Body Mass Index Change In Gastrointestinal Cancer And Chronic Obstructive Pulmonary Disease Is Associated With Dedicator Of Cytokinesis 1,
2017
Harvard Medical School
Body Mass Index Change In Gastrointestinal Cancer And Chronic Obstructive Pulmonary Disease Is Associated With Dedicator Of Cytokinesis 1, Merry-Lynn Noelle Mcdonald, Sungho Won, Manuel Mattheisen, Peter J. Castaldi, Michael H. Cho, Erica Rutten, Megan Hardin, Wai-Ki Yip, Stephen I. Rennard, David A. Lomas, Emiel F.M. Wouters, Alvar Agusti, Richard Casaburi, Christoph P. Lange, George O'Connor, Craig P. Hersh, Edwin K. Silverman
Journal Articles: Pulmonary & Critical Care Med
BACKGROUND: There have been a number of candidate gene association studies of cancer cachexia-related traits, but no genome-wide association study (GWAS) has been published to date. Cachexia presents in patients with a number of complex traits, including both cancer and COPD. The objective of the current investigation was to search for a shared genetic aetiology for change in body mass index (ΔBMI) among cancer and COPD by using GWAS data in the Framingham Heart Study.
METHODS: A linear mixed effects model accounting for age, sex, and change in smoking status was used to calculate ΔBMI in participants over 40 years …
A Case Of Difficult-To-Treat Asthma Due To Uncontrolled Atypical Gastroesophageal Reflux,
2017
Western Michigan University Homer Stryker MD School of Medicine
A Case Of Difficult-To-Treat Asthma Due To Uncontrolled Atypical Gastroesophageal Reflux, Alissa Welsh, Andrey Leonov
Research Day
Introduction: In uncontrolled asthma, comorbid conditions should be treated in order to achieve better asthma control. The contribution of gastro-esophageal reflux (GER) may be overlooked when its presentation is atypical. Case Report: 11 year-old male with moderate persistent asthma and allergic rhinitis presented with persistent barky cough, diagnosed as spasmodic croup after bronchoscopy, esophagram, swallow study and magnified airway x-ray failed to show anatomical abnormality. Empiric proton pump inhibitor (PPI) treatment was started with improvement in cough. Patient was referred to Gastroenterology for evaluation of GER, despite lack of heartburn or vomiting. Endoscopy revealed esophageal candida infection which was treated. …
Network-Based Analysis Reveals Novel Gene Signatures In Peripheral Blood Of Patients With Chronic Obstructive Pulmonary Disease,
2017
St Paul's Hospital
Network-Based Analysis Reveals Novel Gene Signatures In Peripheral Blood Of Patients With Chronic Obstructive Pulmonary Disease, Ma'en Obeidat, Yunlong Nie, Virginia Chen, Casey P. Shannon, Anand Kumar Andiappan, Bernett Lee, Olaf Rotzschke, Peter J. Castaldi, Craig P. Hersh, Nick Fishbane, Raymond T. Ng, Bruce Mcmanus, Bruce E. Miller, Stephen I. Rennard, Peter D. Paré, Don D. Sin
Journal Articles: Pulmonary & Critical Care Med
BACKGROUND: Chronic obstructive pulmonary disease (COPD) is currently the third leading cause of death and there is a huge unmet clinical need to identify disease biomarkers in peripheral blood. Compared to gene level differential expression approaches to identify gene signatures, network analyses provide a biologically intuitive approach which leverages the co-expression patterns in the transcriptome to identify modules of co-expressed genes.
METHODS: A weighted gene co-expression network analysis (WGCNA) was applied to peripheral blood transcriptome from 238 COPD subjects to discover co-expressed gene modules. We then determined the relationship between these modules and forced expiratory volume in 1 s (FEV …
Tissue Factor Expression, Regulation, And Signaling In Human Airway Cells,
2017
Virginia Commonwealth University
Tissue Factor Expression, Regulation, And Signaling In Human Airway Cells, Michael D. Davis
Theses and Dissertations
Rationale: Tissue Factor (TF) is a transmembrane glycoprotein that canonically functions as the initiator of the coagulation cascade. Increased levels of TF have been associated with inflammatory airway diseases. Since lipopolysaccharide (LPS) is known to elicit and inflammatory response in airway epithelium, we hypothesized that airway epithelial cells release TF when exposed to LPS. Since TF aids in local wound healing, we also hypothesized that inhibition of TF would decrease NHBE growth. The specific aim of this work was to evaluate the effects of LPS exposure on TF production and release from airway epithelia and determine the signaling pathways involved. …
A Behavioral And Neuroimmune System Model Of The Effects Of Chronic Low-Level Lead Exposure In Young Male C57bl/6j Mice,
2017
University of Texas at El Paso
A Behavioral And Neuroimmune System Model Of The Effects Of Chronic Low-Level Lead Exposure In Young Male C57bl/6j Mice, Mayra Gisel Flores-Montoya
Open Access Theses & Dissertations
Chronic low-level lead exposure reduces memory in children however the brain mechanisms mediating these effects are not known. In previous studies we showed that early lead exposure reduced olfactory memory and exploratory behavior in young mice, and reduced microglia cell density in hippocampus/dentate gyrus. The present studies aimed to identify additional behavioral tests that were sensitive to early low-level lead exposure in young mice; and to examine whether microglia upregulated factors known to promote cell migration. Seventy-two C57BL/6J male mice were exposed to 0 ppm (controls), 30 ppm (low-dose), or 430 ppm (high-dose) of lead acetate via dams' milk from …
Comparison Of Allergens Collected From Furnace Filters And Vacuum Floor Dust.,
2017
Children's Mercy Hospital
Comparison Of Allergens Collected From Furnace Filters And Vacuum Floor Dust., Ryan Allenbrand, Charles S. Barnes, Mubeen Mohammed, Luke Gard, Freddy Pacheco, Kevin Kennedy, Anita Didonna, Jay M. Portnoy, Chitra Dinakar
Manuscripts, Articles, Book Chapters and Other Papers
No abstract provided.
Introduction Of Peanuts To The Pediatric Patient,
2017
University of North Dakota
Introduction Of Peanuts To The Pediatric Patient, Leslee Graff
Physician Assistant Scholarly Project Posters
Peanut allergies have been diagnosed exponentially over the last ten-years and are more severe now than ever before. (DuToit et al. 2106) Some of the latest statistics are citing more than double the amount of peanut allergies diagnosed in the last few years. Guidelines set forth in 2010, by the American Academy of Allergy, Asthma, and Immunology stated that peanut, milk, soy, wheat, egg, and other tree nuts were to be avoided until three years of age, unless these patients have other chronic illnesses such as asthma or other atopic conditions. If so, the patient is to abstain from these …
International Consensus (Icon) On: Clinical Consequences Of Mite Hypersensitivity, A Global Problem.,
2017
Children's Mercy Hospital
International Consensus (Icon) On: Clinical Consequences Of Mite Hypersensitivity, A Global Problem., Mario Sánchez-Borges, Enrique Fernandez-Caldas, Wayne R. Thomas, Martin D. Chapman, Bee Wah Lee, Luis Caraballo, Nathalie Acevedo, Fook Tim Chew, Ignacio J. Ansotegui, Leili Behrooz, Wanda Phipatanakul, Roy Gerth Van Wijk, Demoly Pascal, Nelson Rosario, Motohiro Ebisawa, Mario Geller, Santiago Quirce, Susanne Vrtala, Rudolf Valenta, Markus Ollert, Giorgio Walter Canonica, Moises A. Calderón, Charles S. Barnes, Adnan Custovic, Suwat Benjaponpitak, Arnaldo Capriles-Hulett
Manuscripts, Articles, Book Chapters and Other Papers
Since mite allergens are the most relevant inducers of allergic diseases worldwide, resulting in significant morbidity and increased burden on health services, the International Collaboration in Asthma, Allergy and Immunology (iCAALL), formed by the American Academy of Allergy, Asthma and Immunology (AAAAI), the American College of Allergy, Asthma and Immunology (ACAAI), the European Academy of Allergy and Clinical Immunology (EAACI), and the World Allergy Organization (WAO), has proposed to issue an International Consensus (ICON) on the clinical consequences of mite hypersensitivity. The objectives of this document are to highlight aspects of mite biology that are clinically relevant, to update the …
Type 2 Immune Responses In The Context Of Helminth Infection, Asthma, Dendritic Cells, And Myeloid Derived Suppressor Cell Function,
2017
Virginia Commonwealth University
Type 2 Immune Responses In The Context Of Helminth Infection, Asthma, Dendritic Cells, And Myeloid Derived Suppressor Cell Function, Sheela Ruby Damle
Theses and Dissertations
Type 2 (TH2) immune responses evolved to respond to helminth parasite infections by the production of TH2 cytokines, which stimulate anti-helminth immunity. Macrophage migration inhibitor factor (MIF) is a pleiotropic cytokine, which is produced by many cell types. We demonstrate that mice deficient in MIF have enhanced clearance of a helminth parasite. MIF deficiency in CD4+ T cells was found to be the most important for mediating parasite clearance. We mimicked MIF deficiency by administering an inhibitor of the MIF tautomerase activity, sulforaphane, and this also increased parasite clearance (Section I).
