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
|Condition or disease||Intervention/treatment||Phase|
|Allergic Rhinitis||Drug: Levocetirizine Drug: Desloratadine||Phase 4|
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||115 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
No Intervention: healthy volunteers
Active Comparator: Desloratadine
patients with allergic rhinitis under treatment with Desloratadine 5 mg/day, 4 weeks
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
administration of Levocetirizine 5 mg/day for 4 weeks
Other Name: Xyzal
- efficacy of H1 antihistamines (patients evaluation) [ Time Frame: 4 weeks ]patients evaluation before and after 4-weeks treatment
- 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