Imperial College London

Professor Anand Devaraj

Faculty of MedicineNational Heart & Lung Institute

Professor of Practice (Thoracic Radiology)
 
 
 
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Contact

 

anand.devaraj Website

 
 
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Location

 

South BlockRoyal Brompton Campus

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Summary

 

Publications

Publication Type
Year
to

283 results found

Bax S, Jacobs J, Kouranos V, Bredy C, Dimopoulos K, Kempny A, Walsh S, Nair A, Kokosi M, Kier G, Renzoni E, Chua F, George P, Mccabe C, Wilde M, Devaraj A, Wells A, Price L, Wort SJet al., 2018, 10 years' experience of referral of ILD patients with Suspected PH to a National PH Service: Demographics and Outcomes, 28th International Congress of the European-Respiratory-Society (ERS), Publisher: EUROPEAN RESPIRATORY SOC JOURNALS LTD, ISSN: 0903-1936

Conference paper

Boccabella C, Macaluso C, Kokosi M, Alfieri V, Stock C, Kouranos V, Margaritopoulos G, Mori L, Barnett J, Molyneaux P, George P, Chua F, Maher T, Desai S, Jacob J, Devaraj A, Wells A, Renzoni Eet al., 2018, Pulmonary function trends predict mortality in patients with hypersensitivity pneumonitis, 28th International Congress of the European-Respiratory-Society (ERS), Publisher: EUROPEAN RESPIRATORY SOC JOURNALS LTD, ISSN: 0903-1936

Conference paper

Tavare AN, Hare SS, Miller FNA, Hammond CJ, Edey A, Devaraj Aet al., 2018, A survey of UK percutaneous lung biopsy practice: current practices in the era of early detection, oncogenetic profiling, and targeted treatments, CLINICAL RADIOLOGY, Vol: 73, Pages: 800-809, ISSN: 0009-9260

Journal article

Nair A, Devaraj A, Callister MEJ, Baldwin DRet al., 2018, The Fleischner Society 2017 and British Thoracic Society 2015 guidelines for managing pulmonary nodules: keep calm and carry on, THORAX, Vol: 73, Pages: 806-812, ISSN: 0040-6376

Journal article

Schreuder A, van Ginneken B, Scholten ET, Jacobs C, Prokop M, Sverzellati N, Desai SR, Devaraj A, Schaefer-Prokop CMet al., 2018, Classification of CT Pulmonary Opacities as Perifissural Nodules: Reader Variability, RADIOLOGY, Vol: 288, Pages: 867-875, ISSN: 0033-8419

Journal article

Rogers C, Kent-Bramer J, Devaraj A, Nicholson AG, Molyneaux PL, Wells AU, Saikia S, Maher TM, George PMet al., 2018, Rapidly progressive cystic lung disease, American Journal of Respiratory and Critical Care Medicine, Vol: 198, Pages: 264-264, ISSN: 1073-449X

Journal article

Bax S, Bredy C, Kempny A, Dimopoulos K, Devaraj A, Walsh S, Jacob J, Nair A, Kokosi M, Keir G, Kouranos V, George PM, McCabe C, Wilde M, Wells A, Li W, Wort SJ, Price LCet al., 2018, A stepwise composite echocardiographic score predicts severe pulmonary hypertension in patients with interstitial lung disease (vol 4, 124, 2018), ERJ Open Research, Vol: 4, Pages: 1-1, ISSN: 2312-0541

Journal article

Tavare AN, Devaraj A, Nicholson AG, Patel A, Hare SSet al., 2018, Recurrent Pneumocytoma, Clinical Pulmonary Medicine, Vol: 25, Pages: 152-153, ISSN: 1068-0640

Pneumocytoma is an unusual benign pulmonary epithelial neoplasm. Surgical resection is almost always curative. We present a case of a young female patient who had successfully undergone sublobar resection of pneumocytoma 8 years previously and who presented with a histologically proven recurrence adjacent to the surgical staple line. Our case highlights the potential dangers of nonanatomic resection, including for benign entities.

