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Completed

NCT Number: NCT02123316

Subcutaneous Immunotherapy With Dermatophagoides Pteronyssinus in Local Allergic Rhinitis

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.

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Key information

Conditions

Local Allergic Rhinitis Dust Mite Allergy Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Perennial

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Carlos Haya

Málaga, Malaga, 29009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pangramin Plus D. pteronyssinus

Biological

Subcutaneous immunotherapy with Dermatophagoides pteronyssinus

Placebo

Biological

Placebo for subcutaneous injection

Primary outcomes

  1. Change from Baseline Symptoms-Medication score at 1,3,6,12,18, and 24 months

    Time frame: Baseline, month 1,3,6,12,18, and 24

    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 outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. Adverse event

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Miguel Blanca Gomez

Other

Registry information

Official study 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.

Acronym: ECRL1

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Apr 25, 2014
Registry last updated
Mar 31, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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