Anti-inflammatory H1 Antihistamines Allergic Rhinitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

115 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2013-05-31

Brief Summary

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The main purpose of the treatment of persistent allergic rhinitis is to improve symptoms and patients' quality of life and prevent the development of asthma. Therapeutic strategies also target a reduction of pro-inflammatory mediators released from activated cells, including mast cells and epithelial cells. The presence of allergic inflammation in nasal mucosa may increase the risk of asthma occurrence, especially in patients with persistent allergic rhinitis. H1 antihistamines are widely recommended in all types of allergic rhinitis, regardless of symptom severity or persistence. They control all of the symptoms, but to a lesser extent nasal congestion. New generation agents, such as levocetirizine and desloratadine, possess anti-inflammatory properties, reducing allergic inflammation.

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Detailed Description

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Allergic rhinitis is characterized by a chronic inflammation of nasal mucosa and represents a risk factor for asthma occurrence. H1 antihistamines reduce the rhinitis' symptoms, but some compounds may have anti-inflammatory properties.

We evaluated the plasmatic level of some cytokines in patients with persistent allergic rhinitis (PAR) and their evolution after 4-week treatment with H1 antihistamines and the risk of asthma after 1.5 year.

Eighty-five patients with PAR and 30 healthy volunteers were included in the study. The patients with PAR were randomly divided into 2 groups: 41 patients treated with desloratadine 5 mg/day and 44 patients under levocetirizine 5 mg/day for 4 weeks.

The clinical evaluation include the presence and severity of allergic rhinitis' symptoms: rhinorrhea, nasal congestion, sneezing, nasal and ocular itching and duration of the disease.

Each symptom was evaluated on scale from 0 to 3 (0=absent, 1=mild, 2=moderate, 3=severe) and after that we calculated the total symptoms score (TSS).

A TSS\<6 means a mild rhinitis, while a TSS\> 6 represented a moderate severe one.

The patients were clinically evaluated after 1.5 year to determine the possible onset of bronchial asthma.

The biological evaluation means determination of total IgE and plasmatic level of IL-1 beta, IL-6, IL-8 and TNF alpha.

Clinical and biological evaluation were performed before and after treatment

Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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healthy volunteers

Group Type NO_INTERVENTION

No interventions assigned to this group

Desloratadine

patients with allergic rhinitis under treatment with Desloratadine 5 mg/day, 4 weeks

Group Type ACTIVE_COMPARATOR

Desloratadine

Intervention Type DRUG

administration of Desloratadine 5 mg/day for 4 weeks

Levocetirizine

patients with allergic rhinitis under treatment with Levocetirizine 5 mg/day, 4 weeks

Group Type ACTIVE_COMPARATOR

Levocetirizine

Intervention Type DRUG

administration of Levocetirizine 5 mg/day for 4 weeks

Interventions

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Levocetirizine

administration of Levocetirizine 5 mg/day for 4 weeks

Intervention Type DRUG

Desloratadine

administration of Desloratadine 5 mg/day for 4 weeks

Intervention Type DRUG

Other Intervention Names

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Xyzal Aerius

Eligibility Criteria

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Inclusion Criteria

* persistent allergic rhinitis

Exclusion Criteria

* the presence of asthma or nasal polyps,
* acute and chronic upper respiratory infections,
* administration of intranasal or systemic corticosteroids or H1 antihistamines in the past 30 days.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes