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1. Age-Related Clinical Characteristics, Inflammatory Features, Phenotypes, and Treatment Response in Asthma.

Author

Wang, J, Zhang, X, Zhang, L, Liu, Y, Wang, G, Zhang, HP, Wang, L, Kang, DY, Oliver, BG, Wan, HJ, McDonald, VM, Chen-Yu Hsu, A, Liu, D, Li, WM, Birring, SS, Wang, J, Zhang, X, Zhang, L, Liu, Y, Wang, G, Zhang, HP, Wang, L, Kang, DY, Oliver, BG, Wan, HJ, McDonald, VM, Chen-Yu Hsu, A, Liu, D, Li, WM, and Birring, SS

Abstract

BACKGROUND: Emerging evidence suggests that aging affects asthma outcomes, but the mechanism remains largely unexplored. OBJECTIVE: To explore age-related clinical characteristics, inflammatory features, phenotypes, and treatment response in asthma. METHODS: This was a prospective cohort study of asthmatic patients with a 12-month follow-up in a real-world setting. Clinical inflammatory and phenotypic characteristics, future risk for exacerbations, and treatment response were assessed across different age groups (young was defined as age 18 to 39 years; middle-aged, 40 to 64 years; and elderly, 65 years or older). RESULTS: Compared with young (n = 106) and middle-aged (n = 179) asthmatic patients, elderly patients (n = 55) had worse airway obstruction, more comorbidities including chronic obstructive pulmonary disease and diabetes, less atopy, and lower levels of IgE and FeNO, and were more likely to have late-onset and fixed airflow obstruction asthma and a reduced risk for having type 2 profile asthma. Levels of IFN-gamma, IL-17A, and IL-8 in induced sputum were significantly increased in elderly asthmatic patients (all P < .05). Path analysis indicated that age directly and significantly led to future exacerbations in asthma, partially mediated by an upregulation of airway IFN-gamma. Moreover, elderly patients with asthma had a reduced treatment response (improvement in FEV1 of 12% or greater, or 200 mL, and a reduction in Borg scores of 1 or greater) (adjusted odds ratio = 0.11; 95% CI, 0.02-0.52; and adjusted odds ratio = 0.12; 95% CI, 0.03-0.49, respectively). CONCLUSIONS: This study confirms that asthma in the elderly population represents a specific phenotype and indicates that aging can influence asthma in terms of clinical characteristics, inflammatory features, exacerbations, and treatment response.

Published
2023

2. Validation and Meaningful Change Thresholds for an Objective Cough Frequency Measurement in Chronic Cough

Author

Smith, Jaclyn, Schelfhout, J, Nguyen, AM, Birring, SS, Bacci, ED, Vernon, M, Muccino, DR, La, Rosa C, and Smith, JA

Subjects
Pulmonary and Respiratory Medicine, Clinically meaningful change, Patient-reported outcomes, Cough, ROC Curve, Objective cough frequency, Chronic cough, Cough monitoring, Humans, Patient Reported Outcome Measures, Plastic Surgery Procedures, Pain Measurement, Cough severity
Abstract

Purpose Objective cough frequency is used to assess efficacy of chronic cough (CC) treatments. The objective of this study was to explore the relationship between objective cough frequency and cough-specific patient-reported outcomes (PROs) and estimate a clinically meaningful change threshold (MCT) for objective cough frequency. Methods Data collected in a phase 2b study in participants with refractory or unexplained CC were used to investigate the relationship between 24-h cough frequency (measured using an ambulatory cough monitor) and cough-specific PROs (i.e., cough severity visual analog scale, cough severity diary, Leicester Cough Questionnaire). Convergent validity was assessed using Spearman ρ. An MCT for 24-h cough frequency was estimated using the patient global impression of change (PGIC) scale as an anchor. Results Correlations between 24-h cough frequency and cough-specific PROs at baseline, Week 4, and Week 12 were significant (P ρ = 0.30–0.58). Participants categorized as very much improved/much improved (i.e., PGIC of 1 or 2) or minimally improved (i.e., PGIC of 3) had mean 24-h cough frequency reductions of 55% and 30%, respectively. Receiver operating characteristic curve analysis suggested that a 24-h cough frequency reduction of 38% optimizes sensitivity and specificity for predicting a PGIC score of 1–3. Conclusion Objective 24-h cough frequency is significantly associated with cough-specific PROs, but cough frequency and PROs most likely capture distinct aspects of CC. A ≥ 30% reduction in 24-h cough frequency is a reasonable MCT to define treatment response in CC clinical trials.

