Efficacy of a Depigmented Extract of Phleum in Local Allergic Rhinitis

Allergic Rhinitis Clinical Trial

— GRAMAL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02126111
• Other study ID #: MBG6043179
• Status: Completed
• Phase: Phase 2
• First received: February 12, 2014
• Last updated: November 5, 2016
• Start date: October 2010
• Est. completion date: April 2016

Study information

• Verified date: November 2016
• Source: Plaza del Hospital Civil
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Biological:
• DEPIGOID phleum
Subcutaneous Immunotherapy with modified extract of Phleum pollen.
• DEPIGOID Placebo
Placebo for subcutaneous administration

Locations

Country	Name	City	State
Spain	Hospital Infanta Leonor	Madrid
Spain	Hospital Regional Universitario Carlos Haya	Malaga

Sponsors (2)

Lead Sponsor	Collaborator
Plaza del Hospital Civil	Laboratorios Leti, S.L.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Skin prick-test (SPT) with phleum.	Evaluation of SPT wheal size.	2 years	No
Secondary	Intradermal test (IDT) with phleum	IDT wheal and erythema size.	2 years	No
Secondary	FEV1		2 years	No
Secondary	Quality of life questionnaire RQLQ		2 years	No
Secondary	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	No
Secondary	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	No
Secondary	Heart rate		2 years	No
Secondary	Blood pressure		2 years	No
Secondary	Adverse events		2 years	Yes