Asthma, rhinitis, other respiratory diseasesFluticasone propionate/salmeterol combination provides more effective asthma control than low-dose inhaled corticosteroid plus montelukast☆,☆☆
Section snippets
Patient selection
Male and female patients aged 15 years and older were eligible if they had had asthma for at least 6 months and if they had been taking low-to-moderate doses of an ICS for at least 30 days before screening. This included BDP 252 to 420 μg/d, budesonide 400 μg/d, flunisolide 1000 μg/d, FP 176 to 220 μg/d, or triamcinolone acetonide 600 to 800 μg/d. At the screening visit, all patients were required to have a forced expiratory volume in 1 second (FEV1) between 50% and 80% of the predicted normal
Results
In total, 447 patients (87% of whom were white and 92% of whom had had asthma for ≥ 5 years) were randomly assigned to double-blind treatment: 222 in the FP/Salm Combo group and 225 in the FP + montelukast group. The treatment groups were comparable with respect to age, sex, and pulmonary function at screening and the end of run-in (Table I).
Empty Cell FP/Salm Combo FP + Montelukast No. of patients 222 225 Age (y) Mean (SD) 40.2 (14.4) 43.0 (13.7) Range 15-79
Discussion
This study demonstrated that patients whose symptoms were suboptimally controlled with ICS therapy alone had significantly greater improvement in asthma control and significantly fewer asthma exacerbations when their treatment was switched to FP/Salm Combo through the Diskus inhaler than when montelukast was added to low-dose FP therapy.
No significant differences were observed between treatment groups for wheeze, chest tightness, and overall symptoms. However, the patient-reported symptom
Acknowledgements
We thank Amy Schaberg for her assistance with preparation and editing of this manuscript.
References (40)
- et al.
Diskus and Diskhaler: efficacy and safety of fluticasone propionate via two dry powder inhalers in subjects with mild-to-moderate persistent asthma
Ann Allergy Asthma Immunol
(1999) - et al.
Inhaled fluticasone propionate delivered by means of two different multidose powder inhalers is effective and safe in a large pediatric population with persistent asthma
J Allergy Clin Immunol
(1998) - et al.
Fluticasone propionate powder: oral corticosteroid-sparing effect and improved lung function and quality of life in patients with severe chronic asthma
J Allergy Clin Immunol
(1999) - et al.
Added salmeterol versus higher-dose corticosteroid in asthma patients with symptoms on existing inhaled corticosteroid
Lancet
(1994) - et al.
The addition of salmeterol to fluticasone propionate versus increasing the dose of fluticasone propionate in patients with persistent asthma
Ann Allergy Asthma Immunol
(1999) - et al.
Salmeterol/fluticasone propionate (50/500microg) in combination in a Diskus inhaler (Seretide) is effective and safe in the treatment of steroid-dependent asthma
Respir Med
(1999) - et al.
Salmeterol and fluticasone propionate combined in a new powder inhalation device for the treatment of asthma: a randomized, double-blind, placebo-controlled trial
J Allergy Clin Immunol
(2000) - et al.
Alternative agents for anti-inflammatory treatment of asthma
J Allergy Clin Immunol
(1998) - et al.
The combination of salmeterol and low-dose fluticasone versus higher-dose fluticasone: an analysis of asthma exacerbations (abstract 494)
J Allergy Clin Immunol
(2000) - et al.
Comparison of inhaled salmeterol and oral zafirlukast in patients with asthma
J Allergy Clin Immunol
(1999)
Inhaled salmeterol and fluticasone: a study comparing monotherapy and combination therapy in asthma
Ann Allergy Asthma Immunol
Fluticasone alone or in combination with salmeterol vs triamcinolone acetonide in asthma
Chest
Effect of salmeterol on patient’s adherence to their prescribed refills for inhaled corticosteroids
Ann Allergy Asthma Immunol
National Asthma Education and Prevention Program. Guidelines for the diagnosis and management of asthma. Expert panel report II
A study on the clinical equivalence and patient preference of fluticasone propionate 250 microg twice daily via the Diskus/Accuhaler inhaler or the Diskhaler inhaler in adult asthmatic patients
J Asthma
Comparison of the addition of salmeterol to inhaled steroids with doubling of the dose of inhaled steroids
Am J Respir Crit Care Med
Addition of salmeterol versus doubling the dose of fluticasone propionate in patients with mild to moderate asthma
Thorax
Salmeterol added to inhaled corticosteroid therapy is superior to doubling the dose of inhaled corticosteroids: a randomized clinical trial
J Asthma
Concurrent use of salmeterol with inhaled corticosteroids is more effective than inhaled corticosteroid dose increases
Allergy Asthma Proc
Salmeterol and fluticasone propionate (50/250 microg) administered via combination Diskus inhaler: as effective as when given via separate Diskus inhalers
Can Respir J
Cited by (215)
Executive summary: Japanese guidelines for adult asthma (JGL) 2021
2023, Allergology InternationalAsthma
2022, Allergy EssentialsJapanese guidelines for adult asthma 2020
2020, Allergology InternationalCurrent state and future prospect of the therapeutic strategy targeting cysteinyl leukotriene metabolism in asthma
2019, Respiratory InvestigationA study of inhalation drugs in the management of asthma in northern parts of Tamilnadu
2019, Materials Today: ProceedingsJapanese guidelines for adult asthma 2017
2017, Allergology InternationalCitation Excerpt :ICSs plus LABAs are considered to be more effective than moderate doses of ICS monotherapy.75 If the patients cannot use LABAs, LTRA,41,76 or sustained-release theophylline49 can be used instead. Early treatment with ICS/LABA can rapidly improve asthmatic symptoms and pulmonary function, as compared with ICS monotherapy.75,77
- ☆
Supported by a grant from Glaxo Wellcome Inc, Research Triangle Park, NC.
- ☆☆
Reprint requests: Harold S. Nelson, MD, National Jewish Medical and Research Center, 1400 Jackson St, Denver, CO 80206.