Failure of montelukast to reduce sputum eosinophilia in high-dose corticosteroid-dependent asthma

Jayaram, Lata

doi:10.1183/09031936.04.00008104

Cited by 37 publications

(19 citation statements)

References 33 publications

(40 reference statements)

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“…Antileukotrienes (montelukast, 10 mg for 4 weeks) have been tested in CD asthma but did not prevent sputum eosinophilia, although this was in a small number of subjects. 234 …”

Section: Management Of Glucocorticoid Resistancementioning

confidence: 97%

Update on glucocorticoid action and resistance

Ito

Chung

Adcock

2006

Journal of Allergy and Clinical Immunology

350

312

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“…Antileukotrienes (montelukast, 10 mg for 4 weeks) have been tested in CD asthma but did not prevent sputum eosinophilia, although this was in a small number of subjects. 234 …”

Section: Management Of Glucocorticoid Resistancementioning

confidence: 97%

Update on glucocorticoid action and resistance

Ito

Chung

Adcock

2006

Journal of Allergy and Clinical Immunology

350

312

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“…Treatment with corticosteroids consistently decreases sputum eosinophils. 87,88 Although leukotriene receptor antagonists have been shown to reduce sputum eosinophils, 89 these effects are not consistent 88 and are smaller compared with those of corticosteroids 90,91 or omalizumab. 92 Long- or short-acting β-adrenergic agonists are not thought to alter sputum eosinophilia.…”

Section: Review Of Specific Core and Supplemental Biomarker Outcomesmentioning

confidence: 99%

Asthma outcomes: Biomarkers

Szefler¹,

Wenzel²,

Brown³

et al. 2012

Journal of Allergy and Clinical Immunology

350

287

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Background Measurement of biomarkers has been incorporated within clinical research studies of asthma to characterize the population and associate the disease with environmental and therapeutic effects. Objective National Institutes of Health institutes and federal agencies convened an expert group to propose which biomarkers should be assessed as standardized asthma outcomes in future clinical research studies. Methods We conducted a comprehensive search of the literature to identify studies that developed and/or tested asthma biomarkers. We identified biomarkers relevant to the underlying disease process progression and response to treatment. We classified the biomarkers as either core (required in future studies), supplemental (used according to study aims and standardized), or emerging (requiring validation and standardization). This work was discussed at an National Institutes of Health–organized workshop convened in March 2010 and finalized in September 2011. Results Ten measures were identified; only 1, multiallergen screening to define atopy, is recommended as a core asthma outcome. Complete blood counts to measure total eosinophils, fractional exhaled nitric oxide (Feno), sputum eosinophils, urinary leukotrienes, and total and allergen-specific IgE are recommended as supplemental measures. Measurement of sputum polymorphonuclear leukocytes and other analytes, cortisol measures, airway imaging, breath markers, and system-wide studies (eg, genomics, proteomics) are considered as emerging outcome measures. Conclusion The working group participants propose the use of multiallergen screening in all asthma clinical trials to characterize study populations with respect to atopic status. Blood, sputum, and urine specimens should be stored in biobanks, and standard procedures should be developed to harmonize sample collection for clinical trial biorepositories.

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“…Reporting of sample size calculation Of the 361 search results, 20 studies fulfilled the inclusion criteria [9,[13][14][15][16][17][18][19][20][21][22][23][24][25][26][27][28][29][30][31][32]. 11 of the 20 (55%) did not report how the sample size was calculated.…”

Section: Resultsmentioning

confidence: 99%

Sample sizes for clinical trials using sputum eosinophils as a primary outcome

et al. 2013

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Clinical trials do not report sputum eosinophil data in a consistent method and this makes it difficult to compare across studies and to evaluate the sample sizes estimated in these studies. The objectives of the paper are: 1) to systematically review reporting of effect size and sample calculations in randomised controlled trials using sputum eosinophil count as a primary outcome and 2) to illustrate sample size estimation under different methods of data representation using data from an effective anti-eosinophil treatment strategy (mepolizumab).Randomised controlled trials in adults (excluding allergen provocation models) of treatment of asthma and chronic obstructive pulmonary disease for the past 10 years were searched in Ovid MEDLINE and 20 studies were identified that met all the inclusion criteria. Only nine studies discussed sample size calculation.Change from baseline was used as an outcome in 11 studies and was expressed as change in absolute percentage count, percentage change from baseline or as fold changes.Assuming a minimal clinically important reduction of 15% in absolute terms, 18 subjects in each arm will be required to achieve 80% power using an ANCOVA analysis, which we recommend, to detect significance with an alpha error of 0.05. @ERSpublications Systematic review and illustration of sample size calculations in RCTs using sputum eosinophil count as a primary outcome

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Failure of montelukast to reduce sputum eosinophilia in high-dose corticosteroid-dependent asthma

Cited by 37 publications

References 33 publications

Update on glucocorticoid action and resistance

Update on glucocorticoid action and resistance

Asthma outcomes: Biomarkers

Sample sizes for clinical trials using sputum eosinophils as a primary outcome

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