Montelukast as Add-On Therapy with Inhaled Corticosteroids Alone or Inhaled Corticosteroids and Long-Acting Beta-2-Agonists in the Management of Patients Diagnosed with Asthma and Concurrent Allergic Rhinitis (the RADAR Trial)

OBJECTIVE: To evaluate the effectiveness of montelukast as add-on therapy for patients diagnosed with asthma and concurrent allergic rhinitis who remain uncontrolled while receiving inhaled corticosteroid (ICS) monotherapy or ICS/long-acting beta-2-agonist (LABA) therapy in a community practice setting.DESIGN: An eight-week, multicentre, open-label, observational study. Patients were 15 years of age or older and, while treated with an ICS or ICS/LABA, had allergic rhinitis and uncontrolled asthma symptoms by at least two criteria as per the Canadian Asthma Consensus Guidelines. The primary outcome measure was the percentage of patients with controlled asthma symptoms after eight weeks of treatment with montelukast 10 mg once daily added to ICS or ICS/LABA therapy.RESULTS: In total, 1004 patients participated in the survey phase of the study. Of these patients, 319 continued in the treatment phase and 301 (94.4%) completed the eight-week assessment. At baseline, all patients had uncontrolled asthma symptoms based on the Canadian Asthma Consensus Guidelines; at the eight-week assessment, 229 patients (76.1%) achieved asthma control. According to the Asthma Control Questionnaire (as determined by scores of 0.75 or less), 164 patients (54.7%) achieved well-controlled asthma at week 8. The mean (± SD) Asthma Control Questionnaire score decreased from 2.03±0.80 to 0.92±0.80 (P<0.001) for all patients, representing a clinically significant improvement. A statistically and clinically significant reduction in the overall Mini Rhinitis Quality of Life Questionnaire score was achieved with a decrease from 2.57±1.20 to 1.12±1.00 (–1.45±1.35; P<0.001). Patient and physician satisfaction rates with montelukast add-on therapy were also significantly increased when compared with baseline treatment.CONCLUSION: Montelukast add-on therapy is effective for managing asthma and allergic rhinitis symptoms in patients who were previously uncontrolled with ICS or ICS/LABA treatment.

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Montelukast as Add-On Therapy to Inhaled Corticosteroids in the Management of Asthma (the SAS trial)

Canadian Respiratory Journal ◽

10.1155/2009/326043 ◽

2009 ◽

Vol 16 (suppl a) ◽

pp. 5A-10A ◽

Cited By ~ 2

Author(s):

J Mark Fitzgerald ◽

Sylvain Foucart ◽

Stephen Coyle ◽

John Sampalis ◽

Denis Haine ◽

...

Keyword(s):

Asthma Control ◽

Inhaled Corticosteroids ◽

Inhaled Corticosteroid ◽

Uncontrolled Asthma ◽

Open Label ◽

Asthma Control Questionnaire ◽

Asthmatic Patients ◽

The Mean ◽

Clinically Significant ◽

High Doses

AIM: To evaluate the effectiveness of montelukast as add-on therapy for asthmatic patients who remain uncontrolled with low, moderate or high doses of inhaled corticosteroid monotherapy.DESIGN: An eight-week, multicentre, open-label, observational study.RESULTS: Of 320 patients enrolled, 288 (90.0%) completed the study. Of patients who had uncontrolled asthma symptoms (Canadian Asthma Consensus Guidelines Update, 2003) but were controlled according to the Asthma Control Questionnaire (ACQ score of less than 1.5), 93.9% maintained asthma control at week 8. Of patients with uncontrolled asthma at baseline for both definitions, 63.5% achieved asthma control by week 8. The mean ± SD ACQ score decreased from 1.13±0.28 to 0.57±0.50 (P<0.001) for controlled patients at baseline and from 2.38±0.73 to 1.03±0.80 (P<0.001) for patients who were uncontrolled at baseline, each representing a clinically significant improvement.CONCLUSION: Montelukast add-on therapy is an effective alternative to inhaled corticosteroid monotherapy.

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Montelukast as Add-On Therapy to Inhaled Corticosteroids in the Management of Asthma (The SAS Trial)

Canadian Respiratory Journal ◽

10.1155/2009/593753 ◽

2009 ◽

Vol 16 (suppl a) ◽

pp. 5A-10A ◽

Cited By ~ 13

Author(s):

J Mark FitzGerald ◽

Sylvain Foucart ◽

Stephen Coyle ◽

John Sampalis ◽

Denis Haine ◽

...

