Allergen Immunotherapy in Elderly Patients Clinical Trial
— HDMeldOfficial title:
House Dust Mite Injection Immunotherapy: a Double-blind, Placebo Controlled Study in Elderly Patients With Allergic Rhinitis.
| Verified date | July 2017 |
| Source | Medical University of Silesia |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Background. Immunotherapy in elderly patients is controversial, and there is still not much
evidences supporting this treatment's safety and efficacy in this population. This study was
performed to evaluate the safety and efficacy of specific injection immunotherapy for house
dust mite allergens in patients over 65 years of age with allergic rhinitis and a confirmed
allergy to house dust mites. The primary endpoint was the change from baseline in the mean
average adjusted symptom score (AAdSS) and the total combined rhinitis score (TCRS)
difference in the least square means in the label in comparison to placebo.
Materials and methods. The study with double blind, placebo controlled trial was conducted in
one centre. Fifty eight elderly patients with house dust mites allergy and AR were
individually randomized in comparable numbers to one of two parallel groups: two years
perennial AIT with the use Purethal Mites or placebo. Symptoms and medication score were
presented as AAdSS and TCRS. Quality of life based on Rhinoconjunctivitis Quality of Life
Questionnaire (RQLQ), serum allergen specific IgG4 to D.pteronyssinus and D. farinae and Der
p1 and Der p2 were monitoring.
| Status | Completed |
| Enrollment | 58 |
| Est. completion date | April 15, 2017 |
| Est. primary completion date | June 20, 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - The subjects had moderate or severe intermittent allergic rhinitis and fulfilled the Allergic Rhinitis and its Impact on Asthma (ARIA) criterion - the patients included in the study all had a positive skin prick test (SPT), were positive for specific immunoglobulin E (sIgE), and had positive nasal provocation tests (NPTs) with D.pteronyssinus and D. farinae allergens. Exclusion Criteria: - Patients with a clinical allergy and/or a positive skin prick test and specific IgE to other inhalant allergens were excluded from the study. Additionally, patients with any of the following characteristics were also excluded: diagnosis of bronchial asthma, non-allergic rhinitis and severe non-stable diseases. Patients with other nasal problems, such as chronic nasal obstruction, reduced olfaction, bacterial colonization, and chronic sinusitis, were diagnosed based on a CT scan and nasal endoscopy were excluded. Subjects with other chronic or acute clinical disorders or with a history of respiratory tract infections within four weeks of the study initiation were also excluded. |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Medical University of Silesia |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | The serum-speci?c IgE, IgG and IgG4 levels to HDM (D. pteronyssinus, D. farinae) and to Der p1 and Der p2 were determined | ELISA test results in IU/L | baseline and 24 months | |
| Primary | The primary endpoint was the change from baseline in the mean AAdSS score difference in comparison to placebo. | Symptoms and medication score were presented as the average adjusted symptom score (AAdSS): score result with standard deviation | baseline and 24 months | |
| Secondary | Patients' quality of life was evaluated with the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) score | fill the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) - score result | baseline, after 12 months and 24 months of study |