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Anti-inflammatory H1 Antihistamines Allergic Rhinitis

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02507635
Enrollment
115
Registered
2015-07-24
Start date
2009-02-28
Completion date
2013-05-31
Last updated
2015-07-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Allergic Rhinitis

Keywords

cytokines, persistent allergic rhinitis, H1 antihistamines

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.

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

Interventions

DRUGLevocetirizine

administration of Levocetirizine 5 mg/day for 4 weeks

DRUGDesloratadine

administration of Desloratadine 5 mg/day for 4 weeks

Sponsors

Iuliu Hatieganu University of Medicine and Pharmacy
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frameDescription
efficacy of H1 antihistamines (patients evaluation)4 weekspatients evaluation before and after 4-weeks treatment

Secondary

MeasureTime frameDescription
asthma risk (incidence of asthma in patients with persistent allergic rhinitis after 1.5 years from study inclusion)1.5 yearsincidence of asthma in patients with persistent allergic rhinitis after 1.5 years from study inclusion

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026