Published
2022

6. P59 Baseline characteristics and medical history of patients with refractory or unexplained chronic cough participating in two global phase 3 clinical trials

Author

McGarvey, L, primary, Birring, SS, additional, Dicpinigaitis, P, additional, Morice, A, additional, Pavord, I, additional, Smith, JA, additional, Iskold, B, additional, Li, Q, additional, Martin Nguyen, A, additional, Schelfhout, J, additional, Tzontcheva, A, additional, La Rosa, C, additional, and Muccino, D, additional

Published
2021
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10. P60 Patient-reported improvements with gefapixant, a P2X3-receptor antagonist, over 52 weeks in two phase 3 clinical trials for refractory or unexplained chronic cough

Author

Birring, SS, primary, Dicpinigaitis, P, additional, Morice, A, additional, Smith, JA, additional, McGarvey, L, additional, Pavord, I, additional, Martin Nguyen, A, additional, Schelfhout, J, additional, Tzontcheva, A, additional, Li, Q, additional, La Rosa, C, additional, and Muccino, D, additional

Published
2021
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11. Global Physiology and Pathophysiology of Cough Part 1: Cough Phenomenology - CHEST Guideline and Expert Panel Report

Author

Lee, KK, Davenport, PW, Smith, JA, Irwin, RS, McGarvey, L, Mazzone, SB, Birring, SS, Lee, KK, Davenport, PW, Smith, JA, Irwin, RS, McGarvey, L, Mazzone, SB, and Birring, SS

Abstract

The purpose of this state-of-the-art review is to update the American College of Chest Physicians 2006 guideline on global physiology and pathophysiology of cough. A review of the literature was conducted using PubMed and MEDLINE databases from 1951 to 2019 and using prespecified search terms. We describe the basic phenomenology of cough patterns, behaviors, and morphological features. We update the understanding of mechanical and physiological characteristics of cough, adding a contemporary view of the types of cough and their associated behaviors and sensations. New information about acoustic characteristics is presented, and recent insights into cough triggers and the patient cough hypersensitivity phenotype are explored. Lastly, because the clinical assessment of patients largely focuses on the duration rather than morphological features of cough, we review the morphological features of cough that can be measured in the clinic. This is the first of a two-part update to the American College of Chest Physicians 2006 cough guideline; it provides a more global consideration of cough phenomenology, beyond simply the mechanical aspects of a cough. A greater understanding of the typical features of cough, and their variations, may allow a more informed interpretation of cough measurements and the clinical relevance for patients.

Published
2021

12. Confronting COVID-19-associated cough and the post-COVID syndrome: role of viral neurotropism, neuroinflammation, and neuroimmune responses

Author

Song, W-J, Hui, CKM, Hull, JH, Birring, SS, McGarvey, L, Mazzone, SB, Chung, KF, Song, W-J, Hui, CKM, Hull, JH, Birring, SS, McGarvey, L, Mazzone, SB, and Chung, KF

Abstract

Cough is one of the most common presenting symptoms of COVID-19, along with fever and loss of taste and smell. Cough can persist for weeks or months after SARS-CoV-2 infection, often accompanied by chronic fatigue, cognitive impairment, dyspnoea, or pain-a collection of long-term effects referred to as the post-COVID syndrome or long COVID. We hypothesise that the pathways of neurotropism, neuroinflammation, and neuroimmunomodulation through the vagal sensory nerves, which are implicated in SARS-CoV-2 infection, lead to a cough hypersensitivity state. The post-COVID syndrome might also result from neuroinflammatory events in the brain. We highlight gaps in understanding of the mechanisms of acute and chronic COVID-19-associated cough and post-COVID syndrome, consider potential ways to reduce the effect of COVID-19 by controlling cough, and suggest future directions for research and clinical practice. Although neuromodulators such as gabapentin or opioids might be considered for acute and chronic COVID-19 cough, we discuss the possible mechanisms of COVID-19-associated cough and the promise of new anti-inflammatories or neuromodulators that might successfully target both the cough of COVID-19 and the post-COVID syndrome.

Published
2021

13. Treatable Traits in Elderly Asthmatics from the Australasian Severe Asthma Network: A Prospective Cohort Study.

Author

Wu, WW, Zhang, X, Li, M, Liu, Y, Chen, ZH, Xie, M, Zhao, SZ, Wang, G, Zhang, HP, Wang, T, Qin, L, Wang, L, Oliver, BG, Wan, HJ, Zhang, J, McDonald, VM, Marks, GB, Li, WM, Birring, SS, Gibson, PG, Wu, WW, Zhang, X, Li, M, Liu, Y, Chen, ZH, Xie, M, Zhao, SZ, Wang, G, Zhang, HP, Wang, T, Qin, L, Wang, L, Oliver, BG, Wan, HJ, Zhang, J, McDonald, VM, Marks, GB, Li, WM, Birring, SS, and Gibson, PG