TH2 immune …
Peanut Allergen Threshold Study (Pats): Novel Single-Dose Oral Food Challenge Study To Validate Eliciting Doses In Children With Peanut Allergy,
2017
University College, Cork
Peanut Allergen Threshold Study (Pats): Novel Single-Dose Oral Food Challenge Study To Validate Eliciting Doses In Children With Peanut Allergy, Jonathan O'B. Hourihane, Katrina J. Allen, Wayne G. Shreffler, Gillian Dunngalvin, Julie A. Nordlee, Giovanni A. Zurzolo, Audrey Dunngalvin, Lyle C. Gurrin, Joseph L. Baumert, Steve L. Taylor
Department of Food Science and Technology: Faculty Publications
Background: Eliciting doses (EDs) of allergenic foods can be defined by the distribution of threshold doses for subjects within a specific population. The ED05 is the dose that elicits a reaction in 5% of allergic subjects. The predicted ED05 for peanut is 1.5 mg of peanut protein (6 mg of whole peanut).
Objective: We sought to validate the predicted peanut ED05 (1.5 mg) with a novel single-dose challenge.
Methods: Consecutive eligible children with peanut allergy in 3 centers were prospectively invited to participate, irrespective of previous reaction severity. Predetermined criteria for objective reactions were used …
Monitoring Pollen Counts And Pollen Allergy Index Using Satellite Observations In East Coast Of The United States,
2017
South Dakota State University
Monitoring Pollen Counts And Pollen Allergy Index Using Satellite Observations In East Coast Of The United States, Murat Cagatay Kececi
Electronic Theses and Dissertations
Allergic diseases have become increasingly common over the world during the last four decades, and they are affecting millions of people. Pollination is an important process in the life cycle of plants. However, pollen exposure is associated with allergic diseases such as asthma and seasonal allergic rhinitis (hay fever). As a result, the total annual expenditure for asthma-associated morbidity is about $56 billion in the United States, and the overall cost of allergic diseases is over $18 billion annually. For allergic rhinitis, the annual medical cost is approximately $3.4 billion. The intensity and frequency of the pollen exposures can be …
Erratum To: Scaling Up Strategies Of The Chronic Respiratory Disease Programme Of The European Innovation Partnership On Active And Healthy Ageing (Action Plan B3: Area 5).,
2017
Children's Mercy Hospital
Erratum To: Scaling Up Strategies Of The Chronic Respiratory Disease Programme Of The European Innovation Partnership On Active And Healthy Ageing (Action Plan B3: Area 5)., J Bousquet, J Farrell, G Crooks, P Hellings, E H. Bel, M Bewick, N H. Chavannes, J Correia De Sousa, A A. Cruz, T Haahtela, G Joos, N Khaltaev, J Malva, A Muraro, M Nogues, S Palkonen, S Pedersen, C Robalo-Cordeiro, B Samolinski, T Strandberg, A Valiulis, A Yorgancioglu, T Zuberbier, A Bedbrook, W Aberer, M Adachi, A Agusti, C A Akdis, M Akdis, J Ankri, A Alonso, I Annesi-Maesano, I J. Ansotegui, J M. Anto, S Arnavielhe, H Arshad, C Bai, I Baiardini, C Bachert, A K. Baigenzhin, C Barbara, E D. Bateman, B Beghé, A Ben Kheder, K S. Bennoor, M Benson, K C. Bergmann, T Bieber, C Bindslev-Jensen, L Bjermer, H Blain, F Blasi, A L. Boner, M Bonini, S Bonini, S Bosnic-Anticevitch, L P. Boulet, R Bourret, P