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5. Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Ahlström Emanuelsson, Cecilia, Ardusso, Ledit, Armstrong, Michael, Bardin, Philip, Barnes, Sara, Bergna, Miguel, Betz, Christian, Beule, Achim, Blotter, James, Bronescu, Valeriu, Brown, Matthew, Carrie, Sean, Chaker, Adam, Cho, Hyung-Ju, Corriveau, Marie-Noëlle, Courville, Timothy, Cuevas, Mandy, Damask, Cecelia, DeConde, Adam, Del Carpio, Jaime, De Salvo, María, Dhong, Hun-Jong, Durham, Stephen, Edin, Anton, Ehmer Jr, Dale, Elías, Pedro, Fatakia, Adil, Franzese, Christine, Gane, Simon, García, Gabriel, Gillman, Andrew, Groeger, Moritz, Harvey, Richard, Hellgren, Johan, Higgins, Thomas, Hobson, Jonathan, Jangard, Mattias, Janjua, Arif, Kara, Naveed, Karpischenko, Sergey, Kerwin, Edward, Khanova, Fatimat, Kilty, Shaun, Kim, Chang-Hoon, Kim, Seontae, Klimek, Ludger, LaForce, Craig, Leong, Samuel, Marple, Bradley, Mårtensson, Anders, Maspero, Jorge, Massey, Neil, Matz, Jonathan, McDuffie, Chad, Mella, Corina, Miller, Steven, Mirzabekyan, Ekaterina, Moss, Jonathan, Mumneh, Nayla, Nathan, Robert, Neagos, Adriana, Olze, Heidi, Ovchinnikov, Andrey, Ow, Randall, Polyakov, Dmitriy, Radeanu, Doinel, Rhee, Chae-Seo, Rojas, Ramón, Rosenbloom, Jeffrey, Ryazantsev, Sergei, Sader, Chady, Saez Scherbovsky, Pablo, Scadding, Guy, Schlosser, Rodney, Shah-Patel, Heena, Shealy, Ronald, Siddiqi, Ayesha, Silvers, Stacey, Singh, Narinder, Sommer, Doron, Soong, Weily, Sowerby, Leigh, Spafford, Peter, Stefan, Catalin, Sterling, Richard, Svistushkin, Valeriy, Talreja, Neetu, Tarasova, Galina, Tarpay, Martha, Tolcachier, Alberto, Toll, Karin Toll, van Schaik, Carolina, Webb, Luke, Wedner, H James, Wehbe, Luis, Whan Kim, Soo, Wollenberg, Barbara, Wright, Simon, Yakusevich, Vladimir, Yañez, Anahí, Yarin, Yury, Yen, David, Yeol Kim, Hyo, Han, Joseph K, Bachert, Claus, Fokkens, Wytske, Desrosiers, Martin, Wagenmann, Martin, Lee, Stella E, Smith, Steven G, Martin, Neil, Mayer, Bhabita, Yancey, Steven W, Sousa, Ana R, Chan, Robert, and Hopkins, Claire

Published
2021
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7. Evaluating treatment response to mepolizumab in patients with severe CRSwNP*

Author

Hopkins, Claire, Han, Joseph K., Lund, Valerie J., Bachert, Claus, Fokkens, Wytske J., Diamant, Zuzana, Mullol, Joaquim, Sousa, Ana R., Smith, Steven G., Yang, Shibing, Mayer, Bhabita, Yancey, Steve W., Chan, Robert H., and Lee, Stella E.