Abstract

BACKGROUND: Data on treatable traits (TTs) in different populations are limited. OBJECTIVE: To assess TTs in elderly patients with asthma and compare them to younger patients, to evaluate the association of TTs with future exacerbations, and to develop an exacerbation prediction model. METHODS: We consecutively recruited 521 participants at West China Hospital, Sichuan University based on the Australasian Severe Asthma Network, classified as elderly (n = 62) and nonelderly (n = 459). Participants underwent a multidimensional assessment to characterize the TTs and were then followed up for 12 months. TTs and their relationship with future exacerbations were described. Based on the TTs and asthma control levels, an exacerbation prediction model was developed, and the overall performance was externally validated in an independent cohort. RESULTS: A total of 38 TTs were assessed. Elderly patients with asthma had more chronic metabolic diseases, fixed airflow limitation, emphysema, and neutrophilic inflammation, whereas nonelderly patients with asthma exhibited more allergic characteristics and psychiatric diseases. Nine traits were associated with increased future exacerbations, of which exacerbation prone, upper respiratory infection-induced asthma attack, cardiovascular disease, diabetes, and depression were the strongest. A model including exacerbation prone, psychiatric disease, cardiovascular disease, upper respiratory infection-induced asthma attack, noneosinophilic inflammation, cachexia, food allergy, and asthma control was developed to predict exacerbation risk and showed good performance. CONCLUSIONS: TTs can be systematically assessed in elderly patients with asthma, some of which are associated with future exacerbations, proving their clinical utility of evaluating them. A model based on TTs can be used to predict exacerbation risk in people with asthma.

Published
2021

15. Managing the supportive care needs of those affected by COVID-19.

Author

Bajwah, S, Wilcock, A, Towers, R, Costantini, M, Bausewein, C, Simon, ST, Bendstrup, E, Prentice, W, Johnson, MJ, Currow, DC, Kreuter, M, Wells, AU, Birring, SS, Edmonds, P, Higginson, IJ, Bajwah, S, Wilcock, A, Towers, R, Costantini, M, Bausewein, C, Simon, ST, Bendstrup, E, Prentice, W, Johnson, MJ, Currow, DC, Kreuter, M, Wells, AU, Birring, SS, Edmonds, P, and Higginson, IJ

Published
2020

17. New understanding in the treatment of cough (NEUROCOUGH) ERS Clinical Research Collaboration: improving care and treatment for patients with cough

Author

McGarvey, L, Dupont, L, Birring, SS, Boyd, J, Chung, KF, Dabrowska, M, Domingo, C, Fontana, G, Guilleminault, L, Kardos, P, Millqvist, E, Morice, AH, Smith, JA, Van den Berg, JW, Van de Kerkhove, C, Coleman, C, Adcock, I, Dicpinigaitis, P, Geppetti, P, Gibson, P, Lai, K, Mazzone, S, Page, C, Pavord, I, Song, W-J, Queen's University [Belfast] (QUB), Catholic University of Leuven - Katholieke Universiteit Leuven (KU Leuven), King‘s College London, The European Lung Foundation (ELF), Imperial College London, Medical University of Warsaw - Poland, Universitat Autònoma de Barcelona (UAB), Università degli Studi di Firenze = University of Florence (UniFI), Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Centre de Physiopathologie Toulouse Purpan (CPTP), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Red Cross Maingau Hospital = Klinik Maingau vom Roten Kreuz, University of Gothenburg (GU), Castle Hill Hospital, University of Manchester [Manchester], Isala Hospital, Universitair Ziekenhuis Leuven (UZ Leuven), Benson-Rumiz, Alicia, and Pavord, I

Subjects
Pulmonary and Respiratory Medicine, medicine.medical_specialty, IMPACT, International Cooperation, education, MESH: Societies, Medical, Respiratory System, RECOMMENDATIONS, Double blind, 03 medical and health sciences, DOUBLE-BLIND, 0302 clinical medicine, medicine, Humans, COPD, 030212 general & internal medicine, MESH: Quality of Health Care, Intensive care medicine, MESH: Antitussive Agents / therapeutic use, Societies, Medical, health care economics and organizations, 11 Medical and Health Sciences, Quality of Health Care, Focus (computing), MESH: Humans, [SDV.MHEP] Life Sciences [q-bio]/Human health and pathology, Science & Technology, NEUROCOUGH Clinical Research Collaboration, business.industry, medicine.disease, Europe, RECEPTORS, Antitussive Agents, MESH: International Cooperation, Clinical research, Cough, 030228 respiratory system, Antitussive Agent, MESH: Cough / drug therapy, MESH: Europe, business, Life Sciences & Biomedicine, [SDV.MHEP]Life Sciences [q-bio]/Human health and pathology
Abstract

