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

Primary Purpose

Local Allergic Rhinitis

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Pangramin Plus D. pteronyssinus
Placebo
Sponsored by
Miguel Blanca Gomez
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Local Allergic Rhinitis focused on measuring local allergic rhinitis, subcutaneous immunotherapy, house dust mite allergy, Dermatophagoides pteronyssinus allergy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Carlos Haya

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Pangramin Plus D. pteronyssinus

Placebo

Arm Description

Pangramin Plus D. pteronyssinus 100% for subcutaneous injection

Placebo for subcutaneous injection

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Change from Baseline response skin prick-test at 1,3,6,12,18, and 24 months
Change from Baseline response to intradermal test at 1,3,6,12 and 24 months
Change from Baseline flow cytometry study at 1,3,6,12,18, and 24 months
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
Change from Baseline response to nasal allergen provocation test with Dermatophagoides pteronyssinus at 1,3,6,12,18 and 24 months
Adverse event

Full Information

First Posted
April 19, 2014
Last Updated
March 30, 2016
Sponsor
Miguel Blanca Gomez
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1. Study Identification

Unique Protocol Identification Number
NCT02123316
Brief Title
Subcutaneous Immunotherapy With Dermatophagoides Pteronyssinus in Local Allergic Rhinitis
Acronym
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.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Miguel Blanca Gomez

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Local Allergic Rhinitis
Keywords
local allergic rhinitis, subcutaneous immunotherapy, house dust mite allergy, Dermatophagoides pteronyssinus allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pangramin Plus D. pteronyssinus
Arm Type
Active Comparator
Arm Description
Pangramin Plus D. pteronyssinus 100% for subcutaneous injection
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo for subcutaneous injection
Intervention Type
Biological
Intervention Name(s)
Pangramin Plus D. pteronyssinus
Intervention Description
Subcutaneous immunotherapy with Dermatophagoides pteronyssinus
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
Placebo for subcutaneous injection
Primary Outcome Measure Information:
Title
Change from Baseline Symptoms-Medication score at 1,3,6,12,18, and 24 months
Description
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).
Time Frame
Baseline, month 1,3,6,12,18, and 24
Secondary Outcome Measure Information:
Title
Change from Baseline response skin prick-test at 1,3,6,12,18, and 24 months
Time Frame
Baseline, month 1,3,6,12,18, and 24
Title
Change from Baseline response to intradermal test at 1,3,6,12 and 24 months
Time Frame
Baseline, month 1,3,6,12,18, and 24
Title
Change from Baseline flow cytometry study at 1,3,6,12,18, and 24 months
Time Frame
Baseline, month 1,3,6,12,18, and 24
Title
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
Time Frame
Baseline, month 1,3,6,12,18 and 24
Title
Change from Baseline response to nasal allergen provocation test with Dermatophagoides pteronyssinus at 1,3,6,12,18 and 24 months
Time Frame
Baseline, month 1,3,6,12,18 and 24
Title
Adverse event
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel Blanca, MD, PhD
Organizational Affiliation
Allergy Unit, Regional University Hospital of Malaga, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Carlos Haya
City
Malaga
ZIP/Postal Code
29009
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
27008542
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.
Results Reference
derived

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Subcutaneous Immunotherapy With Dermatophagoides Pteronyssinus in Local Allergic Rhinitis

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