Trial | NCT02507635  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    115
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.
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 Started
Feb 28
2009
Primary Completion
Nov 30
2011
Study Completion
May 31
2013
Last Update
Jul 24
2015
Estimate

Drug Levocetirizine

administration of Levocetirizine 5 mg/day for 4 weeks

  • Other names: Xyzal

Drug Desloratadine

administration of Desloratadine 5 mg/day for 4 weeks

  • Other names: Aerius

healthy volunteers No Intervention

healthy volunteers

Desloratadine Active Comparator

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

Levocetirizine Active Comparator

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

Criteria 

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.
No Results Posted