Chronic cough is a common and troublesome clinical problem and currently there are no effective treatments [1]. While individual specialist cough clinics have been set up in some European countries, there is no formal mechanism to develop common management approaches. Furthermore, the vast majority of clinical trials of novel anti-tussive treatment have been conducted in a limited number of sites in the UK and USA, with little in the way of cough clinical trial infrastructure across Europe [2–7]. The NEw Understanding in the tReatment Of COUGH (NEUROCOUGH) Clinical Research Collaboration (CRC) seeks to address this through creating a platform allowing clinicians, together with researchers in academia and industrial partners across Europe and beyond, to exchange ideas and facilitate collaborations geared towards improved care and treatment for patients with cough. The core aims of NEUROCOUGH are to: 1) create a registry of Europe-wide specialist cough clinics operating according to agreed and standardised protocols; 2) establish a Europe-wide registry of “clinical trial ready” chronic cough patients suitable for multicentre experimental medicine studies and later phase precision medicine clinical trials; 3) seek public engagement to provide input into NEUROCOUGH based on the priorities and unmet needs of patients; and 4) encourage early career researchers and clinicians into the field of cough. In time, we envisage that NEUROCOUGH will bring clinicians, scientists, patients and industry together for larger-scale cough projects in a way that to date has not been possible. NEUROCOUGH will place Europe at the forefront of clinical improvements in chronic cough and provide a strong platform for attracting major clinical trials of anti-tussives, thus speeding up drug discovery with the ultimate aim of providing better treatments for patients with chronic cough.

Published
2019

18. S27 A placebo-controlled, double-blind, randomised, crossover study to assess the efficacy, safety and tolerability of TRPV4 inhibitor GSK2798745 in participants with chronic cough

Author

Ludbrook, VJ, primary, Hanrott, KE, additional, Marks-Konczalik, J, additional, Kreindler, JL, additional, Bird, NP, additional, Hewens, D, additional, Beerahee, M, additional, Behm, DJ, additional, Morice, A, additional, McGarvey, L, additional, Parker, SM, additional, Birring, SS, additional, and Smith, J, additional

Published
2019
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24. Best supportive care for idiopathic pulmonary fibrosis: Current gaps and future directions

Author

Ferrara, G, Luppi, F, Birring, S, Cerri, S, Caminati, A, Sköld, M, Kreuter, M, Birring, SS, Ferrara, G, Luppi, F, Birring, S, Cerri, S, Caminati, A, Sköld, M, Kreuter, M, and Birring, SS

Abstract

Best supportive care (BSC) is generally defined as all the interventions and the multiprofessional approach aimed to improve and optimise quality of life (QoL) in patients affected by progressive diseases. In this sense, it excludes and might be complementary to other interventions directly targeting the disease. BSC improves survival in patients with different types of cancer. Patients with idiopathic pulmonary fibrosis (IPF) experience a vast range of symptoms during the natural history of the disease and might have a beneficial effect of BSC interventions. This review highlights the current evidence on interventions targeting QoL and gaps for the clinical assessment of BSC in the treatment of IPF patients. Very few interventions to improve QoL or improve symptom control are currently supported by well-designed studies. Sound methodology is paramount in evaluating BSC in IPF, as well as the use of validated tools to measure QoL and symptom control in this specific group of patients.

Published
2018

26. Effect of pirfenidone on cough in patients with idiopathic pulmonary fibrosis

Author

van Manen, Mirjam, Birring, SS, Vancheri, C, Vindigni, V, Renzoni, E, Russell, A M, Korver, Monique, Cottin, V, Wijsenbeek - Lourens, Marlies, van Manen, Mirjam, Birring, SS, Vancheri, C, Vindigni, V, Renzoni, E, Russell, A M, Korver, Monique, Cottin, V, and Wijsenbeek - Lourens, Marlies

Published
2017

27. Peptic ulceration, Helicobacter pylori seropositivity and chronic obstructive pulmonary disease

Author

Siva, R, Birring, SS, Berry, M, Rowbottom, A, and Pavord, ID

Abstract

BACKGROUND AND OBJECTIVE: We have suggested that chronic inflammation of other foregut derivatives might be associated with airway inflammation and amplification of the response to inhaled stimuli such as cigarette smoke leading to chronic obstructive pulmonary disease (COPD). One of the commonest causes of chronic foregut inflammation is gastritis secondary to Helicobacter Pylori infection. We tested the hypothesis that peptic ulceration and H. Pylori seropositivity are associated with COPD independently of other shared risk factors. METHODS: We reviewed primary care medical records and performed full lung function tests on 329 miners seen over 2 years as part of a compensation scheme. We also performed H. Pylori serology in patients with varying degrees of severity of COPD compared with a matched control population. RESULTS: The prevalence of peptic ulcer disease in the groups classed as normal, chronic bronchitis, mild, moderate and severe COPD was 3.2%, 16.2%, 21.4%, 42.4% and 56.2%, respectively. There was a strong and independent relationship between the presence of peptic ulcer disease and percent of predicted forced expiratory volume in 1 s (-13.3%; 95% confidence interval: 6.7-19.9; P