Journal article

McBrien C, Devaraj A, Nicholson AG, Menzies-Gow Aet al., 2018, Hypoxia and eosinophilia in a patient with difficult asthma, LANCET RESPIRATORY MEDICINE, Vol: 6, Pages: 566-566, ISSN: 2213-2600

Journal article

Bax S, Bredy C, Kempny A, Dimopoulos K, Devaraj A, Walsh S, Jacob J, Nair A, Kokosi M, Keir G, Kouranos V, George PM, McCabe C, Wilde M, Wells A, Li W, Wort SJ, Price LCet al., 2018, A stepwise composite echocardiographic score predicts severe pulmonary hypertension in patients with interstitial lung disease, ERJ Open Research, Vol: 4, ISSN: 2312-0541

European Respiratory Society (ERS) guidelines recommend the assessment of patients with interstitial lung disease (ILD) and severe pulmonary hypertension (PH), as defined by a mean pulmonary artery pressure (mPAP) ≥35 mmHg at right heart catheterisation (RHC). We developed and validated a stepwise echocardiographic score to detect severe PH using the tricuspid regurgitant velocity and right atrial pressure (right ventricular systolic pressure (RVSP)) and additional echocardiographic signs. Consecutive ILD patients with suspected PH underwent RHC between 2005 and 2015. Receiver operating curve analysis tested the ability of components of the score to predict mPAP ≥35 mmHg, and a score devised using a stepwise approach. The score was tested in a contemporaneous validation cohort. The score used "additional PH signs" where RVSP was unavailable, using a bootstrapping technique. Within the derivation cohort (n=210), a score ≥7 predicted severe PH with 89% sensitivity, 71% specificity, positive predictive value 68% and negative predictive value 90%, with similar performance in the validation cohort (n=61) (area under the curve (AUC) 84.8% versus 83.1%, p=0.8). Although RVSP could be estimated in 92% of studies, reducing this to 60% maintained a fair accuracy (AUC 74.4%). This simple stepwise echocardiographic PH score can predict severe PH in patients with ILD.

Journal article

Jacob J, Odink A, Brun AL, Macalusoe C, de Lauretis A, Kokosi M, Devaraj A, Desai S, Renzoni E, Wells AUet al., 2018, Functional associations of pleuroparenchymal fibroelastosis and emphysema with hypersensitivity pneumonitis, RESPIRATORY MEDICINE, Vol: 138, Pages: 95-101, ISSN: 0954-6111

BACKGROUNDPleuroparenchymal fibroelastosis (PPFE) has been described in hypersensitivity pneumonitis (HP) yet its functional implications are unclear. Combined pulmonary fibrosis and emphysema (CPFE) has occasionally been described in never-smokers with HP, but epidemiological data regarding its prevalence is sparse. CTs in a large HP cohort were therefore examined to identify the prevalence and effects of PPFE and emphysema.Methods233 HP patients had CT extents of interstitial lung disease (ILD) and emphysema quantified to the nearest 5%. Lobar percentage pleural involvement of PPFE was quantified on a 4-point categorical scale: 0 = absent, 1 = affecting <10%, 2 = affecting 10–33%, 3 = affecting >33%. Marked PPFE reflected a total lung score of ≥3/18. Results were evaluated against FVC, DLco and mortality.RESULTSMarked PPFE prevalence was 23% whilst 23% of never-smokers had emphysema. Following adjustment for patient age, gender, smoking status, and ILD and emphysema extents, marked PPFE independently linked to reduced baseline FVC (p = 0.0002) and DLco (p = 0.002) and when examined alongside the same covariates, independently linked to worsened survival (p = 0.01).CPFE in HP demonstrated a characteristic functional profile of artificial lung volume preservation and disproportionate DLco reduction. CPFE did not demonstrate a worsened outcome when compared to HP patients without emphysema beyond that explained by CT extents of ILD and emphysema.CONCLUSIONSPPFE is not uncommon in HP, and is independently associated with impaired lung function and increased mortality. Emphysema was identified in 23% of HP never-smokers. CPFE appears not to link to a malignant microvascular phenotype as outcome is explained by ILD and emphysema extents.