Subjects
nasal polyps, biological products, mepolizumab, systemic corticosteroid use, disease-specific quality of life
Abstract

Background: The SYNAPSE study (NCT03085797) demonstrated that mepolizumab decreased nasal polyp (NP) size and nasal obstruction in patients with chronic rhinosinusitis with NP (CRSwNP). Methods: SYNAPSE, a randomized, double-blind study, included patients with recurrent, refractory, severe CRSwNP, eligible for repeated surgery despite receiving standard of care (SoC). Patients received 4-weekly mepolizumab 100 mg or placebo subcutaneously plus SoC for 52 weeks. This post hoc analysis further characterized treatment responses and association with patient characteristics. The proportion of patients meeting any and each of five response criteria indicating improvement in disease-specific quality of life, NP size, nasal obstruction, loss of smell, and overall symptoms at Weeks 24 and 52, were assessed in subgroups: 1) no surgery; 2) neither surgery nor systemic corticosteroids (SCS). Results: Of 407 patients in the intention-to-treat population, 381 and 343 patients had no sinus surgery by Weeks 24 and 52, respectively. More mepolizumab- versus placebo-treated patients without surgery by Weeks 24 and 52 met each response criteria. Of the mepolizumab-treated patients without surgery by Week 24, 109 (55%) responded across ≥ 3 criteria, increasing to 126 (67%) by Week 52. Similar response trends were seen for patients with neither surgery nor SCS by Weeks 24 and 52. At either timepoint, there were no major differences in baseline characteristics between mepolizumab-treated full- (5/5 categories) and non-responders (0/5 categories). Conclusions: Most patients who completed SYNAPSE required neither surgery nor SCS use and in addition achieved a progressive and sustained clinical response to mepolizumab underscoring the therapeutic benefits of mepolizumab in severe CRSwNP.

Published
2023

10. Additional file 1 of Mepolizumab improvements in health-related quality of life and disease symptoms in a patient population with very severe chronic rhinosinusitis with nasal polyps: psychometric and efficacy analyses from the SYNAPSE study

Author

Fokkens, Wytske, Trigg, Andrew, Lee, Stella E., Chan, Robert H., Diamant, Zuzana, Hopkins, Claire, Howarth, Peter, Lund, Valerie, Mayer, Bhabita, Sousa, Ana R., Yancey, Steve, and Tabberer, Maggie

Abstract

Additional file 1. Supplementary methods and results.

Published
2023
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11. Mepolizumab for chronic rhinosinusitis with nasal polyps ( SYNAPSE ): In‐depth sinus surgery analysis

Author

Fokkens, Wytske J., primary, Mullol, Joaquim, additional, Kennedy, David, additional, Philpott, Carl, additional, Seccia, Veronica, additional, Kern, Robert C., additional, Coste, André, additional, Sousa, Ana R., additional, Howarth, Peter H., additional, Benson, Victoria S., additional, Mayer, Bhabita, additional, Yancey, Steve W., additional, Chan, Robert, additional, and Gane, Simon B., additional

Published
2022
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13. Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): In‐depth sinus surgery analysis.

Author

Fokkens, Wytske J., Mullol, Joaquim, Kennedy, David, Philpott, Carl, Seccia, Veronica, Kern, Robert C., Coste, André, Sousa, Ana R., Howarth, Peter H., Benson, Victoria S., Mayer, Bhabita, Yancey, Steve W., Chan, Robert, and Gane, Simon B.

Subjects
ENDOSCOPIC surgery, NASAL polyps, CLINICAL trials, SINUSITIS, SYNAPSES, REOPERATION
Abstract

Background: Patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) often require repeat sinus surgery. Mepolizumab reduced the need for sinus surgery in the SYNAPSE trial; this analysis sought to provide a more in‐depth assessment of surgery endpoints in SYNAPSE. Methods: SYNAPSE was a double‐blind Phase III trial (NCT03085797) in adults with recurrent, refractory, severe, CRSwNP eligible for repeat sinus surgery despite standard of care treatments and previous surgery. Patients were randomized (1:1) to mepolizumab 100 mg subcutaneously or placebo, plus standard of care, every 4 weeks for 52 weeks. Time to first inclusion on a waiting list for sinus surgery and time to first actual sinus surgery (both up to week 52) were assessed; the latter endpoint was also analyzed post hoc according to time since last sinus surgery before study screening and baseline blood eosinophil count. Results: Among 407 patients (mepolizumab: 206; placebo: 201), mepolizumab versus placebo reduced the risk of being included on a waiting list for sinus surgery (week 52 Kaplan–Meier probability estimate [95% confidence interval]: 13.9% [9.8%, 19.5%] vs. 28.5% [22.7%, 35.4%]). Mepolizumab versus placebo reduced the risk of sinus surgery irrespective of time (<3 vs ≥3 years) since patients' last sinus surgery prior to study screening (hazard ratios [95% confidence intervals] 0.28 [0.09, 0.84] and 0.50 [0.26, 0.98], respectively) and baseline blood eosinophil count. Conclusions: Mepolizumab reduced the risk of further sinus surgery in patients with recurrent, refractory, severe CRSwNP, irrespective of the patient baseline characteristics assessed. [ABSTRACT FROM AUTHOR]

