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Completed

NCT Number: NCT02126111

Efficacy of a Depigmented Extract of Phleum in Local Allergic Rhinitis

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

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Key information

Conditions

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

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Infanta Leonor, Madrid, Spain

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Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Depigoid Phleum

Biological

Subcutaneous Immunotherapy with modified extract of Phleum pollen.

DEPIGOID Placebo

Biological

Placebo for subcutaneous administration

Primary outcomes

  1. 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 outcomes

  1. 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.

  2. Skin prick-test (SPT) with phleum.

    Time frame: 2 years

    Evaluation of SPT wheal size.

  3. Intradermal test (IDT) with phleum

    Time frame: 2 years

    IDT wheal and erythema size.

  4. FEV1

    Time frame: 2 years

  5. Quality of life questionnaire RQLQ

    Time frame: 2 years

  6. 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

  7. 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

  8. Heart rate

    Time frame: 2 years

  9. Blood pressure

    Time frame: 2 years

  10. Adverse events

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

Plaza del Hospital Civil

Other

Collaborators

  • Laboratorios Leti, S.L.

Registry information

Official study title

Efficacy of a Depigmented Extract of Phleum in the Treatment of Local Allergic Rhinitis

Acronym: GRAMAL

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
Apr 29, 2014
Registry last updated
Nov 8, 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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