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Article ; Online: Researching asthma across the ages: insights from the National Heart, Lung, and Blood Institute's Asthma Network.

Cabana, Michael D / Kunselman, Susan J / Nyenhuis, Sharmilee M / Wechsler, Michael E

The Journal of allergy and clinical immunology

2013 Volume 133, Issue 1, Page(s) 27–33

Abstract: Clinical asthma studies across different age groups (ie, cross-age studies) can potentially offer insight into the similarities, differences, and relationships between childhood and adult asthma. The National Institutes of Health's Asthma Research ... ...

Abstract	Clinical asthma studies across different age groups (ie, cross-age studies) can potentially offer insight into the similarities, differences, and relationships between childhood and adult asthma. The National Institutes of Health's Asthma Research Network (AsthmaNet) is unique and innovative in that it has merged pediatric and adult asthma research into a single clinical research network. This combination enhances scientific exchange between pediatric and adult asthma investigators and encourages the application of cross-age studies that involve participants from multiple age groups who are generally not studied together. The experience from AsthmaNet in the development of cross-age protocols highlights some of the issues in the evaluation of cross-age research in asthma. The aim of this review is to summarize these challenges, including the selection of parallel cross-age clinical interventions, identification of appropriate controls, measurement of meaningful clinical outcomes, and various ethical and logistic issues.
MeSH term(s)	Adult ; Age Factors ; Anti-Asthmatic Agents/therapeutic use ; Asthma/drug therapy ; Child ; Female ; Humans ; Male ; National Heart, Lung, and Blood Institute (U.S.) ; Population Groups ; Treatment Outcome ; United States
Chemical Substances	Anti-Asthmatic Agents
Language	English
Publishing date	2013-12-23
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Review
ZDB-ID	121011-7
ISSN	1097-6825 ; 1085-8725 ; 0091-6749
ISSN (online)	1097-6825 ; 1085-8725
ISSN	0091-6749
DOI	10.1016/j.jaci.2013.10.026
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Article ; Online: Vitamin D3 treatment of vitamin D-insufficient asthmatic patients does not alter immune cell function.

Reid, Brandy / Girodet, Pierre-Olivier / Boomer, Jonathan S / Abdel-Gadir, Azza / Zheng, Kathy / Wechsler, Michael E / Bacharier, Leonard B / Kunselman, Susan J / King, Tonya S / Israel, Elliot / Castro, Mario / Cernadas, Manuela / Green, Jonathan M

The Journal of allergy and clinical immunology

2016 Volume 138, Issue 1, Page(s) 286–289.e9

MeSH term(s)	Adrenal Cortex Hormones/therapeutic use ; Asthma/complications ; Asthma/drug therapy ; Asthma/immunology ; Asthma/metabolism ; CD4-Positive T-Lymphocytes/drug effects ; CD4-Positive T-Lymphocytes/immunology ; Cholecalciferol/therapeutic use ; Dendritic Cells/drug effects ; Dendritic Cells/immunology ; Gene Expression ; Humans ; Interferon-gamma/genetics ; Interferon-gamma/immunology ; Interleukins/genetics ; Interleukins/immunology ; Monocytes/drug effects ; Monocytes/immunology ; Transforming Growth Factor beta/genetics ; Transforming Growth Factor beta/immunology ; Tumor Necrosis Factor-alpha/genetics ; Tumor Necrosis Factor-alpha/immunology ; Vitamin D Deficiency/complications ; Vitamin D Deficiency/drug therapy ; Vitamin D Deficiency/immunology ; Vitamin D Deficiency/metabolism
Chemical Substances	Adrenal Cortex Hormones ; IFNG protein, human ; Interleukins ; Transforming Growth Factor beta ; Tumor Necrosis Factor-alpha ; Cholecalciferol (1C6V77QF41) ; Interferon-gamma (82115-62-6)
Language	English
Publishing date	2016-02-10
Publishing country	United States
Document type	Letter ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural
ZDB-ID	121011-7
ISSN	1097-6825 ; 1085-8725 ; 0091-6749
ISSN (online)	1097-6825 ; 1085-8725
ISSN	0091-6749
DOI	10.1016/j.jaci.2015.11.030
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Article: Differential release of cardiac enzymes after percutaneous coronary intervention.

Matthews, Mark A / Kunselman, Susan J / Gascho, Joseph A / Gilchrist, Ian C

Catheterization and cardiovascular interventions : official journal of the Society for Cardiac Angiography & Interventions

2005 Volume 65, Issue 1, Page(s) 19–24

Abstract: We hypothesized that using calcium channel blockers (CCBs) that dilate microvasculature during percutaneous coronary intervention (PCI) would result in lower postprocedural creatine phosphokinase (CPK). PCI can be complicated by elevated CPK that has ... ...

