Efficacy of a Depigmented Extract of Phleum in Local Allergic Rhinitis (GRAMAL)

Plaza del Hospital Civil

Status and phase: Completed; Phase 2

Conditions: Allergic Rhinitis

Treatments: Biological: DEPIGOID Placebo; Biological: DEPIGOID phleum

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02126111

MBG6043179

Details and patient eligibility

About

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

Enrollment: 56 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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56 participants in 2 patient groups, including a placebo group

DEPIGOID phleum

Active Comparator group

Description:

The active treatment arm receive active phleum pollen immunotherapy (Depigoid 100% phleum). Depigmented and polymerized allergen extract of Phleum pollen for subcutaneous injection.

Treatment:

Biological: DEPIGOID phleum

DEPIGOID Placebo & DEPIGOID Phleum

Placebo Comparator group

Description:

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.

Treatment:

Biological: DEPIGOID Placebo

Biological: DEPIGOID phleum