Anti-inflammatory H1 Antihistamines Allergic Rhinitis

Allergic Rhinitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02507635
• Other study ID #: 535
• Status: Completed
• Phase: Phase 4
• First received: July 17, 2015
• Last updated: July 22, 2015
• Start date: February 2009
• Est. completion date: May 2013

Study information

• Verified date: July 2015
• Source: Iuliu Hatieganu University of Medicine and Pharmacy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Romania: National Agency for Medicines and Medical Devices
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: May 2013
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis

Intervention

Drug:
• Levocetirizine
administration of Levocetirizine 5 mg/day for 4 weeks
• Desloratadine
administration of Desloratadine 5 mg/day for 4 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Iuliu Hatieganu University of Medicine and Pharmacy

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	efficacy of H1 antihistamines (patients evaluation)	patients evaluation before and after 4-weeks treatment	4 weeks	No
Secondary	asthma risk (incidence of asthma in patients with persistent allergic rhinitis after 1.5 years from study inclusion)	incidence of asthma in patients with persistent allergic rhinitis after 1.5 years from study inclusion	1.5 years	No