Abstract	We hypothesized that using calcium channel blockers (CCBs) that dilate microvasculature during percutaneous coronary intervention (PCI) would result in lower postprocedural creatine phosphokinase (CPK). PCI can be complicated by elevated CPK that has been associated with impaired microvascular perfusion. Nitroglycerin (NTG), the conventional PCI vasodilator, dilates epicardial arteries but does not affect the microvasculature. We hypothesized that using CCBs that dilate the microvasculature would result in lower postprocedural CPK values. Patients (n = 816) without evidence of acute myonecrosis undergoing PCI were divided into two groups based on whether they received intracoronary NTG or CCB during PCI. Postprocedural CPK values were compared using a repeated-measures ANOVA and a random coefficient model. By repeated-measures analysis, the NTG group had CPK values of 88%, 83%, and 89% of the CCB group's CPK values at < 8, 8-14, and > 14 hr after PCI (P = 0.0080, 0.0002, and 0.0244), respectively. In a random coefficient model, the NTG group had CPK values 84%, 84%, and 89% of the CCB group's mean CPK values at 6, 12, and 18 hr after PCI (P = 0.0003, 0.0006, and 0.0403), respectively. Peak CPK values occurred earlier with CCB, although the maximal CPK was similar in both groups. Intracoronary CCB use is associated with an accelerated release of CPK after PCI compared with NTG. This is consistent with more efficient relief of microvascular obstruction with CCB. It suggests that myonecrosis may originate with vascular trauma at the time of PCI and its enzymatic expression is modifiable with different vasodilators.
MeSH term(s)	Angioplasty, Balloon, Coronary ; Biomarkers/blood ; Calcium Channel Blockers/administration & dosage ; Calcium Channel Blockers/therapeutic use ; Coronary Vessels/drug effects ; Coronary Vessels/physiopathology ; Creatine Kinase/blood ; Female ; Follow-Up Studies ; Humans ; Injections, Intra-Arterial ; Male ; Middle Aged ; Myocardial Ischemia/enzymology ; Myocardial Ischemia/physiopathology ; Myocardial Ischemia/therapy ; Myocardium/enzymology ; Nitroglycerin/administration & dosage ; Nitroglycerin/therapeutic use ; Prospective Studies ; Treatment Outcome ; Vasodilation/drug effects ; Vasodilator Agents/administration & dosage ; Vasodilator Agents/therapeutic use
Chemical Substances	Biomarkers ; Calcium Channel Blockers ; Vasodilator Agents ; Creatine Kinase (EC 2.7.3.2) ; Nitroglycerin (G59M7S0WS3)
Language	English
Publishing date	2005-05
Publishing country	United States
Document type	Comparative Study ; Journal Article
ZDB-ID	1459995-8
ISSN	1522-726X ; 1522-1946
ISSN (online)	1522-726X
ISSN	1522-1946
DOI	10.1002/ccd.20365
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Article: Factors affecting surgical risk in elderly patients with inflammatory bowel disease.

Page, Michael J / Poritz, Lisa S / Kunselman, Susan J / Koltun, Walter A

Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract

2001 Volume 6, Issue 4, Page(s) 606–613

Abstract: The operative treatment of elderly patients with inflammatory bowel disease (IBD) has often been avoided in favor of medical management because of a perceived increase in surgical risk. This study sought to define the following in the elderly IBD patient ...

