebo injections for 3 months and followed by a cluster immunotherapy schedule After the maintenance dose will be reached within 6 weeks injections will be received at monthly intervals Standardized depot preparations of Der p extract Alutard Standard Quality SQ ALK-Abello Company Name Madrid Spain were administered by means of subcutaneous injection All eligible patients will underwent 8 weeks run-in period to evaluate their baseline clinical status based on history of allergy symptom and medication usage for rhinitis and asthma skin prick testing pulmonary function tests and methacholine bronchoprovocation tests According to the sensitizations patients will be divided to 2 parallel groups either as polysensitized or monosensitized Afterwards both patient groups will be followed by symptom and medication scales visual analog scores quality-of-life scores for 1 month before placebo and immunotherapy During this period total serum IgE specific IgE levels will be measured using the method of UNI-CAP 100 Phadia Uppsala Sweden and repeated after placebo and immunotherapy injections At baseline after placebo 3 months and immunotherapy injections at third months of maintenance period nasal allergen provocation test with Der p extract will applied to the study groups Peripheral whole blood will drawn for the analysis of basophil activation marker CD203c CD cell differentiation expression at this three time points For the clinical assessment all patients will record on diary cards their symptom scores visual analog scale scores medication usage quality-of-life measures for rhinitis and asthma On each clinical visit physical examination and side effects will be collected from diary card data In conclusion we believe that this study may be help for more understanding of the immune response to allergen specific immunotherapy at early stage On the other hand if the similar clinical improvement is demonstrated between the two groups with common single-allergen Der p immunotherapy unnecessary usage of multiple allergens may be prevented as well as therapeutic side affects and cost
The aim of this study was to investigate the immunological changes and clinical effectiveness of most relevant single-allergen immunotherapy in patients with allergic rhinitis andor asthma The study population will included 40 adult patients with moderatesevere perennial allergic rhinitis and mildmoderate asthma who were monosensitized to house dust mites or sensitized to at least 2 different allergens including house dust mites No patient will previously had been performed allergen immunotherapy The study plan is prospective randomized double-blind placebo-controlled Both groups will first received placebo injections for 3 months and followed by a cluster immunotherapy schedule After the maintenance dose will be reached within 6 weeks injections will be received at monthly intervals Standardized depot preparations of Der p extract Alutard Standard Quality SQ ALK-Abello Company Name Madrid Spain were administered by means of subcutaneous injection All eligible patients will underwent 8 weeks run-in period to evaluate their baseline clinical status based on history of allergy symptom and medication usage for rhinitis and asthma skin prick testing pulmonary function tests and methacholine bronchoprovocation tests According to the sensitizations patients will be divided to 2 parallel groups either as polysensitized or monosensitized Afterwards both patient groups will be followed by symptom and medication scales visual analog scores quality-of-life scores for 1 month before placebo and immunotherapy During this period total serum IgE specific IgE levels will be measured using the method of UNI-CAP 100 Phadia Uppsala Sweden and repeated after placebo and immunotherapy injections At baseline after placebo 3 months and immunotherapy injections at third months of maintenance period nasal allergen provocation test with Der p extract will applied to the study groups Peripheral whole blood will drawn for the analysis of basophil activation marker CD203c CD cell differentiation expression at this three time points For the clinical assessment all patients will record on diary cards their symptom scores visual analog scale scores medication usage quality-of-life measures for rhinitis and asthma On each clinical visit physical examination and side effects will be collected from diary card data In conclusion we believe that this study may be help for more understanding of the immune response to allergen specific immunotherapy at early stage On the other hand if the similar clinical improvement is demonstrated between the two groups with common single-allergen Der p immunotherapy unnecessary usage of multiple allergens may be prevented as well as therapeutic side affects and cost
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None