Clinical trial NCT02123316: Subcutaneous Immunotherapy With Dermatophagoides Pteronyssinus in Local Allergic Rhinitis
Official title: Assessment of the Effectiveness of a Dermatophagoides Pteronyssinus Extract, Rated in Units of Mass and Administered Subcutaneously for the Treatment of Local Allergic Rhinitis. Randomized, Double-blind, Placebo-controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Local Allergic Rhinitis
Keywords: local allergic rhinitis
subcutaneous immunotherapy
house dust mite allergy
Dermatophagoides pteronyssinus allergy
Lead sponsor: Plaza del Hospital Civil
Sponsor class: OTHER
First posted: 2014-04-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the efficacy of an extract of Dermatophagoides pteronyssinus versus placebo in the treatment of local allergic rhinitis. The primary efficacy endpoint is the reduction in symptom scores and medication use in the active group compared to placebo.

The influence of treatment in "in vitro" and "in vivo" objective parameters was also assessed.


Eligibility criteria: Inclusion Criteria:

* Prior to study specific examinations the patient has to give his/her written informed consent.
* Local allergic rhinitis induced by Dermatophagoides pteronyssinus (DP).
* Age: 18-55.
* Negative skin prick-test to DP
* Positive nasal allergen provocation test to DP (NAPT-DP) and/or nasal specific IgE (sIgE) to DP\>0.35 kU/L
* If applicable negative urine pregnancy test and willingness to use effective form of contraception for the duration of involvement in the study.

Exclusion Criteria:

* Severe immunopathological or immunodeficiencies diseases.
* Treatment with beta-blockers, even when administered topically
* Severe psychological disorders
* Severe Atopic Dermatitis
* FEV1 \<70% predicted after appropriate pharmacological treatment
* History of hypersensitivity or intolerance to excipients and / or trial medication or other medication to be used for protocol
* Inability to adequately perform diagnostic tests or treatment
* Awareness of other inhaled allergens (perennial or seasonal) clinically relevant to the subject and that may interfere with the response evaluation
* Treatment with immunotherapy in the 5 years prior to his inclusion in the study

Primary outcomes:
measure: Change from Baseline Symptoms-Medication score at 1,3,6,12,18, and 24 months
timeFrame: Baseline, month 1,3,6,12,18, and 24
Secondary outcomes:
measure: Change from Baseline response skin prick-test at 1,3,6,12,18, and 24 months
timeFrame: Baseline, month 1,3,6,12,18, and 24
measure: Change from Baseline response to intradermal test at 1,3,6,12 and 24 months
timeFrame: Baseline, month 1,3,6,12,18, and 24
measure: Change from Baseline flow cytometry study at 1,3,6,12,18, and 24 months
timeFrame: Baseline, month 1,3,6,12,18, and 24
measure: Change from Baseline determination of tryptase, eosinophilic cationic protein, IgG, IgG4 and specific D. pteronyssinus-IgE by Immunoassay at 1,3,6,12,18, and 24 months
timeFrame: Baseline, month 1,3,6,12,18 and 24
measure: Change from Baseline response to nasal allergen provocation test with Dermatophagoides pteronyssinus at 1,3,6,12,18 and 24 months
timeFrame: Baseline, month 1,3,6,12,18 and 24
measure: Adverse event
timeFrame: 2 years
Other outcomes:
Locations:
city: Malaga
country: Spain
facility: Hospital Carlos Haya
Study officials:
affiliation: Allergy Unit, Regional University Hospital of Malaga, Spain
name: Miguel Blanca, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rondon C, Campo P, Salas M, Aranda A, Molina A, Gonzalez M, Galindo L, Mayorga C, Torres MJ, Blanca M. Efficacy and safety of D. pteronyssinus immunotherapy in local allergic rhinitis: a double-blind placebo-controlled clinical trial. Allergy. 2016 Jul;71(7):1057-61. doi: 10.1111/all.12889. Epub 2016 Apr 13.