Abstract	The operative treatment of elderly patients with inflammatory bowel disease (IBD) has often been avoided in favor of medical management because of a perceived increase in surgical risk. This study sought to define the following in the elderly IBD patient population: (1) the risk of surgical management and (2) those factors affecting risk. Thirty patients with IBD, aged 60 years or more, who were surgically managed by a single surgeon over a 10-year period, were retrospectively matched to 75 patients with IBD who were less than 60 years of age; patients were matched according to sex, date of surgery, and type of surgery performed. Regression analysis using generalized estimating equation methodology to account for the matched clusters of patients was performed to evaluate the effect of age group on the complication rate, operating room time, and length of hospital stay. Presence of comorbid conditions, surgical indications, prior surgery for IBD, and the use of immunosuppressive medications were studied in multivariate models, adjusting for age group. By means of univariate analysis, the odds of complications in elderly IBD patients were shown to be statistically higher than the odds seen in younger patients (47% vs. 20%, P = 0.01). Also observed in the elderly group were a longer length of hospital stay (11.5 days vs. 7.1 days, P = 0.001) and longer operating room time (249 minutes vs. 212 minutes, P = 0.02). Multivariate analysis revealed that the effect of age remained statistically significant, even when adjusted for potential confounding variables such as comorbidity, medications, date of diagnosis of IBD, and indications for surgery. The complication outcome was significantly associated with the surgical indication, with obstruction, fistula, and bleeding having increased odds of complications as compared with other indications (odds ratio = 1.7 vs. 4.2 vs. 7.2, respectively, P = 0.02). The length of hospital stay similarly was significantly associated with the surgical indication (fistula, 10.5 days vs. bleeding, 9.8 days vs. obstruction, 7.4 days vs. other, 9.3 days; P = 0.04) and a history of prior surgery. A significant interaction for length of hospital stay was present between age group and prior surgery status (with prior surgery: old, 18 days vs. young, 6.4 days, P = 0.0001; without prior surgery: old, 9.5 days vs. young 7.3 days, P = 0.10). Elderly patients with IBD have an increased rate of postoperative complications along with an increased length of hospital stay and increased operating room time. This effect of age persists when adjusted for comorbidity and immunosuppressive therapy. Complications are most dependent on surgical indications, with obstruction being the least and bleeding the worst predictive factors. The longest hospital stay is associated with patients who require surgery for fistulous disease and patients who have undergone previous surgery. The fact that the higher complication rate seen in older patients with IBD is associated with disease-defined surgical indications suggests that IBD in elderly patients may be more aggressive than what is observed in younger individuals.
MeSH term(s)	Adolescent ; Adult ; Age Factors ; Aged ; Aged, 80 and over ; Digestive System Surgical Procedures/adverse effects ; Female ; Humans ; Inflammatory Bowel Diseases/complications ; Inflammatory Bowel Diseases/surgery ; Male ; Middle Aged ; Retrospective Studies ; Risk Factors
Language	English
Publishing date	2001-06-26
Publishing country	United States
Document type	Journal Article
ZDB-ID	2012365-6
ISSN	1934-3213 ; 1873-4626 ; 1091-255X
ISSN (online)	1934-3213 ; 1873-4626
ISSN	1091-255X
DOI	10.1016/s1091-255x(01)00060-9
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Article ; Online: Pharmacogenetic studies of long-acting beta agonist and inhaled corticosteroid responsiveness in randomised controlled trials of individuals of African descent with asthma.

Ortega, Victor E / Daya, Michelle / Szefler, Stanley J / Bleecker, Eugene R / Chinchilli, Vernon M / Phipatanakul, Wanda / Mauger, Dave / Martinez, Fernando D / Herrera-Luis, Esther / Pino-Yanes, Maria / Hawkins, Gregory A / Ampleford, Elizabeth J / Kunselman, Susan J / Cox, Corey / Bacharier, Leonard B / Cabana, Michael D / Cardet, Juan Carlos / Castro, Mario / Denlinger, Loren C /

Eng, Celeste / Fitzpatrick, Anne M / Holguin, Fernando / Hu, Donglei / Jackson, Daniel J / Jarjour, Nizar / Kraft, Monica / Krishnan, Jerry A / Lazarus, Stephen C / Lemanske, Robert F / Lima, John J / Lugogo, Njira / Mak, Angel / Moore, Wendy C / Naureckas, Edward T / Peters, Stephen P / Pongracic, Jacqueline A / Sajuthi, Satria P / Seibold, Max A / Smith, Lewis J / Solway, Julian / Sorkness, Christine A / Wenzel, Sally / White, Steven R / Burchard, Esteban G / Barnes, Kathleen / Meyers, Deborah A / Israel, Elliot / Wechsler, Michael E

The Lancet. Child & adolescent health

2021 Volume 5, Issue 12, Page(s) 862–872

Abstract: Background: Pharmacogenetic studies in asthma cohorts, primarily made up of White people of European descent, have identified loci associated with response to inhaled beta agonists and corticosteroids (ICSs). Differences exist in how individuals from ... ...

