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

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
DEPIGOID phleum
DEPIGOID Placebo
Sponsored by
Plaza del Hospital Civil
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

  • Hospital Infanta Leonor
  • Hospital Regional Universitario Carlos Haya

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

DEPIGOID phleum

DEPIGOID Placebo & DEPIGOID Phleum

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.
Skin prick-test (SPT) with phleum.
Evaluation of SPT wheal size.
Intradermal test (IDT) with phleum
IDT wheal and erythema size.
FEV1
Quality of life questionnaire RQLQ
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
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.
Heart rate
Blood pressure
Adverse events

Full Information

First Posted
February 12, 2014
Last Updated
November 5, 2016
Sponsor
Plaza del Hospital Civil
Collaborators
Laboratorios Leti, S.L.
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1. Study Identification

Unique Protocol Identification Number
NCT02126111
Brief Title
Efficacy of a Depigmented Extract of Phleum in Local Allergic Rhinitis
Acronym
GRAMAL
Official Title
Efficacy of a Depigmented Extract of Phleum in the Treatment of Local Allergic Rhinitis
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Plaza del Hospital Civil
Collaborators
Laboratorios Leti, S.L.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DEPIGOID phleum
Arm Type
Active Comparator
Arm Description
The active treatment arm receive active phleum pollen immunotherapy (Depigoid 100% phleum). Depigmented and polymerized allergen extract of Phleum pollen for subcutaneous injection.
Arm Title
DEPIGOID Placebo & DEPIGOID Phleum
Arm Type
Placebo Comparator
Arm 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.
Intervention Type
Biological
Intervention Name(s)
DEPIGOID phleum
Intervention Description
Subcutaneous Immunotherapy with modified extract of Phleum pollen.
Intervention Type
Biological
Intervention Name(s)
DEPIGOID Placebo
Intervention Description
Placebo for subcutaneous administration
Primary Outcome Measure Information:
Title
Symptoms and medication scores comparison between active and placebo group
Description
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).
Time Frame
two years
Secondary Outcome Measure Information:
Title
Response to nasal allergen provocation test with phleum (NAPT-Phl)
Description
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.
Time Frame
two years
Title
Skin prick-test (SPT) with phleum.
Description
Evaluation of SPT wheal size.
Time Frame
2 years
Title
Intradermal test (IDT) with phleum
Description
IDT wheal and erythema size.
Time Frame
2 years
Title
FEV1
Time Frame
2 years
Title
Quality of life questionnaire RQLQ
Time Frame
2 years
Title
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
Title
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
Title
Heart rate
Time Frame
2 years
Title
Blood pressure
Time Frame
2 years
Title
Adverse events
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miguel Blanca, MD, PhD
Organizational Affiliation
Hospital Regional Universitario, Málaga, Spain
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Infanta Leonor
City
Madrid
Country
Spain
Facility Name
Hospital Regional Universitario Carlos Haya
City
Malaga
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29168570
Citation
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.
Results Reference
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Efficacy of a Depigmented Extract of Phleum in Local Allergic Rhinitis

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