Journal article

Proli C, De Sousa P, Jordan S, Anikin V, Devaraj A, Love SM, Shackcloth M, Kostoulas N, Papagiannopoulos K, Haqzad Y, Loubani M, Sellitri F, Granato F, Bush A, Marchbank A, Iyer S, Scarci M, Lim E, UK Thoracic Surgery Research Collaborativeet al., 2018, A diagnostic cohort study on the accuracy of 18-fluorodeoxyglucose (18FDG) positron emission tomography (PET)-CT for evaluation of malignancy in anterior mediastinal lesions: the DECiMaL study., BMJ Open, Vol: 8, ISSN: 2044-6055

OBJECTIVES: The aim of this study is to collate multi-institutional data to determine the value by defining the diagnostic performance of fluorodeoxyglucose positron emission tomography (FDG PET)/CT for malignancy in patients undergoing surgery with an anterior mediastinal mass in order to ascertain the clinical utility of PET/CT to differentiate malignant from benign aetiologies in patients presenting with an anterior mediastinal mass SETTING: DECiMaL Study is a multicentre, retrospective, collaborative cohort study in seven UK surgical sites. PARTICIPANTS: Between January 2002 and June 2015, a total of 134 patients were submitted with a mean age (SD) of 55 years (16) of which 69 (51%) were men. We included all patients undergoing surgery who presented with an anterior mediastinal mass and underwent PET/CT. PET/CT was considered positive for any reported avidity as stated in the official report and the reference was the resected specimen reported by histopathology using WHO criteria. PRIMARY AND SECONDARY OUTCOME MEASURES: Sensitivity, specificity, positive and negative predicted values of [18F]-FDG PET in determining malignant aetiology for an anterior mediastinal mass. RESULTS: The sensitivity and specificity of PET/CT to correctly classify malignant disease were 83% (95% CI 74 to 89) and 58% (95% CI 37 to 78). The positive and negative predictive values were 90% (95% CI 83% to 95%) and 42% (95% CI 26% to 61%). CONCLUSIONS: The results of our study suggest reasonable sensitivity but no specificity implying that a negative PET/CT is useful to rule out the diagnosis of malignant disease whereas a positive result has no value in the discrimination between malignant and benign diseases of the anterior mediastinum.

Journal article

Sheard S, Moser J, Sayer C, Stefanidis K, Devaraj A, Vlahos Iet al., 2018, Lung Cancers Associated with Cystic Airspaces: Underrecognized Features of Early Disease, RADIOGRAPHICS, Vol: 38, Pages: 704-717, ISSN: 0271-5333

Journal article

Field JK, Heuvelmans MA, Devaraj A, Heussel CP, Baldwin DR, Vliegenthart R, Duffy SW, Oudkerk Met al., 2018, Low-dose CT for lung cancer screening Reply, LANCET ONCOLOGY, Vol: 19, Pages: E135-E136, ISSN: 1470-2045

Journal article

Veiga C, Landau D, McClelland JR, Ledermann JA, Hawkes D, Janes SM, Devaraj Aet al., 2018, Long term radiological features of radiation-induced lung damage, RADIOTHERAPY AND ONCOLOGY, Vol: 126, Pages: 300-306, ISSN: 0167-8140

Journal article

Jacob J, Song JW, Yoon H-Y, Cross G, Barnett J, Woo WL, Adams F, Kokosi M, Devaraj A, Renzoni E, Maher TM, Kim DS, Wells AUet al., 2018, Prevalence and effects of emphysema in never-smokers with rheumatoid arthritis interstitial lung disease, EBioMedicine, Vol: 28, Pages: 303-310, ISSN: 2352-3964

