Subcutaneous Immunotherapy With Dermatophagoides Pteronyssinus in Local Allergic Rhinitis

NCT02123316 | Completed Phase 2 DMC

• 2 other identifiers: ECRL12008-003680-392008-003680-39
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Local Allergic Rhinitis

Keywords

local allergic rhinitis; subcutaneous immunotherapy; house dust mite allergy; Dermatophagoides pteronyssinus allergy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• 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

Study Arms (2)

Pangramin Plus D. pteronyssinus

ACTIVE COMPARATOR

Pangramin Plus D. pteronyssinus 100% for subcutaneous injection

Biological: Pangramin Plus D. pteronyssinus

Placebo

PLACEBO COMPARATOR

Placebo for subcutaneous injection

Biological: Placebo

Interventions

Pangramin Plus D. pteronyssinus BIOLOGICAL

Subcutaneous immunotherapy with Dermatophagoides pteronyssinus

Pangramin Plus D. pteronyssinus

Placebo BIOLOGICAL

Placebo for subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Miguel Blanca Gomez: lead

Study Sites (1)

Hospital Carlos Haya

Málaga, Malaga, 29009, Spain

Location

Related Publications (1)

• 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.

  PMID: 27008542 DERIVED

MeSH Terms

Conditions

Dust Mite Allergy

Interventions

Antigens, Dermatophagoides

Condition Hierarchy (Ancestors)

Rhinitis, Allergic, Perennial; Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antigens; Biological Factors

Study Officials

• Miguel Blanca, MD, PhD

  Allergy Unit, Regional University Hospital of Malaga, Spain

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: April 19, 2014
• First Posted: April 25, 2014
• Study Start: January 1, 2010
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: March 31, 2016

Record last verified: 2014-04

Locations

ES (1)