Anti-inflammatory H1 Antihistamines Allergic Rhinitis
Primary Purpose
Allergic Rhinitis
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Levocetirizine
Desloratadine
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis focused on measuring cytokines, persistent allergic rhinitis, H1 antihistamines
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.
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
NCT ID
NCT02507635
First Posted
July 17, 2015
Last Updated
July 22, 2015
Sponsor
Iuliu Hatieganu University of Medicine and Pharmacy
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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