AIMS: Autoimmune conditions such as rheumatoid arthritis-related interstitial lung disease (RA-ILD) have been linked to the existence of emphysema in never-smokers. We aimed to quantify emphysema prevalence in RA-ILD never-smokers and investigate whether combined pulmonary fibrosis and emphysema (CPFE) results in a worsened prognosis independent of baseline disease extent. METHODS: RA-ILD patients presenting to the Royal Brompton Hospital (n=90) and Asan Medical Center (n=155) had CT's evaluated for a definite usual interstitial pneumonia (UIP) pattern, and visual extents of emphysema and ILD. RESULTS: Emphysema, identified in 31/116 (27%) RA-ILD never-smokers, was associated with obstructive functional indices and conformed to a CPFE phenotype: disproportionate reduction in gas transfer (DLco), relative preservation of lung volumes. Using multivariate logistic regression, adjusted for patient age, gender and ILD extent, emphysema presence independently associated with a CT-UIP pattern in never-smokers (0.009) and smokers (0.02). On multivariate Cox analysis, following adjustment for patient age, gender, DLco, and a CT-UIP pattern, emphysema presence (representing the CPFE phenotype) independently associated with mortality in never-smokers (p=0.04) and smokers (p<0.05). CONCLUSION: 27% of RA-ILD never-smokers demonstrate emphysema on CT. Emphysema presence in never-smokers independently associates with a definite CT-UIP pattern and a worsened outcome following adjustment for baseline disease severity.

Journal article

Nair A, Screaton NJ, Holemans JA, Jones D, Clements L, Barton B, Gartland N, Duffy SW, Baldwin DR, Field JK, Hansell DM, Devaraj Aet al., 2018, The impact of trained radiographers as concurrent readers on performance and reading time of experienced radiologists in the UK Lung Cancer Screening (UKLS) trial, EUROPEAN RADIOLOGY, Vol: 28, Pages: 226-234, ISSN: 0938-7994

Journal article

Field JK, Baldwin DR, Devaraj A, Oudkerk Met al., 2018, THE ROLE OF IMAGING IN SCREENING SPECIAL FEATURE: COMMENTARY EUPS-argues that lung cancer screening should be implemented in 18 months, BRITISH JOURNAL OF RADIOLOGY, Vol: 91, ISSN: 0007-1285

Journal article

Shah A, Abdolrasouli A, Schelenz S, Thornton C, Ni MZ, Devaraj A, Devic N, Ward L, Carby M, Reed A, Costelloe C, Armstrong-James Det al., 2017, Latent class modelling for pulmonary aspergillosis diagnosis in lung transplant recipients, Winter Meeting of the British-Thoracic-Society, Publisher: BMJ PUBLISHING GROUP, Pages: A13-A14, ISSN: 0040-6376

Rationale Timely, accurate diagnosis of invasive aspergillosis (IA) is key to enable initiation of antifungal therapy in lung transplantation. Despite promising novel fungal biomarkers, the lack of a diagnostic gold-standard creates difficulty in determining utility.Objectives This study aimed to use latent class modelling of fungal diagnostics to classify lung transplant recipients (LTR) with IA in a large single centre.Methods Regression models were used to compare composite biomarker testing of bronchoalveolar lavage to clinical and EORTC-MSG guideline-based diagnosis of IA with mortality used as a surrogate primary outcome measure. Bootstrap analysis identified radiological features associated with IA. Bayesian latent class modelling was used to define IA.Measurements and Main Results A clinical diagnosis of fungal infection (P =<0.001) and composite biomarker positive Results (P =<0.001) had significantly increased 12 month mortality. There was poor correlation between clinical diagnosis, EORTC-based IA diagnosis and composite biomarker positivity. Tracheobronchitis was positively predictive of a clinical and composite biomarker positive diagnosis of IA (p=0.004;95% CI–1.79–21.28 and p=0.03;95% CI–0.85–15.62 respectively). Latent class modelling resulted in the formation of 3 groups: Class 1: likely fungal infection; Class 2: unlikely fungal infection; Class 3: unclassifiable. A. fumigatus PCR was positive in ∼90% of class 1 LTRs compared to only 1% in class 2. Analysis of mortality showed a trend towards significance comparing class 1 with class 2 (p=0.06;HR–4.7;95% CI(0.91–24)) (figure 1).