Abstract	Background: Pharmacogenetic studies in asthma cohorts, primarily made up of White people of European descent, have identified loci associated with response to inhaled beta agonists and corticosteroids (ICSs). Differences exist in how individuals from different ancestral backgrounds respond to long-acting beta agonist (LABA) and ICSs. Therefore, we sought to understand the pharmacogenetic mechanisms regulating therapeutic responsiveness in individuals of African descent. Methods: We did ancestry-based pharmacogenetic studies of children (aged 5-11 years) and adolescents and adults (aged 12-69 years) from the Best African Response to Drug (BARD) trials, in which participants with asthma uncontrolled with low-dose ICS (fluticasone propionate 50 μg in children, 100 μg in adolescents and adults) received different step-up combination therapies. The hierarchal composite outcome of pairwise superior responsiveness in BARD was based on asthma exacerbations, a 31-day difference in annualised asthma-control days, or a 5% difference in percentage predicted FEV Findings: We included 249 unrelated children and 267 unrelated adolescents and adults in the BARD pharmacogenetic analysis. In children, we identified a significant admixture mapping peak for superior responsiveness to 5 × ICS versus 100 μg fluticasone plus salmeterol on chromosome 12 (odds ratio [OR Interpretation: BARD is the first genome-wide pharmacogenetic study of LABA and ICS response in clinical trials of individuals of African descent to detect and replicate genome-wide significant loci. Admixture mapping of the composite BARD trial outcome enabled the identification of novel pharmacogenetic variation accounting for differential therapeutic responses in people of African descent with asthma. Funding: National Institutes of Health, National Heart, Lung, and Blood Institute.
MeSH term(s)	Administration, Inhalation ; Adolescent ; Adrenal Cortex Hormones/therapeutic use ; Adult ; Asthma/drug therapy ; Asthma/ethnology ; Black People ; Bronchodilator Agents/therapeutic use ; Child ; Drug Therapy, Combination ; Female ; Fluticasone/therapeutic use ; Humans ; Male ; Middle Aged ; Pharmacogenomic Testing ; Salmeterol Xinafoate/therapeutic use ; United States ; Young Adult
Chemical Substances	Adrenal Cortex Hormones ; Bronchodilator Agents ; Salmeterol Xinafoate (6EW8Q962A5) ; Fluticasone (CUT2W21N7U)
Language	English
Publishing date	2021-11-09
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ISSN	2352-4650
ISSN (online)	2352-4650
DOI	10.1016/S2352-4642(21)00268-6
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Article ; Online: Step-Up Therapy in Black Children and Adults with Poorly Controlled Asthma.

Wechsler, Michael E / Szefler, Stanley J / Ortega, Victor E / Pongracic, Jacqueline A / Chinchilli, Vernon / Lima, John J / Krishnan, Jerry A / Kunselman, Susan J / Mauger, David / Bleecker, Eugene R / Bacharier, Leonard B / Beigelman, Avraham / Benson, Mindy / Blake, Kathryn V / Cabana, Michael D / Cardet, Juan-Carlos / Castro, Mario / Chmiel, James F / Covar, Ronina /

Denlinger, Loren / DiMango, Emily / Fitzpatrick, Anne M / Gentile, Deborah / Grossman, Nicole / Holguin, Fernando / Jackson, Daniel J / Kumar, Harsha / Kraft, Monica / LaForce, Craig F / Lang, Jason / Lazarus, Stephen C / Lemanske, Robert F / Long, Dayna / Lugogo, Njira / Martinez, Fernando / Meyers, Deborah A / Moore, Wendy C / Moy, James / Naureckas, Edward / Olin, J Tod / Peters, Stephen P / Phipatanakul, Wanda / Que, Loretta / Raissy, Hengameh / Robison, Rachel G / Ross, Kristie / Sheehan, William / Smith, Lewis J / Solway, Julian / Sorkness, Christine A / Sullivan-Vedder, Lisa / Wenzel, Sally / White, Steven / Israel, Elliot

The New England journal of medicine

2019 Volume 381, Issue 13, Page(s) 1227–1239

Abstract: Background: Morbidity from asthma is disproportionately higher among black patients than among white patients, and black patients constitute the minority of participants in trials informing treatment. Data indicate that patients with inadequately ... ...

