Comparison of cetirizine-pseudoephedrine and placebo in patients with seasonal allergic rhinitis and concomitant mild-to-moderate asthma: randomized, double-blind study.
BACKGROUND
Allergic rhinitis (AR) and asthma are common concurrent conditions.


OBJECTIVE
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.
Nathan
Robert A
RA
Asthma and Allergy Associates, Colorado Springs 80907, USA. DrRNathan@aol.com
Finn
Albert F
AF
LaForce
Craig
C
Ratner
Paul
P
Chapman
Douglass
D
de Guia
Emilio C
EC
Hewlett
Dial
D
Kramer
Ben
B
D018663:Adrenergic Agents / Q000627:therapeutic use; D000328:Adult; D018927:Anti-Asthmatic Agents / Q000627:therapeutic use; D001249:Asthma / Q000150:complications* / Q000188:drug therapy*; D017332:Cetirizine / Q000627:therapeutic use*; D004338:Drug Combinations; D004809:Ephedrine / Q000627:therapeutic use*; D005260:Female; D039563:Histamine H1 Antagonists, Non-Sedating / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D011788:Quality of Life; D012129:Respiratory Function Tests; D006255:Rhinitis, Allergic, Seasonal / Q000150:complications* / Q000188:drug therapy; D011795:Surveys and Questionnaires
D018663:Adrenergic Agents; D018927:Anti-Asthmatic Agents; D004338:Drug Combinations; D039563:Histamine H1 Antagonists, Non-Sedating; D004809:Ephedrine; D017332:Cetirizine