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

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

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

Study Overview

• Status: Completed
• Conditions: Allergic Rhinitis
• Intervention / Treatment: Biological: DEPIGOID phleum; Biological: DEPIGOID Placebo

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Phase 2

Contacts and Locations

Study Locations

• Spain
  • Madrid, Spain
    • Hospital Infanta Leonor
  • Malaga, Spain
    • Hospital Regional Universitario Carlos Haya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Biological: DEPIGOID phleum; Subcutaneous Immunotherapy with modified extract of Phleum pollen.
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.	Biological: DEPIGOID phleum; Subcutaneous Immunotherapy with modified extract of Phleum pollen.; Biological: DEPIGOID Placebo; Placebo for subcutaneous administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptoms and medication scores comparison between active and placebo group	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).	two years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Plaza del Hospital Civil
• Collaborators: Laboratorios Leti, S.L.
• Investigators: Principal Investigator: Miguel Blanca, MD, PhD, Hospital Regional Universitario, Málaga, Spain

Publications and helpful links

General Publications

• Rondon C, Blanca-Lopez N, Campo P, Mayorga C, Jurado-Escobar R, Torres MJ, Canto G, Blanca M. Specific immunotherapy in local allergic rhinitis: A randomized, double-blind placebo-controlled trial with Phleum pratense subcutaneous allergen immunotherapy. Allergy. 2018 Apr;73(4):905-915. doi: 10.1111/all.13350. Epub 2017 Nov 28.

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: February 12, 2014
• First Submitted That Met QC Criteria: April 27, 2014
• First Posted (Estimate): April 29, 2014

Study Record Updates

• Last Update Posted (Estimate): November 8, 2016
• Last Update Submitted That Met QC Criteria: November 5, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic
• Other Study ID Numbers: MBG6043179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No