Abstract	Background: Morbidity from asthma is disproportionately higher among black patients than among white patients, and black patients constitute the minority of participants in trials informing treatment. Data indicate that patients with inadequately controlled asthma benefit more from addition of a long-acting beta-agonist (LABA) than from increased glucocorticoids; however, these data may not be informative for treatment in black patients. Methods: We conducted two prospective, randomized, double-blind trials: one involving children and the other involving adolescents and adults. In both trials, the patients had at least one grandparent who identified as black and had asthma that was inadequately controlled with low-dose inhaled glucocorticoids. We compared combinations of therapy, which included the addition of a LABA (salmeterol) to an inhaled glucocorticoid (fluticasone propionate), a step-up to double to quintuple the dose of fluticasone, or both. The treatments were compared with the use of a composite measure that evaluated asthma exacerbations, asthma-control days, and lung function; data were stratified according to genotypic African ancestry. Results: When quintupling the dose of fluticasone (to 250 μg twice a day) was compared with adding salmeterol (50 μg twice a day) and doubling the fluticasone (to 100 μg twice a day), a superior response occurred in 46% of the children with quintupling the fluticasone and in 46% of the children with doubling the fluticasone and adding salmeterol (P = 0.99). In contrast, more adolescents and adults had a superior response to added salmeterol than to an increase in fluticasone (salmeterol-low-dose fluticasone vs. medium-dose fluticasone, 49% vs. 28% [P = 0.003]; salmeterol-medium-dose fluticasone vs. high-dose fluticasone, 49% vs. 31% [P = 0.02]). Neither the degree of African ancestry nor baseline biomarkers predicted a superior response to specific treatments. The increased dose of inhaled glucocorticoids was associated with a decrease in the ratio of urinary cortisol to creatinine in children younger than 8 years of age. Conclusions: In contrast to black adolescents and adults, almost half the black children with poorly controlled asthma had a superior response to an increase in the dose of an inhaled glucocorticoid and almost half had a superior response to the addition of a LABA. (Funded by the National Heart, Lung, and Blood Institute; BARD ClinicalTrials.gov number, NCT01967173.).
MeSH term(s)	Administration, Inhalation ; Adolescent ; Adrenergic beta-2 Receptor Agonists/administration & dosage ; Adult ; African Americans ; Asthma/drug therapy ; Bronchodilator Agents/administration & dosage ; Child ; Child, Preschool ; Cross-Over Studies ; Dose-Response Relationship, Drug ; Double-Blind Method ; Drug Combinations ; Female ; Fluticasone/administration & dosage ; Glucocorticoids/administration & dosage ; Humans ; Male ; Prospective Studies ; Salmeterol Xinafoate/administration & dosage
Chemical Substances	Adrenergic beta-2 Receptor Agonists ; Bronchodilator Agents ; Drug Combinations ; Glucocorticoids ; Salmeterol Xinafoate (6EW8Q962A5) ; Fluticasone (CUT2W21N7U)
Language	English
Publishing date	2019-09-26
Publishing country	United States
Document type	Comparative Study ; Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural
ZDB-ID	207154-x
ISSN	1533-4406 ; 0028-4793
ISSN (online)	1533-4406
ISSN	0028-4793
DOI	10.1056/NEJMoa1905560
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Article ; Online: Effects of inhaled fluticasone on upper airway during sleep and wakefulness in asthma: a pilot study.

Journal of clinical sleep medicine : JCSM : official publication of the American Academy of Sleep Medicine

2014 Volume 10, Issue 2, Page(s) 183–193

Abstract: Study objective: Obstructive sleep apnea is prevalent among people with asthma, but underlying mechanisms remain unknown. Inhaled corticosteroids may contribute. We tested the effects of orally inhaled fluticasone propionate (FP) on upper airway (UAW) ... ...

Abstract	Study objective: Obstructive sleep apnea is prevalent among people with asthma, but underlying mechanisms remain unknown. Inhaled corticosteroids may contribute. We tested the effects of orally inhaled fluticasone propionate (FP) on upper airway (UAW) during sleep and wakefulness. Study design: 16-week single-arm study. Participants: 18 (14 females, mean [ ± SD] age 26 ± 6 years) corticosteroid-naïve subjects with mild asthma (FEV1 89 ± 8% predicted). Interventions: High dose (1,760 mcg/day) inhaled FP. Measurements: (1) UAW collapsibility (passive critical closing pressure [Pcrit]); (2) tongue strength (maximum isometric pressure-Pmax, in KPa) and endurance-time (in seconds) able to maintain 50% Pmax across 3 trials (Ttot)-at anterior and posterior locations; (3) fat fraction and volume around UAW, measured by magnetic resonance imaging in three subjects. Results: Pcrit overall improved (became more negative) (mean ± SE) (-8.2 ± 1.1 vs. -12.2 ± 2.2 cm H2O, p = 0.04); the response was dependent upon baseline characteristics, with older, male gender, and worse asthma control predicting Pcrit deterioration (less negative). Overall, Pmax increased (anterior p = 0.02; posterior p = 0.002), but Ttot generally subsided (anterior p = 0.0007; posterior p = 0.06), unrelated to Pcrit response. In subjects studied with MRI, fat fraction and volume increased by 20.6% and 15.4%, respectively, without Pcrit changes, while asthma control appeared improved. Conclusions: In this study of young, predominantly female, otherwise healthy subjects with well-controlled asthma and stiff upper airways, 16-week high dose FP treatment elicited Pcrit changes which may be dependent upon baseline characteristics, and determined by synchronous and reciprocally counteracting local and lower airway effects. The long-term implications of these changes on sleep disordered breathing severity remain to be determined.
MeSH term(s)	Administration, Inhalation ; Adult ; Age Factors ; Airway Obstruction/complications ; Airway Obstruction/drug therapy ; Androstadienes/administration & dosage ; Androstadienes/pharmacology ; Asthma/complications ; Asthma/drug therapy ; Bronchodilator Agents/administration & dosage ; Bronchodilator Agents/pharmacology ; Female ; Fluticasone ; Humans ; Male ; Pilot Projects ; Polysomnography/drug effects ; Polysomnography/methods ; Sex Factors ; Sleep/physiology ; Sleep Apnea, Obstructive/complications ; Wakefulness/physiology
Chemical Substances	Androstadienes ; Bronchodilator Agents ; Fluticasone (CUT2W21N7U)
Language	English
Publishing date	2014-02-15
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2397213-0
ISSN	1550-9397 ; 1550-9389
ISSN (online)	1550-9397
ISSN	1550-9389
DOI	10.5664/jcsm.3450
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Article ; Online: Predictors of response to tiotropium versus salmeterol in asthmatic adults.

