Skip to main content
OpenTrials
Completed

NCT Number: NCT02507635

Anti-inflammatory H1 Antihistamines Allergic Rhinitis

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levocetirizine

Drug

administration of Levocetirizine 5 mg/day for 4 weeks

Other names: Xyzal

desloratadine

Drug

administration of Desloratadine 5 mg/day for 4 weeks

Other names: Aerius

Primary outcomes

  1. efficacy of H1 antihistamines (patients evaluation)

    Time frame: 4 weeks

    patients evaluation before and after 4-weeks treatment

Secondary outcomes

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

    Time frame: 1.5 years

    incidence of asthma in patients with persistent allergic rhinitis after 1.5 years from study inclusion

Sponsors and collaborators

Lead sponsor

Iuliu Hatieganu University of Medicine and Pharmacy

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Jul 24, 2015
Registry last updated
Jul 24, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.