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Anti-inflammatory H1 Antihistamines Allergic Rhinitis

Primary Purpose

Allergic Rhinitis

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Levocetirizine
Desloratadine
Sponsored by
Iuliu Hatieganu University of Medicine and Pharmacy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Allergic Rhinitis focused on measuring cytokines, persistent allergic rhinitis, H1 antihistamines

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    No Intervention

    Active Comparator

    Active Comparator

    Arm Label

    healthy volunteers

    Desloratadine

    Levocetirizine

    Arm Description

    healthy volunteers

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

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

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    July 17, 2015
    Last Updated
    July 22, 2015
    Sponsor
    Iuliu Hatieganu University of Medicine and Pharmacy
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02507635
    Brief Title
    Anti-inflammatory H1 Antihistamines Allergic Rhinitis
    Official Title
    In Vivo Anti-inflammatory Effect of H1 Antihistamines in Allergic Rhinitis
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2015
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2009 (undefined)
    Primary Completion Date
    November 2011 (Actual)
    Study Completion Date
    May 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Iuliu Hatieganu University of Medicine and Pharmacy

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Allergic Rhinitis
    Keywords
    cytokines, persistent allergic rhinitis, H1 antihistamines

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    115 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    healthy volunteers
    Arm Type
    No Intervention
    Arm Description
    healthy volunteers
    Arm Title
    Desloratadine
    Arm Type
    Active Comparator
    Arm Description
    patients with allergic rhinitis under treatment with Desloratadine 5 mg/day, 4 weeks
    Arm Title
    Levocetirizine
    Arm Type
    Active Comparator
    Arm Description
    patients with allergic rhinitis under treatment with Levocetirizine 5 mg/day, 4 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Levocetirizine
    Other Intervention Name(s)
    Xyzal
    Intervention Description
    administration of Levocetirizine 5 mg/day for 4 weeks
    Intervention Type
    Drug
    Intervention Name(s)
    Desloratadine
    Other Intervention Name(s)
    Aerius
    Intervention Description
    administration of Desloratadine 5 mg/day for 4 weeks
    Primary Outcome Measure Information:
    Title
    efficacy of H1 antihistamines (patients evaluation)
    Description
    patients evaluation before and after 4-weeks treatment
    Time Frame
    4 weeks
    Secondary Outcome Measure Information:
    Title
    asthma risk (incidence of asthma in patients with persistent allergic rhinitis after 1.5 years from study inclusion)
    Description
    incidence of asthma in patients with persistent allergic rhinitis after 1.5 years from study inclusion
    Time Frame
    1.5 years

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility 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.

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    26740893
    Citation
    Bocsan CI, Bujor AI, Miron N, Vesa SC, Deleanu D, Buzoianu AD. In Vivo Anti-Inflammatory Effect of H1 Antihistamines in Allergic Rhinitis: A Randomized Clinical Trial. Balkan Med J. 2015 Oct;32(4):352-8. doi: 10.5152/balkanmedj.2015.15884. Epub 2015 Oct 1.
    Results Reference
    derived

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    Anti-inflammatory H1 Antihistamines Allergic Rhinitis

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