Comparison of the combinations of fexofenadine-pseudoephedrine and loratadine-montelukast in the treatment of seasonal allergic rhinitis

doi:10.1016/S1081-1206(10)61713-9

Annals of Allergy, Asthma & Immunology

Volume 92, Issue 1, January 2004, Pages 73-79

https://doi.org/10.1016/S1081-1206(10)61713-9 Get rights and content

Background

Antihistamine-decongestant combinations are used routinely for the treatment of seasonal allergic rhinitis. Recently, the combination of an antihistamine and a leukotriene receptor antagonist has been shown to be efficacious.

Objective

To compare the 2 combinations in the treatment of seasonal allergic rhinitis.

Methods

This was a randomized, double-blind, double-dummy, parallel study in which patients with seasonal allergic rhinitis received either fexofenadine, 60 mg, and pseudoephedrine, 120 mg, twice daily, or loratadine, 10 mg, and montelukast, 10 mg, once daily, for 2 weeks. The Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) was completed at the beginning and end of the study. Patients recorded nasal symptoms and measured nasal peak inspiratory flow (NPIF) twice daily. Baseline measurements were obtained before initiation of treatment.

Results

Compared with baseline, both treatments resulted in statistically and clinically meaningful reductions of overall and individual RQLQ domain scores (P < .01) except for the sleep domain, for which only loratadine-montelukast led to significant improvement. There was a significant reduction in total symptoms (P ≤ .05) compared with baseline on most treatment days in patients receiving both combinations. When the change from baseline was analyzed, there were no statistically significant differences in total symptoms between fexofenadine-pseudoephedrine and loratadine-montelukast (median, −28.5 vs −22.5; P = .33). There was a significant improvement in NPIF from baseline on all treatment days in both groups (P < .05), with no significant difference between treatments.

Conclusions

Fexofenadine-pseudoephedrine and loratadine-montelukast have comparable efficacy in improving symptoms, RQLQ scores, and nasal obstruction in seasonal allergic rhinitis. The lack of improvement in sleep in the fexofenadine-pseudoephedrine group is probably related to insomnia, a known adverse effect of pseudoephedrine.

REFERENCES (26)

MS Dykewicz et al.
Executive summary of joint task force practice parameters on diagnosis and management of rhinitis
Ann Allergy Asthma Immunol.
(1998)
J Bousquet et al.
Pathophysiology and treatment of seasonal allergic rhinitis
Respir Med.
(1990)
B Volovitz et al.
Leukotriene C4 release in upper respiratory mucosa during natural exposure to ragweed in ragweed-sensitive children
J Allergy Clin Immunol.
(1988)
F Horak et al.
Effect of desloratadine versus placebo on nasal airflow and subjective measures of nasal obstruction in subjects with grass pollen-induced allergic rhinitis in an allergen-exposure unit
J Allergy Clin Immunol.
(2002)
D Gentile et al.
Management of allergic rhinitis: antihistamines and decongestants
Immunol Allergy Clin North Am.
(2000)
EO Meltzer et al.
Concomitant monteleukast and loratadine as treatment for seasonal allergic rhinitis: a randomized, placebo-controlled clinical trial
J Allergy Clin Immunol.
(2000)
AS Nayak et al.
Efficacy and tolerability of montelukast along or in combination with loratadine in seasonal allergic rhinitis: a multicenter, randomized, double-blind, placebo-controlled trial performed in the fall
Ann Allergy Asthma Immunol.
(2002)
T Pullerits et al.
Comparison of a nasal glucocorticoid, antileukotriene, and a combination of antileukotriene and antihistamine in the treatment of seasonal allergic rhinitis
J Allergy Clin Immunol.
(2002)
J van Adelsberg et al.
Randomized controlled trial evaluating the clinical benefit of montelukast for treating spring seasonal allergic rhinitis
Ann Allergy Asthma Immunol.
(2003)
WW Storms
Rethinking our approach to allergic rhinitis management
Ann Allergy Asthma Immunol.
(2002)

E Bronsky et al.

Comparative efficacy and safety of a once-daily loratadine-pseudoephedrine combination versus its components alone and placebo in the management of seasonal allergic rhinitis

J Allergy Clin Immunol.