Peters, Stephen P / Bleecker, Eugene R / Kunselman, Susan J / Icitovic, Nikolina / Moore, Wendy C / Pascual, Rodolfo / Ameredes, Bill T / Boushey, Homer A / Calhoun, William J / Castro, Mario / Cherniack, Reuben M / Craig, Timothy / Denlinger, Loren C / Engle, Linda L / Dimango, Emily A / Israel, Elliot / Kraft, Monica / Lazarus, Stephen C / Lemanske, Robert F /

Lugogo, Njira / Martin, Richard J / Meyers, Deborah A / Ramsdell, Joe / Sorkness, Christine A / Sutherland, E Rand / Wasserman, Stephen I / Walter, Michael J / Wechsler, Michael E / Chinchilli, Vernon M / Szefler, Stanley J

The Journal of allergy and clinical immunology

2013 Volume 132, Issue 5, Page(s) 1068–1074.e1

Abstract: Background: Tiotropium has activity as an asthma controller. However, predictors of a positive response to tiotropium have not been described.: Objective: We sought to describe individual and differential responses of asthmatic patients to salmeterol ...

Abstract	Background: Tiotropium has activity as an asthma controller. However, predictors of a positive response to tiotropium have not been described. Objective: We sought to describe individual and differential responses of asthmatic patients to salmeterol and tiotropium when added to an inhaled corticosteroid, as well as predictors of a positive clinical response. Methods: Data from the double-blind, 3-way, crossover National Heart, Lung, and Blood Institute's Asthma Clinical Research Network's Tiotropium Bromide as an Alternative to Increased Inhaled Glucocorticoid in Patients Inadequately Controlled on a Lower Dose of Inhaled Corticosteroid (ClinicalTrials.gov number, NCT00565266) trial were analyzed for individual and differential treatment responses to salmeterol and tiotropium and predictors of a positive response to the end points FEV1, morning peak expiratory flow (PEF), and asthma control days (ACDs). Results: Although approximately equal numbers of patients showed a differential response to salmeterol and tiotropium in terms of morning PEF (n = 90 and 78, respectively) and ACDs (n = 49 and 53, respectively), more showed a differential response to tiotropium for FEV1 (n = 104) than salmeterol (n = 62). An acute response to a short-acting bronchodilator, especially albuterol, predicted a positive clinical response to tiotropium for FEV1 (odds ratio, 4.08; 95% CI, 2.00-8.31; P < .001) and morning PEF (odds ratio, 2.12; 95% CI, 1.12-4.01; P = 0.021), as did a decreased FEV1/forced vital capacity ratio (FEV1 response increased 0.39% of baseline for every 1% decrease in FEV1/forced vital capacity ratio). Higher cholinergic tone was also a predictor, whereas ethnicity, sex, atopy, IgE level, sputum eosinophil count, fraction of exhaled nitric oxide, asthma duration, and body mass index were not. Conclusion: Although these results require confirmation, predictors of a positive clinical response to tiotropium include a positive response to albuterol and airway obstruction, factors that could help identify appropriate patients for this therapy.
MeSH term(s)	Adrenergic beta-2 Receptor Agonists/therapeutic use ; Adult ; Albuterol/analogs & derivatives ; Albuterol/therapeutic use ; Anti-Asthmatic Agents/therapeutic use ; Asthma/diagnosis ; Asthma/drug therapy ; Bronchodilator Agents/therapeutic use ; Cross-Over Studies ; Female ; Humans ; Male ; Middle Aged ; Prognosis ; Salmeterol Xinafoate ; Scopolamine Derivatives/therapeutic use ; Tiotropium Bromide ; Treatment Outcome
Chemical Substances	Adrenergic beta-2 Receptor Agonists ; Anti-Asthmatic Agents ; Bronchodilator Agents ; Scopolamine Derivatives ; Salmeterol Xinafoate (6EW8Q962A5) ; Albuterol (QF8SVZ843E) ; Tiotropium Bromide (XX112XZP0J)
Language	English
Publishing date	2013-09-29
Publishing country	United States
Document type	Clinical Trial ; Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	121011-7
ISSN	1097-6825 ; 1085-8725 ; 0091-6749
ISSN (online)	1097-6825 ; 1085-8725
ISSN	0091-6749
DOI	10.1016/j.jaci.2013.08.003
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Article: Predictors of response to tiotropium versus salmeterol in asthmatic adults