J. Bousquet, F Braido, A H. Briggs, C E. Brightling, J Brozek, R Buhl, P G. Burney, A Bush, F Caballero-Fonseca, D Caimmi, M A. Calderon, P M. Calverley, P A M Camargos, G W. Canonica, T Camuzat, K H. Carlsen, W Carr, A Carriazo, T Casale, A M. Cepeda Sarabia, L Chatzi, Y Z. Chen, R Chiron, E Chkhartishvili, A G. Chuchalin, K F. Chung, G Ciprandi, I Cirule, L Cox, D J. Costa, A Custovic, R Dahl, S E. Dahlen, U Darsow, G De Carlo, F De Blay, T Dedeu, D Deleanu, E De Manuel Keenoy, P Demoly, J A. Denburg, P Devillier, A Didier, A T. Dinh-Xuan, R Djukanovic, D Dokic, H Douagui, G Dray, R Dubakiene, S R. Durham, M S. Dykewicz, Y El-Gamal, R Emuzyte, L M. Fabbri, M Fletcher, A Fiocchi, A Fink Wagner, J Fonseca, W J. Fokkens, F Forastiere, P Frith, M Gaga, A Gamkrelidze, J Garces, J Garcia-Aymerich, B Gemicioğlu, J E. Gereda, S González Diaz, M Gotua, I Grisle, L Grouse, Z Gutter, M A. Guzmán, L G. Heaney, B Hellquist-Dahl, D Henderson, A Hendry, J Heinrich, D Heve, F Horak, J O' B Hourihane, P Howarth, M Humbert, M E. Hyland, M Illario, J C. Ivancevich, J R. Jardim, E J. Jares, C Jeandel, C Jenkins, S L. Johnston, O Jonquet, K Julge, K S. Jung, J Just, I Kaidashev, M R. Khaitov, O Kalayci, A F. Kalyoncu, T Keil, P K. Keith, L Klimek, B Koffi N'Goran, V Kolek, G H. Koppelman, M L. Kowalski, I Kull, P Kuna, V Kvedariene, B Lambrecht, S Lau, D Larenas-Linnemann, D Laune, L T T Le, P Lieberman, B Lipworth, J Li, K Lodrup Carlsen, R Louis, W Macnee, Y Magard, A Magnan, B Mahboub, A Mair, I Majer, M J. Makela, P Manning, S Mara, G D. Marshall, M R. Masjedi, P Matignon, M Maurer, S Mavale-Manuel, E Melén, E Melo-Gomes, E O. Meltzer, A Menzies-Gow, H Merk, J P. Michel, N Miculinic, F Mihaltan, B Milenkovic, G M Y Mohammad, M Molimard, I Momas, A Montilla-Santana, M Morais-Almeida, M Morgan, R Mösges, J Mullol, S Nafti, L Namazova-Baranova, R Naclerio, A Neou, H Neffen, K Nekam, B Niggemann, G Ninot, T D. Nyembue, R E. O'Hehir, K Ohta, Y Okamoto, K Okubo, S Ouedraogo, P Paggiaro, I Pali-Schöll, P Panzner, N Papadopoulos, A Papi, H S. Park, G Passalacqua, I Pavord, R Pawankar, R Pengelly, O Pfaar, R Picard, B Pigearias, I Pin, D Plavec, D Poethig, W Pohl, T A. Popov, F Portejoie, P Potter, D Postma, D Price, K F. Rabe, F Raciborski, F Radier Pontal, S Repka-Ramirez, S Reitamo, S Rennard, F Rodenas, J Roberts, J Roca, L Rodriguez Mañas, C Rolland, M Roman Rodriguez, A Romano, J Rosado-Pinto, N Rosario, L Rosenwasser, M Rottem, D Ryan, M Sanchez-Borges, G K. Scadding, H J. Schunemann, E Serrano, P Schmid-Grendelmeier, H Schulz, A Sheikh, M Shields, N Siafakas, Y Sibille, T Similowski, F E R Simons, J C. Sisul, I Skrindo, H A. Smit, D Solé, T Sooronbaev, O Spranger, R Stelmach, P J. Sterk, J Sunyer, C Thijs, T To, A Todo-Bom, M Triggiani, R Valenta, A L. Valero, E Valia, E Valovirta, E Van Ganse, M Van Hage, O Vandenplas, T Vasankari, B Vellas, J Vestbo, G Vezzani, P Vichyanond, G Viegi, C Vogelmeier, T Vontetsianos, M Wagenmann, B Wallaert, S Walker, D Y. Wang, U Wahn, M Wickman, D M. Williams, S Williams, J Wright, B P. Yawn, P K. Yiallouros, O M. Yusuf, A Zaidi, H J. Zar, M E. Zernotti, L Zhang, N Zhong, M Zidarn, J Mercier
Manuscripts, Articles, Book Chapters and Other Papers
[This corrects the article DOI: 10.1186/s13601-016-0116-9.].
Ehd1 As A Positive Regulator Of Macrophage Colony-Stimulating Factor-1 Receptor,
2016
University of Nebraska Medical Center
Ehd1 As A Positive Regulator Of Macrophage Colony-Stimulating Factor-1 Receptor, Luke R. Cypher
Theses & Dissertations
The master regulator of the macrophage development, differentiation, proliferation, survival, phagocytosis, cytokine secretion, motility, adhesion, migration, and spreading is the receptor tyrosine kinase (RTK) colony stimulating factor-1 receptor (CSF-1R). Aberrant CSF-1R signaling is present amongst a variety of highly prevalent and devastating human diseases in the United States such as atherosclerosis, cancer, inflammatory bowel disease, arthritis, and neuro-demyelination/neuro-degeneration. A better understanding of basic mechanisms that govern macrophage development and function is of vital importance in treating patients afflicted with these conditions/diseases. CSF-1R presentation on the macrophage cell surface is a required precursor for CSF1- induced RTK dimerization (activation) and downstream …
Sa-4-1bbl As A Modulator Of Innate, Adaptive, And Regulatory Immunity : Implications For Cancer Prevention And Treatment.,
2016
University of Louisville
Sa-4-1bbl As A Modulator Of Innate, Adaptive, And Regulatory Immunity : Implications For Cancer Prevention And Treatment., Hampartsoum Barsoumian
Electronic Theses and Dissertations
SA-4-1BBL is a recombinant costimulatory molecule that is active in its soluble form and has pleiotropic effects on the functions of innate, adaptive, and regulatory immune cells. We have previously shown that SA-4-1BBL makes CD4+ T conventional cells (Tconvs) resistant to suppression by CD4+CD25+Foxp3+ T regulatory cells (Tregs). The mechanistic basis of this observation is the subject of this study. We demonstrate that Tconvs, but not Tregs, are the direct targets of SA-4-1BBL-mediated evasion of Treg suppression without contribution from antigen presenting cells (APCs). SA-4-1BBL engagement with its receptor, 4-1BB, on Tconvs resulted in the production of high levels of …
Case Report: Recurrent Staphylococcal Scalded Skin Syndrome In Healthy Term Neonate Despite Full Course Of Antibiotic Therapy,
2016
Marshall University School of Medicine
Case Report: Recurrent Staphylococcal Scalded Skin Syndrome In Healthy Term Neonate Despite Full Course Of Antibiotic Therapy, Indira Bhavsar, Rebecca Hayes, Amy Vaughan
Marshall Journal of Medicine
Background
Staphylococcal scalded skin syndrome (SSSS) describes a blistering skin infection caused by the exfoliative toxin in the bacterium Staphylococcus aureus. It more commonly affects the infant population and is characterized by large blistering bullae that rupture upon application of pressure.
Case description
We describe a case of recurrent SSSS in a healthy term neonate who initially presented with a perioral rash on day of life (DOL) 11 that quickly became vesicular with new lesions on the sternum and extremities. The patient’s rash began to resolve upon administration of culture-specific IV antibiotics. She was appropriately treated with a 14-day …
The Effects Of Allergies And Anaphylaxis On The Body And Mind: A Survey Of Opinions And Knowledge On These Disorders,
2016
Augustana College, Rock Island Illinois
The Effects Of Allergies And Anaphylaxis On The Body And Mind: A Survey Of Opinions And Knowledge On These Disorders, Kathryn E. O'Brien
Honors Program: Student Scholarship & Creative Works
Despite common knowledge, allergies and anaphylaxis are considered disabilities. As such, these disorders affect the daily lives of those who have them, including one's mental health. In this paper, all the nuances of allergies and anaphylaxis will be discussed as the etiology and scientific aspects of allergies, anaphylaxis, and hypersensitivity are distinguished from one another. Furthermore, the findings are reported from two surveys; an assessment of how well educated and prepared teachers are for students with allergies and whether other students with food allergies have had similar experiences to the author's and those described in research by other studies concerning …
Sublingual Immunotherapy: Is It A Viable Option To Subcutaneous Immunotherapy When Treating Allergic Rhinitis?,
2016
University of North Dakota
Sublingual Immunotherapy: Is It A Viable Option To Subcutaneous Immunotherapy When Treating Allergic Rhinitis?, David Ryan Kesterson
Physician Assistant Scholarly Project Posters
• Background: Allergic rhinitis (AR) is a very common debilitating disease that can be detrimental to one’s lifestyle, work, and home life. Immunotherapy is the only treatment option that has disease modifying capabilities with a proper therapeutic regimen. Subcutaneous immunotherapy (SCIT) was developed over 100 years ago and has been the gold standard in immunotherapy for many years in the United States. During these years many adverse reactions have been reported with SCIT along with non-adherence to total treatment. The introduction of sublingual immunotherapy (SLIT) over 20 years ago gave providers a promising alternative to SCIT.