(1995)

R Evans

Epidemiology and natural history of asthma, allergic rhinitis, and atopic dermatitis.

RM Naclerio

Allergic rhinitis

N Engl J Med.

(1991)

Cited by (46)

Medications, drugs of abuse, and alcohol
2023, Encyclopedia of Sleep and Circadian Rhythms: Volume 1-6, Second Edition
Sleep is a very tightly regulated process that can be easily disturbed by medications, illicit drug use, or chronic alcohol abuse. Sleep complaints are very common among substance abusers and chronic alcoholics and consist mainly of insomnia with difficulty in falling and/or maintaining sleep. Sleep disruption might be long lasting and promote relapse to addiction or alcoholism. Early recognition and treatment of these sleep disorders might improve outcomes in this population as it is increasingly recognized that sleep is essential to maintain optimal health.
Quality of sleep in allergic children and their parents
2015, Allergologia et Immunopathologia
Citation Excerpt :
It should also be considered that some anti-allergic drugs, such as sedating antihistamines, can alter sleep due to their effect on the central nervous system.7 Nasal decongestants containing pseudoephedrine are, on the contrary, associated with insomnia.8 Several tools are available to subjectively assess the degree of impairment of sleep in these patients.9
Quality of sleep is essential for physical and mental health and influences the perception of the patient's well-being during the day. In patients with chronic allergic diseases sleep disorders may increase the severity of the condition, complicate the management and impair their quality of life. When children are concerned, their parents are also affected by the problem. We evaluated the presence of disrupted sleep in parents of children with atopic disorders, and its relationship with clinical features and the presence of disturbed sleep in children.
Parents of children suffering from allergic diseases were recruited from the Pediatric Allergy Units of Parma University. Evaluation of sleep in parents was based on the Pittsburg Sleep Quality Index (PSQI), while in children it was based on the Sleep Disturbance Scale for Children (SDSC).
Of the 102 parents invited, 92 filled in the questionnaire. Only the questionnaires with more than a 95% completion rate were considered for analysis. PSQI mean score in parents was 6.6 (SD 2.6); 75.6% of them had a PSQI ≥ 5, indicating that most parents had a sleep quality perceived as bad. The PSQI ≥ 5 was more common in parents of children with asthma and rhinitis. In children, SDSC mean score was 42.1 (SD: 9.4); 62.3% had a total score ≥ 39. The quality of sleep in parents and children was significantly correlated (p < 0.001).
These findings make it apparent that an alteration of sleep in children can also affect the parents. Such effect further weighs the burden of respiratory allergy and needs to be considered in future studies.
Sleep impairment and daytime sleepiness in patients with allergic rhinitis: The role of congestion and inflammation
2013, Annals of Allergy, Asthma and Immunology
Citation Excerpt :
Although the anticholinergic agent ipratropium bromide is not considered effective in relieving nasal congestion, there are limited data suggesting that its use in AR treatment may improve sleep and daily living.64 Leukotriene receptor antagonists65 or a combination of an antihistamine and a leukotriene receptor antagonist66 have shown some efficacy in improving sleep and quality of life in patients with AR and sleep-disordered breathing. The mechanisms responsible for improved sleep and decreased daytime somnolence may include congestion reduction, a decline in inflammatory mediators, or a combination of these.
To investigate the association of rhinitis with stress, fatigue, decrease productivity, inflammation, and sleep disordered breathing.
Medical literature obtained from OVID and PubMed searches in February 2013 using the search terms “sleep,” “rhinitis,” “allergic rhinitis,” “somnolence,” and “fatigue”.
Studies were selected based on the US Preventive Services Task Force levels 1, 2, and 3.
Allergic rhinitis is a disease that severely affects patients' quality of life and is increasing in prevalence worldwide. Nasal congestion is reported as the most common and bothersome symptom; it is often associated with sleep-disordered breathing, a likely cause of sleep impairment in rhinitis-affected individuals. The end result is a reduced quality of life and productivity and an increase in daytime sleepiness, fatigue, and stress. Current treatment modalities include intranasal corticosteroids, which have been found to reduce nasal congestion. Clinical trials on intranasal corticosteroids have provided data on sleep-related end points, and these studies report that the improved nasal congestion is associated with improved quality of life with better sleep and reduced daytime fatigue. Alternate therapies, including montelukast, also decrease nasal congestion and positively influence sleep, but to a lesser extent.