Peters, Stephen P / Bleecker, Eugene R / Kunselman, Susan J / Icitovic, Nikolina / Moore, Wendy C / Pascual, Rodolfo / Ameredes, Bill T / Boushey, Homer A / Calhoun, William J / Castro, Mario / Cherniack, Reuben M / Craig, Timothy / Denlinger, Loren C / Engle, Linda L / DiMango, Emily A / Israel, Elliot / Kraft, Monica / Lazarus, Stephen C / Lemanske, Robert F., Jr /

Lugogo, Njira / Martin, Richard J / Meyers, Deborah A / Ramsdell, Joe / Sorkness, Christine A / Sutherland, E. Rand / Wasserman, Stephen I / Walter, Michael J / Wechsler, Michael E / Chinchilli, Vernon M / Szefler, Stanley J

The Journal of Allergy and Clinical Immunology. 2013 Nov., v. 132, no. 5

2013

Abstract: BACKGROUND: Tiotropium has activity as an asthma controller. However, predictors of a positive response to tiotropium have not been described. OBJECTIVE: We sought to describe individual and differential responses of asthmatic patients to salmeterol and ... ...

Institution	National Heart, Lung, and Blood Institute's Asthma Clinical Research Network
Abstract	BACKGROUND: Tiotropium has activity as an asthma controller. However, predictors of a positive response to tiotropium have not been described. OBJECTIVE: We sought to describe individual and differential responses of asthmatic patients to salmeterol and tiotropium when added to an inhaled corticosteroid, as well as predictors of a positive clinical response. METHODS: Data from the double-blind, 3-way, crossover National Heart, Lung, and Blood Institute's Asthma Clinical Research Network’s Tiotropium Bromide as an Alternative to Increased Inhaled Glucocorticoid in Patients Inadequately Controlled on a Lower Dose of Inhaled Corticosteroid (ClinicalTrials.gov number, NCT00565266) trial were analyzed for individual and differential treatment responses to salmeterol and tiotropium and predictors of a positive response to the end points FEV1, morning peak expiratory flow (PEF), and asthma control days (ACDs). RESULTS: Although approximately equal numbers of patients showed a differential response to salmeterol and tiotropium in terms of morning PEF (n = 90 and 78, respectively) and ACDs (n = 49 and 53, respectively), more showed a differential response to tiotropium for FEV1 (n = 104) than salmeterol (n = 62). An acute response to a short-acting bronchodilator, especially albuterol, predicted a positive clinical response to tiotropium for FEV1 (odds ratio, 4.08; 95% CI, 2.00-8.31; P < .001) and morning PEF (odds ratio, 2.12; 95% CI, 1.12-4.01; P = 0.021), as did a decreased FEV1/forced vital capacity ratio (FEV1 response increased 0.39% of baseline for every 1% decrease in FEV1/forced vital capacity ratio). Higher cholinergic tone was also a predictor, whereas ethnicity, sex, atopy, IgE level, sputum eosinophil count, fraction of exhaled nitric oxide, asthma duration, and body mass index were not. CONCLUSION: Although these results require confirmation, predictors of a positive clinical response to tiotropium include a positive response to albuterol and airway obstruction, factors that could help identify appropriate patients for this therapy.
Keywords	adults ; asthma ; atopy ; blood ; body mass index ; bronchodilators ; heart ; immunoglobulin E ; nationalities and ethnic groups ; nitric oxide ; odds ratio ; patients ; therapeutics
Language	English
Dates of publication	2013-11
Size	p. 1068-1074.e1.
Publishing place	Mosby, Inc.
Document type	Article
ZDB-ID	121011-7
ISSN	1085-8725 ; 1097-6825 ; 0091-6749
ISSN (online)	1085-8725 ; 1097-6825
ISSN	0091-6749
DOI	10.1016/j.jaci.2013.08.003
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Article ; Online: Effect of vitamin D3 on asthma treatment failures in adults with symptomatic asthma and lower vitamin D levels: the VIDA randomized clinical trial.

