Subcutaneous Immunotherapy With Dermatophagoides Pteronyssinus in Local Allergic Rhinitis

Local Allergic Rhinitis Clinical Trial

— ECRL1  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02123316
• Other study ID #: ECRL12008-003680-39
• Secondary ID: 2008-003680-39
• Status: Completed
• Phase: Phase 2
• First received: April 19, 2014
• Last updated: March 30, 2016
• Start date: January 2010
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Plaza del Hospital Civil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Local Allergic Rhinitis
• Rhinitis

Intervention

Biological:
• Pangramin Plus D. pteronyssinus
Subcutaneous immunotherapy with Dermatophagoides pteronyssinus
• Placebo
Placebo for subcutaneous injection

Locations

Country	Name	City	State
Spain	Hospital Carlos Haya	Malaga

Sponsors (1)

Lead Sponsor	Collaborator
Miguel Blanca Gomez

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Symptoms-Medication score at 1,3,6,12,18, and 24 months	Patients were provided a diary to score the severity of their symptoms and the use of rescue medication during 4 consecutive weeks.; Nasal symptoms of rhinorrhea, nasal congestion, sneezing, nasal itching, and ocular symptoms were recorded using a 4-point categorical scale from 0 to 3 (0: no symptoms, 1:mild, 2:moderate; 3:severe).; The use of rescue medication was recorded in the patient diary according to the following score: Oral antihistamines (1 tablet = 1 point); intranasal corticosteroids (400mcg/day of beclometasone or equivalent = 1.4 points); and ocular antihistamines (1 dose = 1 point).	Baseline, month 1,3,6,12,18, and 24	No
Secondary	Change from Baseline response skin prick-test at 1,3,6,12,18, and 24 months		Baseline, month 1,3,6,12,18, and 24	No
Secondary	Change from Baseline response to intradermal test at 1,3,6,12 and 24 months		Baseline, month 1,3,6,12,18, and 24	No
Secondary	Change from Baseline flow cytometry study at 1,3,6,12,18, and 24 months		Baseline, month 1,3,6,12,18, and 24	No
Secondary	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		Baseline, month 1,3,6,12,18 and 24	No
Secondary	Change from Baseline response to nasal allergen provocation test with Dermatophagoides pteronyssinus at 1,3,6,12,18 and 24 months		Baseline, month 1,3,6,12,18 and 24	No
Secondary	Adverse event		2 years	Yes