Subcutaneous Immunotherapy With Dermatophagoides Pteronyssinus in Local Allergic Rhinitis (ECRL1)

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.

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.

Study Overview

• Status: Completed
• Conditions: Local Allergic Rhinitis
• Intervention / Treatment: Biological: Pangramin Plus D. pteronyssinus; Biological: Placebo

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Malaga, Spain, 29009
    • Hospital Carlos Haya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 51 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pangramin Plus D. pteronyssinus; Pangramin Plus D. pteronyssinus 100% for subcutaneous injection	Biological: Pangramin Plus D. pteronyssinus; Subcutaneous immunotherapy with Dermatophagoides pteronyssinus
Placebo Comparator: Placebo; Placebo for subcutaneous injection	Biological: Placebo; Placebo for subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Time Frame
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
Change from Baseline response to intradermal test at 1,3,6,12 and 24 months	Baseline, month 1,3,6,12,18, and 24
Change from Baseline flow cytometry study at 1,3,6,12,18, and 24 months	Baseline, month 1,3,6,12,18, and 24
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
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
Adverse event	2 years

Collaborators and Investigators

• Sponsor: Miguel Blanca Gomez
• Investigators: Principal Investigator: Miguel Blanca, MD, PhD, Allergy Unit, Regional University Hospital of Malaga, Spain

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): April 1, 2014

Study Registration Dates

• First Submitted: April 19, 2014
• First Submitted That Met QC Criteria: April 23, 2014
• First Posted (Estimate): April 25, 2014

Study Record Updates

• Last Update Posted (Estimate): March 31, 2016
• Last Update Submitted That Met QC Criteria: March 30, 2016
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: subcutaneous immunotherapy; house dust mite allergy; local allergic rhinitis; Dermatophagoides pteronyssinus allergy
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: ECRL12008-003680-39; 2008-003680-39 (EudraCT Number)