Keyword(s):

Asthma Control ◽

Inhaled Corticosteroids ◽

Inhaled Corticosteroid ◽

Uncontrolled Asthma ◽

Open Label ◽

Asthma Control Questionnaire ◽

Asthmatic Patients ◽

The Mean ◽

Clinically Significant ◽

High Doses

AIM: To evaluate the effectiveness of montelukast as add-on therapy for asthmatic patients who remain uncontrolled with low, moderate or high doses of inhaled corticosteroid monotherapy.DESIGN: An eight-week, multicentre, open-label, observational study.RESULTS: Of 320 patients enrolled, 288 (90.0%) completed the study. Of patients who had uncontrolled asthma symptoms (Canadian Asthma Consensus Guidelines Update, 2003) but were controlled according to the Asthma Control Questionnaire (ACQ score of less than 1.5), 93.9% maintained asthma control at week 8. Of patients with uncontrolled asthma at baseline for both definitions, 63.5% achieved asthma control by week 8. The mean ± SD ACQ score decreased from 1.13±0.28 to 0.57±0.50 (P<0.001) for controlled patients at baseline and from 2.38±0.73 to 1.03±0.80 (P<0.001) for patients who were uncontrolled at baseline, each representing a clinically significant improvement.CONCLUSION: Montelukast add-on therapy is an effective alternative to inhaled corticosteroid monotherapy.

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Asthma control in adult patients treated with a combination of inhaled corticosteroids and long-acting beta-2 agonists: a prospective observational study

Polish Archives of Internal Medicine ◽

10.20452/pamw.3899 ◽

2017 ◽

Author(s):

Barbara Rogala ◽

Paweł Majak ◽

Joanna Glück ◽

Tomasz Dębowski

Keyword(s):

Observational Study ◽

Asthma Control ◽

Prospective Observational Study ◽

Inhaled Corticosteroids ◽

Adult Patients ◽

Beta 2 ◽

Long Acting

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Evaluation of Asthma Control by Physicians and Patients: Comparison with Current Guidelines

Canadian Respiratory Journal ◽

10.1155/2002/731804 ◽

2002 ◽

Vol 9 (6) ◽

pp. 417-423 ◽

Cited By ~ 90

Author(s):

Louis-Philippe Boulet ◽

Robert Phillips ◽

Paul O’Byrne ◽

Allan Becker

Keyword(s):

Asthma Control ◽

Airflow Obstruction ◽

Ordinal Scale ◽

Consensus Guidelines ◽

Uncontrolled Asthma ◽

Treatment Needs ◽

Night Time ◽

Asthma Control Questionnaire ◽

Current Asthma ◽

Current Guidelines

BACKGROUND:Current asthma consensus guidelines recommend a series of criteria for determining whether asthma is controlled. It is not known whether physicians are using these criteria to assess treatment needs and how effective such assessments are compared with patient assessment of asthma control.OBJECTIVE: To compare the parameters used by physicians and patients with asthma to determine whether asthma control is acceptable, according to the current Canadian asthma consensus guidelines.DATA AND METHODS: A total of 183 Canadian physicians, mostly general practitioners, evaluated 856 patients with mildly to moderately uncontrolled asthma who were not using anti-inflammatory medications at the time of entry in the study. Physician characteristics and patient demographics were obtained. The physicians completed two questionnaires, one assessing the level of asthma control of the patient on an ordinal scale from 1 (very poor) to 5 (very good) and another indicating the parameters that were used to evaluate this level of control. Patients answered an asthma control questionnaire identical to the one completed by the physician and completed a six-question asthma control questionnaire, with each question scored on a 0- to 6-point scale.RESULTS: Although according to current asthma guidelines all patients surveyed had uncontrolled asthma, 66.2% of patients and 43.3% of physicians rated control of asthma symptoms as adequate to very good. The average scores for patient- and physician-rated asthma control were 3.0±0.2 and 2.6±0.2, respectively. The average patient score on the Juniper asthma questionnaire was 12.2±6.3. Physicians used a mean of seven parameters to assess the patient’s level of asthma control, mostly beta2-agonist need, followed by cough, wheezing, shortness of breath, limitation of physical activities and night-time awakenings. Pediatricians used cough more frequently as an evaluation parameter, and respirologists measured pulmonary function more often than other physcians. Some parameters not usually included in guideline criteria for control, such as fatigue, need to clear throat, colored sputum, headache and dizziness, were sometimes used by physicians. Only 10% and 18% of physicians used measurements of forced expiratory volume in 1 s and peak expiratory flow, respectively, in asthma control assessments.CONCLUSIONS: The present study shows that the selection of asthma control criteria among physicians varies and is not always in keeping with current asthma guidelines. Both patients and physicians often consider asthma to be controlled, when according to current guidelines, it is not, and patients consider their asthma better controlled than do physicians. Objective measures of airflow obstruction are rarely used to assess asthma control. The present study stresses the need for improved dissemination - to both patients and physicians - of current recommendations on how asthma control should be determined.

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Is a low level of education a limiting factor for asthma control in a population with access to pulmonologists and to treatment?

Jornal Brasileiro de Pneumologia ◽

10.1590/1806-3713/e20180052 ◽

2019 ◽

Vol 45 (1) ◽

Author(s):

Cassia Caroline Emilio ◽

Cintia Fernanda Bertagni Mingotti ◽

Paula Regina Fiorin ◽

Leydiane Araujo Lima ◽

Raisa Lemos Muniz ◽

...