Conference paper

Bax SRB, Breedy C, Dimopoulos K, Kempny A, Devaraj A, Walsh S, Joseph J, Nair A, Kier G, Kokosi M, Harries C, Kouranos V, McCabe C, Li W, Wilde M, Wells AU, Price LC, Wort SJet al., 2017, DERIVATION AND VALIDATION OF A SIMPLE LONGITUDINAL SCORE WHICH STRONGLY PREDICTS MORTALITY IN INTERSTITIAL LUNG DISEASE (ILD) ASSOCIATED PULMONARY HYPERTENSION (ILD-PH), Winter Meeting of the British-Thoracic-Society, Publisher: BMJ PUBLISHING GROUP, Pages: A35-A36, ISSN: 0040-6376

Conference paper

Bax SRB, Breedy C, Dimopoulos K, Kempny A, Devaraj A, Walsh S, Joseph J, Nair S, Kokosi M, Kier G, Harries C, Kouranos V, McCabe C, Li W, Wilde M, Wells AU, Price LC, Wort SJet al., 2017, PULMONARY VASCULAR DISEASE MARKERS PREDICT DEATH IN INTERSTITIAL LUNG DISEASE PATIENTS PROVEN NOT TO HAVE PULMONARY HYPERTENSION AT RIGHT HEART CATHETER, Winter Meeting of the British-Thoracic-Society, Publisher: BMJ PUBLISHING GROUP, Pages: A168-A169, ISSN: 0040-6376

Conference paper

Ruparel M, Dickson JL, Quaife SL, Bhowmik A, Taylor MN, Ahmed A, Shaw PJ, Burke S, Soo MJ, Devaraj A, Navani N, Duffy SW, Baldwin DR, Waller J, Janes SMet al., 2017, LUNG CANCER RISK PROFILES AND ELIGIBILITY OF ATTENDEES IN A LUNG CANCER SCREENING DEMONSTRATION PILOT, Winter Meeting of the British-Thoracic-Society, Publisher: BMJ PUBLISHING GROUP, Pages: A11-A12, ISSN: 0040-6376

Conference paper

Ruparel M, Quaife SL, Dickson JL, Bhowmik A, Taylor MN, Ahmed A, Shaw PJ, Burke S, Soo MJ, Devaraj A, Navani N, Duffy SW, Baldwin DR, Waller J, Janes SMet al., 2017, IDENTIFICATION AND ATTENDANCE OF A HIGH-RISK COHORT IN A LUNG CANCER SCREENING DEMONSTRATION PILOT, Winter Meeting of the British-Thoracic-Society, Publisher: BMJ PUBLISHING GROUP, Pages: A10-A10, ISSN: 0040-6376

Conference paper

Oudkerk M, Devaraj A, Vliegenthart R, Henzler T, Prosch H, Heussel CP, Bastarrika G, Sverzellati N, Mascalchi M, Delorme S, Baldwin DR, Callister ME, Becker N, Heuvelmans MA, Rzyman W, Infante MV, Pastorino U, Pedersen JH, Paci E, Duffy SW, de Koning H, Field JKet al., 2017, European position statement on lung cancer screening, LANCET ONCOLOGY, Vol: 18, Pages: E754-E766, ISSN: 1470-2045

Journal article

Woznitza N, Devaraj A, Janes SM, Duffy SW, Bhowmik A, Rowe S, Piper K, Maughn S, Baldwin DRet al., 2017, Impact of radiographer immediate reporting of chest X-rays from general practice on the lung cancer pathway (radioX): study protocol for a randomised control trial., Trials, Vol: 18, ISSN: 1745-6215

BACKGROUND: Diagnostic capacity and suboptimal logistics are consistently identified as barriers to timely diagnosis of cancer, especially lung cancer. Immediate chest X-ray (CXR) reporting for patients referred from general practice is advocated in the National Optimal Lung Cancer Pathway to improve time to diagnosis of lung cancer and to reduce inappropriate urgent respiratory medicine referral for suspected cancer (2WW) referrals. The aim of radioX is to examine the impact of immediate reporting by radiographers of CXRs requested by general practice (GP) on lung cancer patient pathways. METHODS: A two-way comparative study that will compare the time to diagnosis of lung cancer for patients. Internal comparison will be made between those who receive an immediate radiographer report of a GP CXR compared to standard radiographer GP CXR reporting over a 12-month period. External comparison will be made with a similar, neighbouring hospital trust that does not have radiographer CXR reporting. Primary outcome is the effect on the speed of the lung cancer pathway (diagnosis of cancer or discharge). Secondary outcomes include the effect of the pathway on efficiency including the number of repeat CXRs performed in a timely fashion for suspected infection and the effect of immediate reporting of GP CXRs on patient satisfaction. DISCUSSION: The radioX trial will examine the hypothesis that immediate reporting of CXRs referred from GP reduces the time to diagnosis of lung cancer or discharge from the lung cancer pathway. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number ISRCTN21818068 . Registered on 20 June 2017.