Castro, Mario / King, Tonya S / Kunselman, Susan J / Cabana, Michael D / Denlinger, Loren / Holguin, Fernando / Kazani, Shamsah D / Moore, Wendy C / Moy, James / Sorkness, Christine A / Avila, Pedro / Bacharier, Leonard B / Bleecker, Eugene / Boushey, Homer A / Chmiel, James / Fitzpatrick, Anne M / Gentile, Deborah / Hundal, Mandeep / Israel, Elliot /

JAMA

2014 Volume 311, Issue 20, Page(s) 2083–2091

Abstract: Importance: In asthma and other diseases, vitamin D insufficiency is associated with adverse outcomes. It is not known if supplementing inhaled corticosteroids with oral vitamin D3 improves outcomes in patients with asthma and vitamin D insufficiency.!## ...

Abstract	Importance: In asthma and other diseases, vitamin D insufficiency is associated with adverse outcomes. It is not known if supplementing inhaled corticosteroids with oral vitamin D3 improves outcomes in patients with asthma and vitamin D insufficiency. Objective: To evaluate if vitamin D supplementation would improve the clinical efficacy of inhaled corticosteroids in patients with symptomatic asthma and lower vitamin D levels. Design, setting, and participants: The VIDA (Vitamin D Add-on Therapy Enhances Corticosteroid Responsiveness in Asthma) randomized, double-blind, parallel, placebo-controlled trial studying adult patients with symptomatic asthma and a serum 25-hydroxyvitamin D level of less than 30 ng/mL was conducted across 9 academic US medical centers in the National Heart, Lung, and Blood Institute's AsthmaNet network, with enrollment starting in April 2011 and follow-up complete by January 2014. After a run-in period that included treatment with an inhaled corticosteroid, 408 patients were randomized. Interventions: Oral vitamin D3 (100,000 IU once, then 4000 IU/d for 28 weeks; n = 201) or placebo (n = 207) was added to inhaled ciclesonide (320 µg/d). If asthma control was achieved after 12 weeks, ciclesonide was tapered to 160 µg/d for 8 weeks, then to 80 µg/d for 8 weeks if asthma control was maintained. Main outcomes and measures: The primary outcome was time to first asthma treatment failure (a composite outcome of decline in lung function and increases in use of β-agonists, systemic corticosteroids, and health care). Results: Treatment with vitamin D3 did not alter the rate of first treatment failure during 28 weeks (28% [95% CI, 21%-34%] with vitamin D3 vs 29% [95% CI, 23%-35%] with placebo; adjusted hazard ratio, 0.9 [95% CI, 0.6-1.3]). Of 14 prespecified secondary outcomes, 9 were analyzed, including asthma exacerbation; of those 9, the only statistically significant outcome was a small difference in the overall dose of ciclesonide required to maintain asthma control (111.3 µg/d [95% CI, 102.2-120.4 µg/d] in the vitamin D3 group vs 126.2 µg/d [95% CI, 117.2-135.3 µg/d] in the placebo group; difference of 14.9 µg/d [95% CI, 2.1-27.7 µg/d]). Conclusions and relevance: Vitamin D3 did not reduce the rate of first treatment failure or exacerbation in adults with persistent asthma and vitamin D insufficiency. These findings do not support a strategy of therapeutic vitamin D3 supplementation in patients with symptomatic asthma. Trial registration: clinicaltrials.gov Identifier: NCT01248065.
MeSH term(s)	Administration, Inhalation ; Administration, Oral ; Adrenal Cortex Hormones/administration & dosage ; Adult ; Anti-Asthmatic Agents/administration & dosage ; Asthma/complications ; Asthma/drug therapy ; Asthma/physiopathology ; Cholecalciferol/therapeutic use ; Dose-Response Relationship, Drug ; Double-Blind Method ; Female ; Glucocorticoids/administration & dosage ; Humans ; Lung/drug effects ; Lung/physiopathology ; Male ; Middle Aged ; Pregnenediones/administration & dosage ; Treatment Failure ; Vitamin D Deficiency/complications ; Vitamin D Deficiency/drug therapy ; Vitamins/therapeutic use
Chemical Substances	Adrenal Cortex Hormones ; Anti-Asthmatic Agents ; Glucocorticoids ; Pregnenediones ; Vitamins ; Cholecalciferol (1C6V77QF41) ; ciclesonide (S59502J185)
Language	English
Publishing date	2014-05-17
Publishing country	United States
Document type	Journal Article ; Multicenter Study ; Randomized Controlled Trial ; Research Support, N.I.H., Extramural
ZDB-ID	2958-0
ISSN	1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
ISSN (online)	1538-3598
ISSN	0254-9077 ; 0002-9955 ; 0098-7484
DOI	10.1001/jama.2014.5052
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