Keyword(s):

Risk Factor ◽

Asthma Control ◽

Treatment Adherence ◽

Limiting Factor ◽

Inhaler Technique ◽

Uncontrolled Asthma ◽

Asthma Control Questionnaire ◽

Level Of Education ◽

Low Level ◽

Asthma Symptoms

ABSTRACT Objective: To determine whether a low level of education is a risk factor for uncontrolled asthma in a population of patients who have access to pulmonologists and to treatment. Methods: This was a cross-sectional study involving outpatients > 10 years of age diagnosed with asthma who were followed by a pulmonologist for at least 3 months in the city of Jundiai, located in the state of São Paulo, Brazil. The patients completed a questionnaire specifically designed for this study, the 6-item Asthma Control Questionnaire (to assess the control of asthma symptoms), and a questionnaire designed to assess treatment adherence. Patients underwent spirometry, and patient inhaler technique was assessed. Results: 358 patients were enrolled in the study. Level of education was not considered a risk factor for uncontrolled asthma symptoms (OR = 0.99; 95% CI: 0.94-1.05), spirometry findings consistent with obstructive lung disease (OR = 1.00; 95% CI: 0.99-1.01), uncontrolled asthma (OR = 1.03; 95% CI: 0.95-1.10), or the need for moderate/high doses of inhaled medication (OR = 0.99; 95% CI: 0.94-1.06). The number of years of schooling was similar between the patients in whom treatment adherence was good and those in whom it was poor (p = 0.08), as well as between those who demonstrated proper inhaler technique and those who did not (p = 0.41). Conclusions: Among asthma patients with access to pulmonologists and to treatment, a low level of education does not appear to be a limiting factor for adequate asthma control.

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Effectiveness of, Adherence to and Satisfaction with Montelukast Treatment in Allergic Rhinitis Patients with Uncontrolled Asthma Symptoms while on Treatment with Low Dose Inhaled Corticosteroids

Journal of Allergy and Clinical Immunology ◽

10.1016/j.jaci.2006.12.326 ◽

2007 ◽

Vol 119 (1) ◽

pp. S244-S245

Author(s):

C. Koch ◽

A. Kaplan ◽

J. Sampalis ◽

E. Psaradellis ◽

A. McIvor

Keyword(s):

Allergic Rhinitis ◽

Low Dose ◽

Inhaled Corticosteroids ◽

Uncontrolled Asthma ◽

Asthma Symptoms

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Comparing the Asthma Control and Anti-inflammatory Effects of Different Fixed Combinations of Inhaled Corticosteroids Plus Long-acting Beta 2 Agonist; A Randomized Clinical Trial

Open Access Macedonian Journal of Medical Sciences ◽

10.3889/oamjms.2021.6548 ◽

2021 ◽

Vol 9 (B) ◽

pp. 771-778

Author(s):

Ashraf Elsayed Sileem ◽

Ahmed Ali ◽

Hanan Elnahas ◽

Ahmed M. Gouda

Keyword(s):

Clinical Trial ◽

Randomized Clinical Trial ◽

Asthma Control ◽

Severe Asthma ◽

Inhaled Corticosteroids ◽

Treated Group ◽

Fixed Dose ◽

Beta 2 ◽

Hs Crp ◽

Long Acting

Background: Asthma is the most common chronic inflammatory disease of the pulmonary system. The prevalence of asthma is growing enormously worldwide posing a significant health and economic burden. Asthma treatment guidelines recommend a combination of inhaled corticosteroid (ICS) and long-acting beta 2 agonist (LABA). However, there is little guidance for clinicians on selecting a specific ICS/LABA combination. Aim: To compare the effectiveness of three fixed dose ICS/LABA combination therapies i.e., fluticasone/salmeterol, fluticasone/formoterol and budesonide/formoterol for the management of moderate to severe asthma. Design: This was a prospective interventional, three-armed, parallel group, open label, and randomized clinical trial Methods: Adult asthmatic patients of both genders (n=135) were randomly allocated to the three ICS/LABA treatment groups: fluticasone/salmeterol-treated group (n=45) , fluticasone/formoterol-treated group (n=45) and budesonide/formoterol-treated group (n=45). All groups were treated for three months. The main outcome parameters included lung function (FEV1, FEV1%, FEV1/FVC), inflammatory state (hs-CRP, ECP) and asthma control (ACT). Results: After 3 months of treatment, fluticasone/formoterol significantly increased FEV1 compared to fluticasone/salmeterol (p<0.01) and FEV1% compared to budesonide/formoterol (p<0.01). Both fluticasone-containing combinations significantly increased FEV1/FVC (p<0.001, p<0.001), decreased serum hs-CRP (p<0.01, p<0.001), and serum ECP (p<0.05, p<0.001) and improved ACT (p<0.05, p<0.01) compared to budesonide. Fluticasone/formoterol significantly reduced ECP in comparison to fluticasone/salmeterol (p<0.05). Conclusion: Our study showed a superiority for fluticasone-containing combinations over budesonide for the treatment of moderate to severe asthma. Within the former combinations, fluticasone/formoterol was better than fluticasone/salmeterol.

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