Published
2023
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14. Mepolizumab for chronic rhinosinusitis with nasal polyps: Treatment efficacy by comorbidity and blood eosinophil count

Author

Bachert, Claus, primary, Sousa, Ana R., additional, Han, Joseph K., additional, Schlosser, Rodney J., additional, Sowerby, Leigh J., additional, Hopkins, Claire, additional, Maspero, Jorge F., additional, Smith, Steven G., additional, Kante, Oliver, additional, Karidi-Andrioti, Despina E., additional, Mayer, Bhabita, additional, Chan, Robert H., additional, Yancey, Steve W., additional, and Chaker, Adam M., additional

Published
2022
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19. Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE): a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Han, Joseph K, primary, Bachert, Claus, additional, Fokkens, Wytske, additional, Desrosiers, Martin, additional, Wagenmann, Martin, additional, Lee, Stella E, additional, Smith, Steven G, additional, Martin, Neil, additional, Mayer, Bhabita, additional, Yancey, Steven W, additional, Sousa, Ana R, additional, Chan, Robert, additional, Hopkins, Claire, additional, Ahlström Emanuelsson, Cecilia, additional, Ardusso, Ledit, additional, Armstrong, Michael, additional, Bardin, Philip, additional, Barnes, Sara, additional, Bergna, Miguel, additional, Betz, Christian, additional, Beule, Achim, additional, Blotter, James, additional, Bronescu, Valeriu, additional, Brown, Matthew, additional, Carrie, Sean, additional, Chaker, Adam, additional, Cho, Hyung-Ju, additional, Corriveau, Marie-Noëlle, additional, Courville, Timothy, additional, Cuevas, Mandy, additional, Damask, Cecelia, additional, DeConde, Adam, additional, Del Carpio, Jaime, additional, De Salvo, María, additional, Dhong, Hun-Jong, additional, Durham, Stephen, additional, Edin, Anton, additional, Ehmer Jr, Dale, additional, Elías, Pedro, additional, Fatakia, Adil, additional, Franzese, Christine, additional, Gane, Simon, additional, García, Gabriel, additional, Gillman, Andrew, additional, Groeger, Moritz, additional, Harvey, Richard, additional, Hellgren, Johan, additional, Higgins, Thomas, additional, Hobson, Jonathan, additional, Jangard, Mattias, additional, Janjua, Arif, additional, Kara, Naveed, additional, Karpischenko, Sergey, additional, Kerwin, Edward, additional, Khanova, Fatimat, additional, Kilty, Shaun, additional, Kim, Chang-Hoon, additional, Kim, Seontae, additional, Klimek, Ludger, additional, LaForce, Craig, additional, Leong, Samuel, additional, Marple, Bradley, additional, Mårtensson, Anders, additional, Maspero, Jorge, additional, Massey, Neil, additional, Matz, Jonathan, additional, McDuffie, Chad, additional, Mella, Corina, additional, Miller, Steven, additional, Mirzabekyan, Ekaterina, additional, Moss, Jonathan, additional, Mumneh, Nayla, additional, Nathan, Robert, additional, Neagos, Adriana, additional, Olze, Heidi, additional, Ovchinnikov, Andrey, additional, Ow, Randall, additional, Polyakov, Dmitriy, additional, Radeanu, Doinel, additional, Rhee, Chae-Seo, additional, Rojas, Ramón, additional, Rosenbloom, Jeffrey, additional, Ryazantsev, Sergei, additional, Sader, Chady, additional, Saez Scherbovsky, Pablo, additional, Scadding, Guy, additional, Schlosser, Rodney, additional, Shah-Patel, Heena, additional, Shealy, Ronald, additional, Siddiqi, Ayesha, additional, Silvers, Stacey, additional, Singh, Narinder, additional, Sommer, Doron, additional, Soong, Weily, additional, Sowerby, Leigh, additional, Spafford, Peter, additional, Stefan, Catalin, additional, Sterling, Richard, additional, Svistushkin, Valeriy, additional, Talreja, Neetu, additional, Tarasova, Galina, additional, Tarpay, Martha, additional, Tolcachier, Alberto, additional, Toll, Karin Toll, additional, van Schaik, Carolina, additional, Webb, Luke, additional, Wedner, H James, additional, Wehbe, Luis, additional, Whan Kim, Soo, additional, Wollenberg, Barbara, additional, Wright, Simon, additional, Yakusevich, Vladimir, additional, Yañez, Anahí, additional, Yarin, Yury, additional, Yen, David, additional, and Yeol Kim, Hyo, additional

