Efficacy of a Depigmented Extract of Phleum in Local Allergic Rhinitis

Phase 2

Completed

• Conditions: Allergic Rhinitis

• 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

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