Published
2016

30. S57 Predictors of uptake of ambulatory oxygen on completion of the ambox trial, a study to assess effects of ambulatory oxygen on quality of life in patients with fibrotic interstitial lung disease

Author

Mori, L, primary, Canu, S, additional, Visca, D, additional, Tsipouri, V, additional, Bonini, M, additional, Pavitt, M, additional, Fleming, S, additional, Firouzi, A, additional, Farquhar, M, additional, Leung, E, additional, Hogben, C, additional, Lauretis, A De, additional, Kokosi, M, additional, George, PM, additional, Molyneaux, PL, additional, Brown, J, additional, Rippon, N, additional, Chetta, A, additional, Russell, AM, additional, Saunders, P, additional, Kouranos, V, additional, Margaritopoulos, G, additional, Maher, TM, additional, Stockford, A, additional, Hopkinson, N, additional, Birring, SS, additional, Wells, AU, additional, Banya, W, additional, Adamali, H, additional, Spencer, L, additional, and Sestini, P, additional

Published
2017
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32. P103 The urge to cough in copd

Author

Solomon, A, primary, Cho, PS P, additional, Fletcher, H, additional, Patel, IS, additional, Jolley, CJ, additional, Turner, RD, additional, and Birring, SS, additional

Published
2017
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34. Cough in idiopathic pulmonary fibrosis

Author

van Manen, Mirjam, Birring, SS, Vancheri, C, Cottin, V, Renzoni, E A, Russell, A M, Wijsenbeek - Lourens, Marlies, van Manen, Mirjam, Birring, SS, Vancheri, C, Cottin, V, Renzoni, E A, Russell, A M, and Wijsenbeek - Lourens, Marlies

Published
2016

35. Reconciling Healthcare Professional and Patient Perspectives in the Development of Disease Activity and Response Criteria in Connective Tissue Disease Related Interstitial Lung Diseases

