Anti-inflammatory H1 Antihistamines Allergic Rhinitis

Sponsor

Iuliu Hatieganu University of Medicine and Pharmacy (Other)

Overall Status

Completed

CT.gov ID

NCT02507635

Collaborator

(none)

115

Enrollment

Arms

50.9

Duration (Months)

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Allergic Rhinitis	Drug: Levocetirizine Drug: Desloratadine	Phase 4

Detailed Description

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

Study Design

Study Type:

Interventional

Actual Enrollment :

115 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

In Vivo Anti-inflammatory Effect of H1 Antihistamines in Allergic Rhinitis

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Nov 1, 2011

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: healthy volunteers healthy volunteers
Active Comparator: Desloratadine patients with allergic rhinitis under treatment with Desloratadine 5 mg/day, 4 weeks	Drug: Desloratadine administration of Desloratadine 5 mg/day for 4 weeks Other Names: Aerius
Active Comparator: Levocetirizine patients with allergic rhinitis under treatment with Levocetirizine 5 mg/day, 4 weeks	Drug: Levocetirizine administration of Levocetirizine 5 mg/day for 4 weeks Other Names: Xyzal

Arm

Intervention/Treatment

No Intervention: healthy volunteers

healthy volunteers

Active Comparator: Desloratadine

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

Drug: Desloratadine

administration of Desloratadine 5 mg/day for 4 weeks

Other Names:

Aerius

Active Comparator: Levocetirizine

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

Drug: Levocetirizine

administration of Levocetirizine 5 mg/day for 4 weeks

Other Names:

Xyzal

Outcome Measures

Primary Outcome Measures

efficacy of H1 antihistamines (patients evaluation) [4 weeks]
patients evaluation before and after 4-weeks treatment

Secondary Outcome Measures

asthma risk (incidence of asthma in patients with persistent allergic rhinitis after 1.5 years from study inclusion) [1.5 years]
incidence of asthma in patients with persistent allergic rhinitis after 1.5 years from study inclusion

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.