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Anti-inflammatory H1 Antihistamines Allergic Rhinitis

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ClinicalTrials.gov Identifier: NCT02507635
Recruitment Status : Completed
First Posted : July 24, 2015
Last Update Posted : July 24, 2015
Sponsor:
Information provided by (Responsible Party):
Stefan Cristian Vesa, Iuliu Hatieganu University of Medicine and Pharmacy

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

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Study Type : Interventional  (Clinical Trial)
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 : February 2009
Actual Primary Completion Date : November 2011
Actual Study Completion Date : May 2013

Resource links provided by the National Library of Medicine


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 Name: 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 Name: Xyzal




Primary Outcome Measures :
  1. efficacy of H1 antihistamines (patients evaluation) [ Time Frame: 4 weeks ]
    patients evaluation before and after 4-weeks treatment


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Stefan Cristian Vesa, Assistant professor, Iuliu Hatieganu University of Medicine and Pharmacy
ClinicalTrials.gov Identifier: NCT02507635    
Other Study ID Numbers: 535
First Posted: July 24, 2015    Key Record Dates
Last Update Posted: July 24, 2015
Last Verified: July 2015
Keywords provided by Stefan Cristian Vesa, Iuliu Hatieganu University of Medicine and Pharmacy:
cytokines
persistent allergic rhinitis
H1 antihistamines
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Respiratory Tract Infections
Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Levocetirizine
Desloratadine
Histamine H1 Antagonists, Non-Sedating
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cholinergic Antagonists
Cholinergic Agents