Published
2021
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20. Late Breaking Abstract - Response to mepolizumab in patients with severe CRSwNP using EUFOREA 2021 criteria

Author

Hopkins, Claire, primary, Han, Joseph K, additional, Lund, Valerie J, additional, Bachert, Claus, additional, Diamant, Zuzana, additional, Fokkens, Wystke, additional, Sousa, Ana R, additional, Smith, Steven G, additional, Yang, Shibing, additional, Mayer, Bhabita, additional, Yancey, Steve W, additional, Chan, Robert, additional, and Lee, Stella E, additional

Published
2021
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24. Mepolizumab for chronic rhinosinusitis with nasal polyps (SYNAPSE) : A randomised, double-blind, placebo-controlled, phase 3 trial

Author

Han, Joseph K, Bachert, Claus, Fokkens, Wytske, Desrosiers, Martin, Wagenmann, Martin, Lee, Stella E, Smith, Steven G, Martin, Neil, Mayer, Bhabita, Yancey, Steven W, Sousa, Ana R, Chan, Robert, Hopkins, Claire, Han, Joseph K, Bachert, Claus, Fokkens, Wytske, Desrosiers, Martin, Wagenmann, Martin, Lee, Stella E, Smith, Steven G, Martin, Neil, Mayer, Bhabita, Yancey, Steven W, Sousa, Ana R, Chan, Robert, and Hopkins, Claire

Abstract

BACKGROUND: Chronic rhinosinusitis with nasal polyps affects approximately 2-4% of the general population, and long-term use of systemic corticosteroids is associated with adverse effects. The aim of this study was to assess the efficacy and safety of mepolizumab in adults with recurrent, refractory severe bilateral chronic rhinosinusitis with nasal polyps. METHODS: SYNAPSE was a randomised, double-blind, placebo-controlled, parallel-group, phase 3 trial done at 93 centres, mainly hospitals, in 11 countries. Eligible patients were aged 18 years or older with recurrent, refractory, severe, bilateral nasal polyp symptoms (nasal obstruction symptom visual analogue scale [VAS] score of >5), were eligible for repeat nasal surgery (overall symptoms VAS score >7 and endoscopic nasal polyps score of ≥5, with a minimum score of 2 in each nasal cavity) despite standard of care treatment, and had to have at least one nasal surgery in the past 10 years. Patients were randomly assigned (1:1), using permuted block design, to receive either 100 mg mepolizumab subcutaneously or placebo once every 4 weeks, in addition to standard of care (mometasone furoate intranasal spray for at least 8 weeks before screening and during the study, saline nasal irrigations, systemic corticosteroids or antibiotics, or both), as required, for 52 weeks. Site staff, the central study team, and patients were masked to study treatment and absolute blood eosinophil counts. The coprimary endpoints were change from baseline in total endoscopic nasal polyp score at week 52 and in mean nasal obstruction VAS score during weeks 49-52, assessed in the intention-to-treat population (ITT). This study is registered with ClinicalTrials.gov, NCT03085797. FINDINGS: From May 25, 2017, to Dec 12, 2018, 854 patients were screened for eligibility. 414 patients were randomly assigned with 407 included in the ITT population; 206 received mepolizumab and 201 received placebo. Total endoscopic nasal polyp score signific

Published
2021
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25. Mepolizumab for Eosinophil-Associated COPD: Analysis of METREX and METREO

Author

Pavord,Ian, Chapman,Kenneth, Bafadhel,Mona, Sciurba,Frank C, Bradford,Eric S, Schweiker Harris,Stephanie, Mayer,Bhabita, Rubin,David B, Yancey,Steven W, Paggiaro,Pierluigi, Pavord,Ian, Chapman,Kenneth, Bafadhel,Mona, Sciurba,Frank C, Bradford,Eric S, Schweiker Harris,Stephanie, Mayer,Bhabita, Rubin,David B, Yancey,Steven W, and Paggiaro,Pierluigi

Abstract

Ian D Pavord,1 Kenneth R Chapman,2 Mona Bafadhel,1 Frank C Sciurba,3 Eric S Bradford,4 Stephanie Schweiker Harris,4 Bhabita Mayer,5 David B Rubin,4 Steven W Yancey,4 Pierluigi Paggiaro6 1Nuffield Department of Medicine and Oxford Respiratory NIHR BRC, University of Oxford, Oxford, UK; 2Asthma & Airway Centre, UHN and University of Toronto, Toronto, ON, Canada; 3Department of Medicine, University of Pittsburgh, Pittsburgh, PA, USA; 4Respiratory Therapeutic Area, GSK, Research Triangle Park, NC, USA; 5Clinical Statistics, GSK, Brentford, Middlesex, UK; 6Department of Surgery, Medicine, Molecular Biology, and Critical Care, University of Pisa, Pisa, ItalyCorrespondence: Ian D PavordNDM Research Building, Nuffield Department of Medicine and Oxford Respiratory NIHR BRC, University of Oxford, Old Road Campus, Roosevelt Drive, Oxford, OX3 7FZ, UKTel +441865 612897Email ian.pavord@ndm.ox.ac.ukBackground: A pre-specified meta-analysis of individual patient data from the 52-week METREX and METREO trials, which investigated mepolizumab for chronic obstructive pulmonary disease (COPD) in patients with blood eosinophil counts ≥ 150 cells/μL (screening) or ≥ 300 cells/μL (prior year) and frequent exacerbations, enables more robust characterization of mepolizumab efficacy in COPD and exploration of the relationship between blood eosinophil count and treatment responses.Methods: In METREX (117106/NCT02105948) and METREO (117113/NCT02105961), randomized patients received mepolizumab or placebo added to existing inhaled corticosteroid (ICS)–based triple maintenance therapy. The annual rate of moderate/severe exacerbations (primary endpoint) was compared between subcutaneous (SC) mepolizumab 100 mg versus placebo (primary comparison of interest) and all doses (100 mg and 300 mg SC) versus placebo in patients with blood eosinophil counts ≥ 150 cells/μL at screening or ≥ 300 cells/μL in the prior year. Secondary/o

Published
2021

27. Eltrombopag for the treatment of chronic idiopathic thrombocytopenic purpura

Author

Bussel, James B., Cheng, Gregory, Saleh, Mansoor N., Psaila, Bethan, Kovaleva, Lidia, Meddeb, Balkis, Kloczko, Janusz, Hassani, Habib, Mayer, Bhabita, Stone, Nicole L., Arning, Michael, Provan, Drew, and Jenkins, Julian M.

Subjects
Platelet activating factor -- Dosage and administration, Platelet activating factor -- Complications and side effects, Thrombocytopenic purpura -- Drug therapy
Abstract

The results from randomized trial conducted to determine thrombopoietin-receptor agonist eltrombopag as an effective treatment among adults with chronic idiopathic thrombocytopenic purpura (ITP) is reported. Eltrombopag was found to increase platelet counts in a dose-dependent manner in patients with relapsed or refractory ITP.

Published
2007

28. Mepolizumab Improves Health Related Quality of Life for Patients with Chronic Rhinosinusitis with Nasal Polyps: Data from the SYNAPSE study

Author

Lee, Stella, primary, Tabberer, Maggie, additional, Trigg, Andrew, additional, Han, Joseph, additional, Fokkens, Wytske, additional, Naclerio, Robert, additional, Gevaert, Philippe, additional, Sousa, Ana, additional, Howarth, Peter, additional, Mayer, Bhabita, additional, Yancey, Steven, additional, and Chan, Robert, additional

Published
2021
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29. Mepolizumab reduces disease symptoms for Patients with Chronic Rhinosinusitis with Nasal Polyps: Data from the SYNAPSE study

Author

Tabberer, Maggie, primary, Trigg, Andrew, additional, Busse, William, additional, Lund, Valerie, additional, Lee, Jason, additional, Bachert, Claus, additional, Senior, Brent, additional, Buchheit, Kathleen, additional, Diamant, Zuzana, additional, Sousa, Ana, additional, Smith, Steven, additional, Mayer, Bhabita, additional, Yancey, Steven, additional, and Chan, Robert, additional

Published
2021
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32. Validation of a guideline-based composite outcome assessment tool for asthma control

Author

Bendall Kate L, Mayer Bhabita, Spencer Sally, and Bateman Eric D

Subjects
Diseases of the respiratory system, RC705-779
Abstract

Abstract Background A global definition of asthma control does not currently exist. The purpose of this study was to validate two new guideline-based composite measures of asthma control, defined as totally controlled (TC) asthma and well controlled (WC) asthma. Methods We used data from 3416 patients randomised and treated in the multi-centre Gaining Optimal Asthma controL (GOAL) study. The criteria comprising the asthma control measures were based on Global Initiative for Asthma/National Institutes of Health guidelines. This validation study examined the measurement properties of the asthma control measures using data from run-in, baseline, 12 and 52 weeks. Forced expiratory volume in 1 second (FEV1) and the Asthma Quality of Life Questionnaire (AQLQ) were used as the reference criteria in the validation analysis. Results Both measures had good discriminative ability showing significant differences in FEV1 and AQLQ scores between control classification both cross-sectionally and longitudinally (p < 0.001). Overall both of the composite measures accounted for more of the variance in FEV1 after 52 weeks than the individual components of each asthma control measure. Both of the reference criteria were independently related to each asthma control measure (p < 0.0001). The measures also had good predictive validity showing significant differences in FEV1 and AQLQ scores at 52 weeks by control classification at 12 weeks (p < 0.0001). Conclusion The guideline-based composite asthma control measures of WC asthma and TC asthma have good psychometric properties and are both valid functional indices of disease control in asthma.

Published
2007
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38. Treatment policy estimands for recurrent event data using data collected after cessation of randomised treatment.

Author

Roger, James H., Bratton, Daniel J., Mayer, Bhabita, Abellan, Juan J., and Keene, Oliver N.

Subjects
GOVERNMENT policy, OBSTRUCTIVE lung diseases
Abstract

SUMMARY: In the past, many clinical trials have withdrawn subjects from the study when they prematurely stopped their randomised treatment and have therefore only collected 'on‐treatment' data. Thus, analyses addressing a treatment policy estimand have been restricted to imputing missing data under assumptions drawn from these data only. Many confirmatory trials are now continuing to collect data from subjects in a study even after they have prematurely discontinued study treatment as this event is irrelevant for the purposes of a treatment policy estimand. However, despite efforts to keep subjects in a trial, some will still choose to withdraw. Recent publications for sensitivity analyses of recurrent event data have focused on the reference‐based imputation methods commonly applied to continuous outcomes, where imputation for the missing data for one treatment arm is based on the observed outcomes in another arm. However, the existence of data from subjects who have prematurely discontinued treatment but remained in the study has now raised the opportunity to use this 'off‐treatment' data to impute the missing data for subjects who withdraw, potentially allowing more plausible assumptions for the missing post‐study‐withdrawal data than reference‐based approaches. In this paper, we introduce a new imputation method for recurrent event data in which the missing post‐study‐withdrawal event rate for a particular subject is assumed to reflect that observed from subjects during the off‐treatment period. The method is illustrated in a trial in chronic obstructive pulmonary disease (COPD) where the primary endpoint was the rate of exacerbations, analysed using a negative binomial model. [ABSTRACT FROM AUTHOR]

Published
2019
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40. Eltrombopag with gemcitabine‐based chemotherapy in patients with advanced solid tumors: a randomized phase I study

Author

Winer, Eric S., primary, Safran, Howard, additional, Karaszewska, Boguslawa, additional, Richards, Donald A., additional, Hartner, Lee, additional, Forget, Frederic, additional, Ramlau, Rodryg, additional, Kumar, Kirushna, additional, Mayer, Bhabita, additional, Johnson, Brendan M., additional, Messam, Conrad A., additional, and Mostafa Kamel, Yasser, additional

Published
2014
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42. Validation of a guideline-based composite outcome assessment tool for asthma control.

Author

Spencer, Sally, Mayer, Bhabita, Bendall, Late L, Bateman, Eric D, Spencer, Sally, Mayer, Bhabita, Bendall, Late L, and Bateman, Eric D

Abstract

BACKGROUND: A global definition of asthma control does not currently exist. The purpose of this study was to validate two new guideline-based composite measures of asthma control, defined as totally controlled (TC) asthma and well controlled (WC) asthma. METHODS: We used data from 3416 patients randomised and treated in the multi-centre Gaining Optimal Asthma controL (GOAL) study. The criteria comprising the asthma control measures were based on Global Initiative for Asthma/National Institutes of Health guidelines. This validation study examined the measurement properties of the asthma control measures using data from run-in, baseline, 12 and 52 weeks. Forced expiratory volume in 1 second (FEV1) and the Asthma Quality of Life Questionnaire (AQLQ) were used as the reference criteria in the validation analysis. RESULTS: Both measures had good discriminative ability showing significant differences in FEV1 and AQLQ scores between control classification both cross-sectionally and longitudinally (p < 0.001). Overall both of the composite measures accounted for more of the variance in FEV1 after 52 weeks than the individual components of each asthma control measure. Both of the reference criteria were independently related to each asthma control measure (p < 0.0001). The measures also had good predictive validity showing significant differences in FEV1 and AQLQ scores at 52 weeks by control classification at 12 weeks (p < 0.0001). CONCLUSION: The guideline-based composite asthma control measures of WC asthma and TC asthma have good psychometric properties and are both valid functional indices of disease control in asthma.

Published
2007

44. Safety and efficacy of eltrombopag (epag) versus placebo (pbo) for the treatment (tx) of chemotherapy-induced thrombocytopenia (CIT) in patients with solid tumors receiving gemcitabine (gem)-based chemotherapy (ctx): A phase I study.

Author

Winer, Eric S., primary, Safran, Howard, additional, Karaszewska, Boguslawa, additional, Richards, Donald A., additional, Hartner, Lee, additional, Forget, Frederic, additional, Ramlau, Rodryg, additional, Kumar, Kirushna, additional, Mayer, Bhabita, additional, Johnson, Brendan Mark, additional, Messam, Conrad A., additional, and Mostafa Kamel, Yasser Mostafa, additional

Published
2012
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