Author

Saketkoo, La, Mittoo, S, Frankel, S, Lesage, D, Sarver, C, Phillips, K, Strand, V, Matteson, El, OMERACT Baughman RP, Brown, Kk, Christmann, Rb, Dellaripa, P, Denton, Cp, Distler, O, Fischer, A, Flaherty, K, Huscher, D, Khanna, D, Kowal Bielecka, O, Merkel, Pa, Oddis, Cv, Pittrow, D, Sandorfi, N, Seibold, Jr, Swigris, J, Wells, A, Antoniou, K, Castelino, Fv, Christopher Stine, L, Collard, Hr, Cottin, V, Danoff, S, Hedlund, R, Highland, Kb, Hummers, L, Lynch, Da, Kim, Ds, Ryu, Jh, Miller, Fw, Nichols, K, Proudman, Sm, Richeldi, L, Shah, Aa, van den Assum, P, Aggarwal, R, Ainslie, G, Alkassab, F, Allanore, Y, Anderson, Me, Andonopoulos, Ap, Antin Ozerkis, D, Arrobas, A, Ascherman, Dp, Assassi, S, Baron, M, Bathon, Jm, Baughman, Rp, Behr, J, Beretta, L, Bingham, Co, Binnie, M, Birring, Ss, Boin, F, Bongartz, T, Bourdin, A, Bouros, D, Brasington, R, Bresser, P, Buch, Mh, Burge, Ps, Carmona, L, Carreira, Pe, Carvalho, Cr, Catoggio, Lj, Chan, Km, Chapman, J, Chatterjee, S, Chua, F, Chung, L, Conron, M, Corte, T, Cosgrove, G, Costabel, U, Cox, G, Crestani, B, Crofford, Lj, Csuka, Me, Curbelo, P, Czirják, L, Daniil, Z, D'Arsigny, Cl, Davis, Gs, de Andrade JA, Dellaripa, Pf, De Vuyst, P, Dempsey, Oj, Derk, Ct, Distler, J, Dixon, Wg, Downey, G, Doyle, Mk, Drent, M, Durairaj, L, Emery, P, Espinoza, Lr, Farge, D, Fathi, M, Fell, Cd, Fessler, Bj, Fitzgerald, Je, Flaherty, Kr, Foeldvari, I, Fox, Ga, Frech, Tm, Freitas, S, Furst, De, Gabrielli, A, García Vicuña, R, Georgiev, Ob, Gerbino, A, Gillisen, A, Gladman, Dd, Glassberg, M, Gochuico, Br, Gogali, A, Goh, Ns, Goldberg, A, Goldberg, Hj, Gourley, Mf, Griffing, L, Grutters, Jc, Gunnarsson, R, Hachulla, E, Hall, Fc, Harari, S, Herrick, Al, Herzog, El, Hesselstrand, R, Highland, K, Hirani, N, Hodgson, U, Hollingsworth, Hm, Homer, Rj, Hoyles, Rk, Hsu, Vm, Hubbard, Rb, Hunzelmann, N, Isasi, Me, Isasi, Es, Jacobsen, S, Jimenez, Sa, Johnson, Sr, Jones, Ch, Kahaleh, B, Kairalla, Ra, Kalluri, M, Kalra, S, Kaner, Rj, Kinder, Bw, Kiter, G, Klingsberg, Rc, Kokosi, M, Kolb, Mr, Kowal Bielecka OM, Kur Zalewska, J, Kuwana, M, Lake, Fr, Lally, Ev, Lasky, Ja, Laurindo, Im, Able, L, Lee, P, Leonard, Ct, Lien, Dc, Limper, Ah, Liossis, Sn, Lohr, Km, Loyd, Je, Lundberg, Ie, Mageto, Yn, Maher, Tm, Mahmud, Th, Manganas, H, Marie, I, Marras, Tk, Martinez, Ja, Martinez, Fj, Mathieu, A, Matucci Cerinic, M, Mayes, Md, Mckown, Km, Medsger, Ta, Meehan, Rt, Mendes, Ac, Meyer, Kc, Millar, Ab, Moğulkoc, N, Molitor, Ja, Morais, A, Mouthon, L, Müller, V, Müller Quernheim, J, Nadashkevich, O, Nador, R, Nash, P, Nathan, Sd, Navarro, C, Neves, S, Noth, I, Nunes, H, Olson, Al, Opitz, Cf, Padilla, M, Pappas, D, Parfrey, H, Pego Reigosa JM, Pereira, Ca, Perez, R, Pope, Je, Porter, Jc, Renzoni, Ea, Riemekasten, G, Riley, Dj, Rischmueller, M, Rodriguez Reyna TS, Rojas Serrano, J, Roman, J, Rosen, Gd, Rossman, M, Rothfield, N, Sahn, Sa, Sanduzzi, A, Scholand, Mb, Selman, M, Senécal, Jl, Seo, P, Shah, A, Silver, Rm, Solomon, Jj, Steen, V, Stevens, W, Strange, C, Sussman, R, Sutton, Ed, Sweiss, Nj, Tornling, G, Tzelepis, Ge, Undurraga, A, Vacca, A, Vancheri, Carlo, Varga, J, Veale, Dj, Volkov, S, Walker, Ua, Wells, Au, Wencel, M, Wesselius, Lj, Wickremasinghe, M, Wilcox, P, Wilsher, Ml, Wollheim, Fa, Wuyts, Wa, Yung, G, Zanon, P, Zappala, Cj, Groshong, Sd, Leslie, Ko, Myers, Jl, Padera, Rf, Desai, Sr, Goldin, J, Kazerooni, Ea, Klein, Js, and Keen, Kj

Subjects
Male, medicine.medical_specialty, Delphi Technique, Consensus Development Conferences as Topic, Health Personnel, Immunology, Context (language use), Disease, Severity of Illness Index, Article, Idiopathic pulmonary fibrosis, Rheumatology, medicine, Immunology and Allergy, Humans, Disease management (health), Intensive care medicine, Connective Tissue Diseases, Randomized Controlled Trials as Topic, business.industry, Interstitial lung disease, Disease Management, respiratory system, Focus Groups, medicine.disease, Comorbidity, Connective tissue disease, respiratory tract diseases, Clinical trial, Treatment Outcome, Patient Satisfaction, Physical therapy, Quality of Life, ÍNDICE DE GRAVIDADE DA DOENÇA, Interdisciplinary Communication, business, Lung Diseases, Interstitial
Abstract

Interstitial lung diseases (ILD), including those related to connective tissue disease (CTD), and idiopathic pulmonary fibrosis (IPF) carry high morbidity and mortality. Great efforts are under way to develop and investigate meaningful treatments in the context of clinical trials. However, efforts have been challenged by a lack of validated outcome measures and by inconsistent use of measures in clinical trials. Lack of consensus has fragmented effective use of strategies in CTD-ILD and IPF, with a history of resultant difficulties in obtaining agency approval of treatment interventions. Until recently, the patient perspective to determine domains and outcome measures in CTD-ILD and IPF had never been applied. Efforts described here demonstrate unequivocally the value and influence of patient involvement on core set development. Regarding CTD-ILD, this is the first OMERACT working group to directly address a manifestation/comorbidity of a rheumatic disease (ILD) as well as a disease not considered rheumatic (IPF). The OMERACT 11 proceedings of the CTD-ILD Working Group describe the forward and lateral process to include both the medical and patient perspectives in the urgently needed identification of a core set of preliminary domains and outcome measures in CTD-ILD and IPF.

Published
2014

36. Connective tissue disease related interstitial lung diseases and idiopathic pulmonary fibrosis: Provisional core sets of domains and instruments for use in clinical trials

Author

Saketkoo, La, Mittoo, S, Huscher, D, Khanna, D, Dellaripa, Pf, Distler, O, Flaherty, Kr, Frankel, S, Oddis, Cv, Denton, Cp, Fischer, A, Kowal Bielecka OM, Lesage, D, Merkel, Pa, Phillips, K, Pittrow, D, Swigris, J, Antoniou, K, Baughman, Rp, Castelino, Fv, Christmann, Rb, Christopher Stine, L, Collard, Hr, Cottin, V, Danoff, S, Highland, Kb, Hummers, L, Shah, Aa, Kim, Ds, Lynch, Da, Miller, Fw, Proudman, Sm, Richeldi, L, Ryu, Jh, Sandorfi, N, Sarver, C, Wells, Au, Strand, V, Matteson, El, Brown, Kk, Seibold, Jr, Aggarwal, R, Ainslie, G, Alkassab, F, Allanore, Y, Descartes, P, Anderson, Me, Andonopoulos, Ap, Antin Ozerkis, D, Arrobas, A, Ascherman, Dp, Assassi, S, Baron, M, Bathon, Jm, Behr, J, Beretta, L, Bingham, Co, Binnie, M, Birring, Ss, Boin, F, Bongartz, T, Bourdin, A, Bouros, D, Brasington, R, Bresser, P, Buch, Mh, Burge, Ps, Carmona, L, Carreira, Pe, Carvalho, Cr, Catoggio, Lj, Chan, Km, Chapman, J, Chatterjee, S, Chua, F, Chung, L, Conron, M, Corte, T, Cosgrove, G, Costabel, U, Cox, G, Crestani, B, Crofford, Lj, Csuka, Me, Curbelo, P, László, C, Daniil, Z, D'Arsigny, Cl, Davis, Gs, de Andrade JA, De Vuyst, P, Dempsey, Oj, Derk, Ct, Distler, J, Dixon, Wg, Downey, G, Doyle, Mk, Drent, M, Durairaj, L, Emery, P, Espinoza, Lr, Farge, D, Fathi, M, Fell, Cd, Fessler, Bj, Fitzgerald, Je, Fox, Ga, Foeldvari, I, Frech, Tm, Freitas, S, Furst, De, Gabrielli, A, García Vicuña, R, Georgiev, Ob, Gerbino, A, Gillisen, A, Gladman, Dd, Glassberg, M, Gochuico, Br, Gogali, A, Goh, Ns, Goldberg, A, Goldberg, Hj, Gourley, Mf, Griffing, L, Grutters, Jc, Gunnarsson, R, Hachulla, E, Hall, Fc, Harari, S, Herrick, Al, Herzog, El, Hesselstrand, R, Hirani, N, Hodgson, U, Hollingsworth, Hm, Homer, Rj, Hoyles, Rk, Hsu, Vm, Hubbard, Rb, Hunzelmann, N, Isasi, Me, Isasi, Es, Jacobsen, S, Jimenez, Sa, Johnson, Sr, Jones, Ch, Kahaleh, B, Kairalla, Ra, Kalluri, M, Kalra, S, Kaner, Rj, Kinder, Bw, Klingsberg, Rc, Kokosi, M, Kolb, Mr, Kur Zalewska, J, Kuwana, M, Lake, Fr, Lally, Ev, Lasky, Ja, Laurindo, Im, Able, L, Lee, P, Leonard, Ct, Lien, Dc, Limper, Ah, Liossis, Sn, Lohr, Km, Loyd, Je, Lundberg, Ie, Mageto, Yn, Maher, Tm, Mahmud, Th, Manganas, H, Marie, I, Marras, Tk, Antônio Baddini Martinez, J, Martinez, Fj, Mathieu, A, Matucci Cerinic, M, Mayes, Md, Mckown, Km, Medsger, Ta, Meehan, Rt, Cristina, Ma, Meyer, Kc, Millar, Ab, Moğulkoc, N, Molitor, Ja, Morais, A, Luc Mouthon, P, Müller, V, Müller Quernheim, J, Nadashkevich, O, Nador, R, Nash, P, Nathan, Sd, Navarro, C, Neves, S, Noth, I, Nunes, H, Olson, Al, Opitz, Cf, Padilla, M, Pappas, D, Parfrey, H, Pego Reigosa JM, Pereira, Ca, Perez, R, Pope, Je, Porter, Jc, Renzoni, Ea, Riemekasten, G, Riley, Dj, Rischmueller, M, Rodriguez Reyna TS, Rojas, Serrano, Roman, J, Rosen, Gd, Rossman, M, Rothfield, N, Sahn, Sa, Sanduzzi, A, Scholand, Mb, Selman, M, Senécal, Jl, Seo, P, Silver, Rm, Solomon, Jj, Steen, V, Stevens, W, Strange, C, Sussman, R, Sutton, Ed, Sweiss, Nj, Tornling, G, Tzelepis, Ge, Undurraga, A, Vacca, A, Vancheri, Carlo, Varga, J, Veale, Dj, Volkov, S, Walker, Ua, Wencel, M, Wesselius, Lj, Wickremasinghe, M, Wilcox, P, Wilsher, Ml, Wollheim, Fa, Wuyts, Wa, Yung, G, Zanon, P, Zappala, Cj, Groshong, Sd, Leslie, Ko, Myers, Jl, Padera, Rf, Desai, Sr, Goldin, J, Kazerooni, Ea, Klein, Js, Cenac, Sl, Grewal, Hk, Christensen, Am, Ferguson, S, Tran, M, Keen, K. J., Costabel, Ulrich (Beitragende*r), Raynauds & Scleroderma Association, Arthritis Research UK, The Scleroderma Society, and British Lung Foundation

