Efficacy and safety of levocetirizine in improving symptoms and health-related quality of life in US adults with seasonal allergic rhinitis: a randomized, placebo-controlled study

Segall, Nathan; Gawchik, Sandra M.; Georges, George; Haeusler, Jean-Marc C.

doi:10.1016/j.anai.2009.12.003

Cited by 26 publications

(34 citation statements)

References 24 publications

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“…nasal obstruction, rhinorrhoea, nasal itching, sneezing, and ocular complaints, on a scale of 0–3 [Total 5 Symptom Score (T5SS) [13,14]; 0 = symptom not present; 1 = mild, symptom present but not bothersome; 2 = moderate, symptom bothersome but easily tolerated, and 3 = severe, symptom difficult to tolerate] at a clinical screening visit and each evening for a week. Patients with a screening and daily mean T5SS ≥8 (range 0–15) and a nasal obstruction score ≥2 (range 0–3) were assessed for the presence and severity of sleep disorders using PSG.…”

Section: Methodsmentioning

confidence: 99%

Assessment of Sleep Impairment in Persistent Allergic Rhinitis Patients Using Polysomnography

Meng¹,

Xuan²,

Qiao³

et al. 2010

Int Arch Allergy Immunol

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Background: Although questionnaires have demonstrated an association between impairment of quality of sleep and symptoms in allergic rhinitis (AR) patients, to date there is no report of an objective assessment of sleep in patients with persistent allergic rhinitis (PER) as defined by ARIA guidelines. The aim of the present study was therefore to assess sleep disturbance in PER patients by polysomnography (PSG). Methods: Ninety-eight PER patients with moderate-to-severe nasal obstruction and 30 healthy volunteers were included in the study. All patients underwent PSG during nocturnal sleep to assess the presence and severity of sleep disorders. Peak nasal inspiratory flow (PNIF) was also measured to assess nasal resistance. Results: There were statistically significant, though clinically modest, differences between PER patients and healthy controls in most PSG parameters including sleep efficiency, arousal index, average SaO₂, lowest SaO₂, time spent with a saturation below 90%, and snoring time. Although the apnea-hypopnea index (AHI) was not significantly different between the 2 groups, 17 subjects (17.3%) in the PER group but none of the control subjects had an AHI >5. Patients with higher T5SS scores (12 ≤ T5SS ≤ 15) had a greater tendency to snore than did patients with lower scores (8 ≤ T5SS ≤ 11). Finally, PNIF in the PER group was significantly lower than in the control group. Weak correlations between the arousal index and PNIF, average SaO₂, and PNIF were found. Conclusion: PSG showed modest changes in PER patients versus control subjects.

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Section: Methodsmentioning

confidence: 99%

Assessment of Sleep Impairment in Persistent Allergic Rhinitis Patients Using Polysomnography

Meng¹,

Xuan²,

Qiao³

et al. 2010

Int Arch Allergy Immunol

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“…Structurally, levocetirizine belongs to the diphenylpiperazine class of compounds with selective H 1 -antagonist effects. It has excellent efficacy and a favorable safety profile with low metabolism and an absence of cardiac side effects when coadministered with liver enzyme-inhibiting drugs (4,5). Levocetirizine shows higher binding affinity for human H 1 histamine receptor by about 30-fold compared with dextrocetirizine, the S-enantiomer of racemic cetirizine (6,7).…”

Section: Levocetirizine (2-[2-[4-[(r)-(4-chlorophenyl)phenylmethyl]-pmentioning

confidence: 99%

Determination of Levocetirizine in Human Plasma by LC–MS-MS: Validation and Application in a Pharmacokinetic Study

Wichitnithad

Jithavech²,

Sanphanya³

et al. 2015

Journal of Chromatographic Science

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A fast and simple sample cleanup approach for levocetirizine in human was developed using protein precipitation coupled with LC-MS-MS. Samples were treated with 6% trichloroacetic acid in water prior to LC-MS-MS analysis. Chromatographic separation was performed on a reverse phase column with an isocratic mobile phase of acetonitrile and 10 mM ammonium formate pH 3.5 (80:20, v/v) at a flow rate of 1.0 mL/min. The run time was 3.5 min. Mass parameters were optimized to monitor transitions at m/z [M+H] + 389.0→201.0 for levocetirizine and m/z [M+H] + 375.3→201.0 for hydroxyzine as internal standard. The lower limit of quantification and the dynamic range were 1.00 and 1.00-500 ng/mL, respectively. Linearity was good for intraday and interday validations (r 2 ≥ 0.995). The mean recoveries were 59 and 69% for levocetirizine and hydroxyzine, respectively. Matrix effect was acceptable with %CV < 15. Hemolytic effect was negligible. Levocetirizine was stable in human plasma for 27 h at room temperature (25°C), for 16 weeks frozen at −70°C, 4 weeks frozen at −20°C, for 24 h in an autosampler at 15°C and for three freeze/thaw cycles. The validated method was applied in a pharmacokinetic study to determine the concentration of levocetirizine in plasma samples. The study provides a fast and simple bioanalytical method for routine analysis and may be particularly useful for bioequivalence studies.

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“…It assesses function-related end points, providing a measure of the economic impact of allergic rhinitis and the potential of therapeutic interventions [49]. The medical treatment of rhinitis has been found to improve work productivity in persistent and also seasonal allergic rhinitis using this tool [50,51].…”

Section: ) Generic Questionnairesmentioning

confidence: 99%

Health-Related Quality of Life and Rhinitis Control Measures in Allergic Rhinitis

Makatsori

Koulias

Calderón

2014

Curr Treat Options Allergy

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Efficacy and safety of levocetirizine in improving symptoms and health-related quality of life in US adults with seasonal allergic rhinitis: a randomized, placebo-controlled study

Cited by 26 publications

References 24 publications

Assessment of Sleep Impairment in Persistent Allergic Rhinitis Patients Using Polysomnography

Assessment of Sleep Impairment in Persistent Allergic Rhinitis Patients Using Polysomnography

Determination of Levocetirizine in Human Plasma by LC–MS-MS: Validation and Application in a Pharmacokinetic Study

Health-Related Quality of Life and Rhinitis Control Measures in Allergic Rhinitis

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