Journal article

Veiga C, Landau D, Devaraj A, Doel T, Hawkes D, Mcclelland Jet al., 2017, Toward a Radiological Scoring System of Radiotherapy-Induced Lung Damage, Publisher: ELSEVIER SCIENCE INC, Pages: S1838-S1838, ISSN: 1556-0864

Conference paper

Veiga C, Landau D, Devaraj A, Doel T, Hawkes D, McClelland Jet al., 2017, Quantification of Radiation Therapy-Induced Diaphragmatic Changes Using Serial CT Imaging, 59th Annual Meeting of the American-Society-for-Therapeutic-Radiation-Oncology (ASTRO), Publisher: ELSEVIER SCIENCE INC, Pages: S12-S12, ISSN: 0360-3016

Conference paper

Brain K, Carter B, Lifford KJ, Burke O, Devaraj A, Baldwin DR, Duffy S, Field JKet al., 2017, Impact of low-dose CT screening on smoking cessation among high-risk participants in the UK Lung Cancer Screening Trial, THORAX, Vol: 72, Pages: 912-918, ISSN: 0040-6376

Background Smoking cessation was examined among high-risk participants in the UK Lung Cancer Screening (UKLS) Pilot Trial of low-dose CT screening.Methods High-risk individuals aged 50–75 years who completed baseline questionnaires were randomised to CT screening (intervention) or usual care (no screening control). Smoking habit was determined at baseline using self-report. Smokers were asked whether they had quit smoking since joining UKLS at T1 (2 weeks after baseline scan results or control assignment) and T2 (up to 2 years after recruitment). Intention-to-treat (ITT) regression analyses were undertaken, adjusting for baseline lung cancer distress, trial site and sociodemographic variables.Results Of a total 4055 individuals randomised to CT screening or control, 1546 were baseline smokers (759 intervention, 787 control). Smoking cessation rates were 8% (control n=36/479) versus 14% (intervention n=75/527) at T1 and 21% (control n=79/377) versus 24% (intervention n=115/488) at T2. ITT analyses indicated that the odds of quitting among screened participants were significantly higher at T1 (adjusted OR (aOR) 2.38, 95% CI 1.56 to 3.64, p<0.001) and T2 (aOR 1.60, 95% CI 1.17 to 2.18, p=0.003) compared with control. Intervention participants who needed additional clinical investigation were more likely to quit in the longer term compared with the control group (aOR 2.29, 95% CI 1.62 to 3.22, p=0.007) and those receiving a negative result (aOR 2.43, 95% CI 1.54 to 3.84, p<0.001).Conclusions CT lung cancer screening for high-risk participants presents a teachable moment for smoking cessation, especially among those who receive a positive scan result. Further behavioural research is needed to evaluate optimal strategies for integrating smoking cessation intervention with stratified lung cancer screening.

Journal article

Robbie H, Daccord C, Chua F, Devaraj Aet al., 2017, Evaluating disease severity in idiopathic pulmonary fibrosis., European Respiratory Review, Vol: 26, ISSN: 0905-9180

Accurate assessment of idiopathic pulmonary fibrosis (IPF) disease severity is integral to the care provided to patients with IPF. However, to date, there are no generally accepted or validated staging systems. There is an abundance of data on using information acquired from physiological, radiological and pathological parameters, in isolation or in combination, to assess disease severity in IPF. Recently, there has been interest in using serum biomarkers and computed tomography-derived quantitative lung fibrosis measures to stage disease severity in IPF. This review will focus on the suggested methods for staging IPF, at baseline and on serial assessment, their strengths and limitations, as well as future developments.

Journal article

Flaherty KR, