Anti-inflammatory H1 Antihistamines Allergic Rhinitis
In Vivo Anti-inflammatory Effect of H1 Antihistamines in Allergic Rhinitis
1 other identifier
interventional
115
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2009
Longer than P75 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 17, 2015
CompletedFirst Posted
Study publicly available on registry
July 24, 2015
CompletedJuly 24, 2015
July 1, 2015
2.7 years
July 17, 2015
July 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
efficacy of H1 antihistamines (patients evaluation)
patients evaluation before and after 4-weeks treatment
4 weeks
Secondary Outcomes (1)
asthma risk (incidence of asthma in patients with persistent allergic rhinitis after 1.5 years from study inclusion)
1.5 years
Study Arms (3)
healthy volunteers
NO INTERVENTIONhealthy volunteers
Desloratadine
ACTIVE COMPARATORpatients with allergic rhinitis under treatment with Desloratadine 5 mg/day, 4 weeks
Levocetirizine
ACTIVE COMPARATORpatients with allergic rhinitis under treatment with Levocetirizine 5 mg/day, 4 weeks
Interventions
administration of Levocetirizine 5 mg/day for 4 weeks
administration of Desloratadine 5 mg/day for 4 weeks
Eligibility Criteria
You may qualify if:
- persistent allergic rhinitis
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 26740893DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant professor
Study Record Dates
First Submitted
July 17, 2015
First Posted
July 24, 2015
Study Start
February 1, 2009
Primary Completion
November 1, 2011
Study Completion
May 1, 2013
Last Updated
July 24, 2015
Record last verified: 2015-07