Subjects
Lung Diseases, Connective tissue disease associated lung disease, CTD-ILD Special Interest Group, International Cooperation, Respiratory System, Medizin, Rheumatoid lung disease, Idiopathic pulmonary fibrosis, Quality of life, QUALITY-OF-LIFE, CYCLOPHOSPHAMIDE, SCLERODERMA LUNG, Registries, Connective Tissue Diseases, Societies, Medical, Randomized Controlled Trials as Topic, Interstitial lung disease, respiratory system, Connective tissue disease, Interstitial Fibrosis, medicine.anatomical_structure, Life Sciences & Biomedicine, Pulmonary and Respiratory Medicine, medicine.medical_specialty, Consensus, Clinical Sciences, END-POINT, Interstitial Lung Disease, Systemic disease and lungs, Medical, medicine, Humans, ENSAIO CLÍNICO CONTROLADO RANDOMIZADO, VALIDITY, Intensive care medicine, Lung, Science & Technology, COUGH, business.industry, Clinical study design, MORTALITY, SYSTEMIC-SCLEROSIS, 1103 Clinical Sciences, Congresses as Topic, medicine.disease, GEORGES RESPIRATORY QUESTIONNAIRE, respiratory tract diseases, Clinical trial, IPF, Physical therapy, Interstitial, Societies, business, Lung Diseases, Interstitial
Abstract

Rationale: Clinical trial design in interstitial lung diseases (ILDs) has been hampered by lack of consensus on appropriate outcome measures for reliably assessing treatment response. In the setting of connective tissue diseases (CTDs), some measures of ILD disease activity and severity may be confounded by non-pulmonary comorbidities. Methods: The Connective Tissue Disease associated Interstitial Lung Disease (CTD-ILD) working group of Outcome Measures in Rheumatology-a non-profit international organisation dedicated to consensus methodology in identification of outcome measures-conducted a series of investigations which included a Delphi process including >248 ILD medical experts as well as patient focus groups culminating in a nominal group panel of ILD experts and patients. The goal was to define and develop a consensus on the status of outcome measure candidates for use in randomised controlled trials in CTD-ILD and idiopathic pulmonary fibrosis (IPF). Results: A core set comprising specific measures in the domains of lung physiology, lung imaging, survival, dyspnoea, cough and health-related quality of life is proposed as appropriate for consideration for use in a hypothetical 1-year multicentre clinical trial for either CTD-ILD or IPF. As many widely used instruments were found to lack full validation, an agenda for future research is proposed. Conclusion: Identification of consensus preliminary domains and instruments to measure them was attained and is a major advance anticipated to facilitate multicentre RCTs in the field.

Published
2014

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