Titre du document / Document title

Comparison of cetirizine-pseudoephedrine and placebo in patients with seasonal allergic rhinitis and concomitant mild-to-moderate asthma : randomized, double-blind study

Auteur(s) / Author(s)

NATHAN Robert A. ⁽¹⁾ ; FINN Albert F. ⁽²⁾ ; LAFORCE Craig ⁽³⁾ ; RATNER Paul ⁽⁴⁾ ; CHAPMAN Douglass ⁽⁵⁾ ; DE GUIA Emilio C. ⁽⁵⁾ ; HEWLETT Dial ⁽⁵⁾ ; KRAMER Ben ⁽⁵⁾ ;

Affiliation(s) du ou des auteurs / Author(s) Affiliation(s)

⁽¹⁾ Asthma and Allergy Associates, Colorado Springs, Colorado, ETATS-UNIS
⁽²⁾ National Allergy, Asthma and Urticaria Centers, Charleston, South Carolina, ETATS-UNIS
⁽³⁾ North Carolina Clinical Research, Raleigh, North Carolina, ETATS-UNIS
⁽⁴⁾ Sylvania Research Associates, San Antonio, Texas, ETATS-UNIS
⁽⁵⁾ Pfizer Inc, New York, New York, ETATS-UNIS

Résumé / Abstract

Background: Allergic rhinitis (AR) and asthma are common concurrent conditions. Objectives: To evaluate the effects of cetirizine hydrochloride (5 mg)-pseudoephedrine hydrochloride (120 mg) (cetirizine-D) twice daily on AR and asthma symptoms, pulmonary function, and asthma-related quality of life in 274 patients with confirmed seasonal AR and concomitant mild-to-moderate asthma. Methods: In this multicenter, randomized, double-blind, placebo-controlled study, after a 1-week screening period, patients took cetirizine-D or placebo for 4 weeks. The primary efficacy variable, AR total symptom severity complex score, was derived from patient daily diary ratings of sneezing, runny nose, itchy nose, postnasal drip, and nasal congestion. Asthma symptom severity total scores were derived from twice-daily diary ratings of wheezing, coughing, shortness of breath, and chest tightness. Pulmonary function was tested at clinic visits and by patients each morning and evening. Patients completed the Asthma Quality of Life Questionnaire at each visit. All tests were 2-sided, with statistical significance at the .05 level. Results: Cetirizine-D reduced total symptom severity complex scores by 42.3% overall vs 23.6% with placebo (P <.001). Asthma symptom severity total scores were significantly improved with cetirizine-D at most times vs placebo. Cetirizine-D treatment was also associated with significantly improved Asthma Quality of Life Questionnaire overall scores. Pulmonary function test results were neutral. Cetirizine-D was well tolerated, with discontinuation and adverse event rates similar to placebo. Somnolence occurred in 8 patients (5.8%) taking cetirizine-D and in 1 (0.7%) taking placebo. Conclusions: Treatment with cetirizine-D twice daily significantly reduced rhinitis and asthma symptoms and improved overall asthma quality of life in patients with seasonal AR and concomitant mild-to-moderate asthma.

Revue / Journal Title

Annals of allergy, asthma, & immunology   ISSN 1081-1206 

Source / Source

2006, vol. 97, n^o3, pp. 389-396 [8 page(s) (article)] (24 ref.)

Langue / Language

Anglais

Editeur / Publisher

American College of Allergy, Asthma, & Immunology, McLean, VA, ETATS-UNIS  (1995) (Revue)

Mots-clés anglais / English Keywords

Lung disease ; Bronchus disease ; Obstructive pulmonary disease ; Respiratory disease ; Nose disease ; ENT disease ; Sympathomimetic ; α-Adrenergic receptor agonist ; α-Adrenergic receptor ; Agonist ; H1 Histamine receptor ; Piperazine derivatives ; Antihistaminic ; Antagonist ; Immunopathology ; Immunology ; Asthma ; Rhinitis ; Double blind study ; Allergy ; Randomization ; Human ; Pseudoephedrine ; Placebo ; Comparative study ; Cetirizine ;

Mots-clés français / French Keywords

Poumon pathologie ; Bronche pathologie ; Bronchopneumopathie obstructive ; Appareil respiratoire pathologie ; Nez pathologie ; ORL pathologie ; Sympathomimétique ; Stimulant α-adrénergique ; Récepteur α-adrénergique ; Agoniste ; Récepteur histaminergique H1 ; Pipérazine dérivé ; Antihistaminique ; Antagoniste ; Immunopathologie ; Immunologie ; Asthme ; Rhinite ; Etude double insu ; Allergie ; Randomisation ; Homme ; Pseudoéphédrine ; Placebo ; Etude comparative ; Cétirizine ;

Mots-clés espagnols / Spanish Keywords

Pulmón patología ; Bronquio patología ; Broncopneumopatía obstructiva ; Aparato respiratorio patología ; Nariz patología ; ORL patología ; Simpaticomimético ; Estimulante α-adrenérgico ; Receptor α-adrenérgico ; Agonista ; Receptor histaminérgico H1 ; Piperazina derivado ; Antihistamínico ; Antagonista ; Inmunopatología ; Inmunología ; Asma ; Rinitis ; Estudio doble ciego ; Alergia ; Aleatorización ; Hombre ; Pseudoefedrina ; Placebo ; Estudio comparativo ; Cetirizina ;

Localisation / Location

INIST-CNRS, Cote INIST : 5910, 35400015721294.0190