• Method: A review …
Interpreting Patient-Reported Outcomes From Clinical Trials In Copd: A Discussion,
2016
University of London
Interpreting Patient-Reported Outcomes From Clinical Trials In Copd: A Discussion, Paul W. Jones, Stephen I. Rennard, Maggie Tabberer, John H. Riley, Mitra Vahdati-Bolouri, Neil C. Barnes
Journal Articles: Pulmonary & Critical Care Med
One of the challenges faced by the practising physician is the interpretation of patient-reported outcomes (PROs) in clinical trials and the relevance of such data to their patients. This is especially true when caring for patients with progressive diseases such as COPD. In an attempt to incorporate the patient perspective, many clinical trials now include assessments of PROs. These are formalized methods of capturing patient-centered information. Given the importance of PROs in evaluating the potential utility of an intervention for a patient with COPD, it is important that physicians are able to critically interpret (and critique) the results derived from …
Upregulation Of Rgs2: A New Mechanism For Pirfenidone Amelioration Of Pulmonary Fibrosis,
2016
Creighton University School of Medicine
Upregulation Of Rgs2: A New Mechanism For Pirfenidone Amelioration Of Pulmonary Fibrosis, Yan Xie, Haihong Jiang, Qian Zhang, Suneet Mehrotra, Peter W. Abel, Myron L. Toews, Dennis W. Wolff, Stephen I. Rennard, Reynold A. Panettieri, Thomas B. Casale, Yaping Tu
Journal Articles: Pulmonary & Critical Care Med
BACKGROUND: Pirfenidone was recently approved for treatment of idiopathic pulmonary fibrosis. However, the therapeutic dose of pirfenidone is very high, causing side effects that limit its doses and therapeutic effectiveness. Understanding the molecular mechanisms of action of pirfenidone could improve its safety and efficacy. Because activated fibroblasts are critical effector cells associated with the progression of fibrosis, this study investigated the genes that change expression rapidly in response to pirfenidone treatment of pulmonary fibroblasts and explored their contributions to the anti-fibrotic effects of pirfenidone.
METHODS: We used the GeneChip microarray to screen for genes that were rapidly up-regulated upon exposure …
Effects Of Roflumilast In Copd Patients Receiving Inhaled Corticosteroid/Long-Acting Β2-Agonist Fixed-Dose Combination: Re(2)Spond Rationale And Study Design,
2016
University of Nebraska Medical Center
Effects Of Roflumilast In Copd Patients Receiving Inhaled Corticosteroid/Long-Acting Β2-Agonist Fixed-Dose Combination: Re(2)Spond Rationale And Study Design, Stephen I. Rennard, Fernando J. Martinez, Klaus F. Rabe, Sanjay Sethi, Emilio Pizzichini, Andrew Mcivor, Shahid Siddiqui, Antonio Anzueto, Haiyuan Zhu
Journal Articles: Pulmonary & Critical Care Med
BACKGROUND: Roflumilast, a once-daily, selective phosphodiesterase-4 inhibitor, reduces the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. The RE(2)SPOND study is examining whether roflumilast, when added to an inhaled corticosteroid/long-acting β2-agonist (ICS/LABA) fixed-dose combination (FDC), further reduces exacerbations. The methodology is described herein.
METHODS: In this Phase IV, multicenter, double-blind, placebo-controlled, parallel-group trial, participants were randomized 1:1 (stratified by long-acting muscarinic antagonist use) to receive roflumilast or placebo, plus ICS/LABA FDC, for 52 weeks. Eligible participants had severe COPD associated with chronic bronchitis, had two or more moderate-severe exacerbations within …