This review examines nasal congestion and cytokine changes and the associated sleep impairment in allergic rhinitis patients and the effect on daytime performance. It elaborates the adverse effects of disturbed sleep on quality of life and how therapies directed at reducing nasal congestion can relieve such effects.
Medications, Drugs of Abuse, and Alcohol
2013, Encyclopedia of Sleep
Sleep is a very tightly regulated process that can be easily disturbed by medications, illicit drug use, or chronic alcohol abuse. Sleep complaints are very common among substance abusers and chronic alcoholics and consist mainly of insomnia with difficulty in falling and/or maintaining sleep. Sleep disruption might be long lasting and promote relapse to addiction or alcoholism. Early recognition and treatment of these sleep disorders might improve outcomes in this population as it is increasingly recognized that sleep is essential to maintain optimal health.
Medications, Drugs of Abuse, and Alcohol
2013, Encyclopedia of Sleep
Sleep is a very tightly regulated process that can be easily disturbed by medications, illicit drug use, or chronic alcohol abuse. Sleep complaints are very common among substance abusers and chronic alcoholics and consist mainly of insomnia with difficulty in falling and/or maintaining sleep. Sleep disruption might be long lasting and promote relapse to addiction or alcoholism. Early recognition and treatment of these sleep disorders might improve outcomes in this population as it is increasingly recognized that sleep is essential to maintain optimal health.
Rhinitis and sleep
2011, Sleep Medicine Reviews
Citation Excerpt :
The anticholinergic agent ipratropium bromide is not considered effective in relieving nasal congestion24; however, limited data suggest that sleep and quality of life may be improved following treatment.85 Leukotriene receptor antagonists86,87 or a combination of an antihistamine and a leukotriene receptor antagonist88 have shown some efficacy in improving sleep and quality of life in patients with allergic rhinitis or sleep-disordered breathing. The cause of the improved sleep and daytime somnolence may be a reduction of congestion or a reduction of inflammatory mediators or a combination of both.
Allergic rhinitis is a very prevalent disease in developed nations and has been increasing throughout the world. Nasal congestion is one of the most common and bothersome symptoms of rhinitis in both children and adults. Congestion is associated with sleep-disordered breathing and is thought to be a key cause of sleep impairment in rhinitis. The end result is decrease in quality of life and productivity and increased daytime sleepiness.
Treatment with intranasal corticosteroids has been shown to reduce nasal congestion. Data on sleep-related endpoints from clinical trials of intranasal corticosteroids indicate that this reduction is associated with improved sleep, reduced daytime fatigue, and improved quality of life. Other therapies, such as montelukast, also have a positive influence on congestion and sleep, while still other therapies for rhinitis do not affect either symptom.
This review examines nasal congestion and the associated sleep impairment with allergic rhinitis. It explores the adverse effects of disturbed sleep on patients’ quality of life and how these disturbances can be reduced by therapies that address nasal congestion.

View all citing articles on Scopus

: Supported by grant AI 45583 from the National Institutes of Health, Bethesda, MD, and a grant-in-aid from Aventis Pharmaceuticals.

View full text

ORIGINAL ARTICLESComparison of the combinations of fexofenadine-pseudoephedrine and loratadine-montelukast in the treatment of seasonal allergic rhinitis

Background

Objective

Methods

Results

Conclusions

Ann Allergy Asthma Immunol.

Respir Med.

J Allergy Clin Immunol.

J Allergy Clin Immunol.

Immunol Allergy Clin North Am.

J Allergy Clin Immunol.

Ann Allergy Asthma Immunol.

J Allergy Clin Immunol.

Ann Allergy Asthma Immunol.

Ann Allergy Asthma Immunol.

J Allergy Clin Immunol.

Epidemiology and natural history of asthma, allergic rhinitis, and atopic dermatitis.

Allergic rhinitis

N Engl J Med.

ORIGINAL ARTICLES
Comparison of the combinations of fexofenadine-pseudoephedrine and loratadine-montelukast in the treatment of seasonal allergic rhinitis