Efficacy of a Depigmented Extract of Phleum in Local Allergic Rhinitis

Phase 2

Completed

• Conditions: Allergic Rhinitis
• Interventions: Biological: DEPIGOID phleum; Biological: DEPIGOID Placebo

• Registration Number: NCT02126111
• Lead Sponsor: Plaza del Hospital Civil

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2014-02-12
• Study First Submitted QC: 2014-04-27
• Study First Posted: 2014-04-29
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-05
• Last Update Posted: 2016-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DEPIGOID phleum	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.
DEPIGOID Placebo & DEPIGOID Phleum	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.
DEPIGOID Placebo & DEPIGOID Phleum	DEPIGOID Placebo	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.

Primary Outcome Measures

Name	Time	Method
Symptoms and medication scores comparison between active and placebo group	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 Outcome Measures

Name	Time	Method
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	2 years
Heart rate	2 years
Blood pressure	2 years
Intradermal test (IDT) with phleum	2 years	IDT wheal and erythema size.
FEV1	2 years
Adverse events	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.	2 years
Quality of life questionnaire RQLQ	2 years
Response to nasal allergen provocation test with phleum (NAPT-Phl)	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.	2 years	Evaluation of SPT wheal size.

Trial Locations

Locations (2)

Hospital Infanta Leonor; 🇪🇸 Madrid, Spain

Hospital Regional Universitario Carlos Haya; 🇪🇸 Malaga, Spain