Efficacy of a Depigmented Extract of Phleum in Local Allergic Rhinitis

Overview

The purpose of this study is evaluate the efficacy of a depigmented grass extract in the treatment of local allergic rhinitis.

Full Title of Study: “Efficacy of a Depigmented Extract of Phleum in the Treatment of Local Allergic Rhinitis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: April 2016

Interventions

  • Biological: DEPIGOID phleum
    • Subcutaneous Immunotherapy with modified extract of Phleum pollen.
  • Biological: DEPIGOID Placebo
    • Placebo for subcutaneous administration

Arms, Groups and Cohorts

  • Active Comparator: DEPIGOID phleum
    • The active treatment arm receive active phleum pollen immunotherapy (Depigoid 100% phleum). Depigmented and polymerized allergen extract of Phleum pollen for subcutaneous injection.
  • Placebo Comparator: DEPIGOID Placebo & DEPIGOID Phleum
    • This arm receive DEPIGOID Placebo during the first year, and DEPIGOID Phleum during the second year of study. DEPIGOID Placebo contains the same composition as in the active DEPIGOID Phleum with the only difference being the exclusion of the phleum pollen allergen extract.

Clinical Trial Outcome Measures

Primary Measures

  • Symptoms and medication scores comparison between active and placebo group
    • Time Frame: two years
    • Patients were provided a diary to score the severity of their symptoms and the use of rescue medication during 4 weeks in two consecutive springs. 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 Measures

  • Response to nasal allergen provocation test with phleum (NAPT-Phl)
    • Time Frame: two years
    • The response to NAPT-Phl with increasing concentrations of phleum pratense (0.001-0.01-0.05-0.1 mcg/ml) will be evaluated by nasal symptoms and acoustic rhinometry.
  • Skin prick-test (SPT) with phleum.
    • Time Frame: 2 years
    • Evaluation of SPT wheal size.
  • Intradermal test (IDT) with phleum
    • Time Frame: 2 years
    • IDT wheal and erythema size.
  • FEV1
    • Time Frame: 2 years
  • Quality of life questionnaire RQLQ
    • Time Frame: 2 years
  • Flow cytometry study for determination of IFN-gamma, IL-13, IL-5, IL-8, IL-10, IL-12, IL-2 in peripheral blood and nasal lavage
    • Time Frame: 2 years
  • Determination of tryptase, eosinophil cationic protein, IgG, IgG4, specific IgE to grass (Phl p1, Phl p5, Phl p7, Phl p12) in peripheral blood and nasal lavage.
    • Time Frame: 2 years
  • Heart rate
    • Time Frame: 2 years
  • Blood pressure
    • Time Frame: 2 years
  • Adverse events
    • Time Frame: 2 years

Participating in This Clinical Trial

Inclusion Criteria

  • Local allergic rhinitis with sensitization to grass pollen – Skin prick test and serum specific IgE negative to grass pollen. – Positive Nasal allergen provocation test (NAPT) to grass pollen and/or positive nasal specific IgE to grass pollen. – Written informed consent Exclusion Criteria:

  • Immunological diseases – Heart diseases that limit the use of adrenaline. For example, severe hypertension or treatment with beta-blockers. – Treatment with beta-blockers – Severe psychological disorders – Severe atopic dermatitis – FEV1 < 70% of reference value after treatment – Hypersensitivity or intolerance to excipients and / or medication trial. – Failure to adequately perform diagnostic tests or treatment. – Sensitization to other allergens (perennial or seasonal) with clinical relevance for the subject and that may interfere in the evaluation of the response. – Immunotherapy in the 5 years prior to their inclusion in the study. – Pregnant women or at risk of pregnancy and lactating women.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 55 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Plaza del Hospital Civil
  • Collaborator
    • Laboratorios Leti, S.L.
  • Provider of Information About this Clinical Study
    • Principal Investigator: Miguel Blanca Gomez, Director Allergy Unit – Plaza del Hospital Civil
  • Overall Official(s)
    • Miguel Blanca, MD, PhD, Principal Investigator, Hospital Regional Universitario, Málaga, Spain

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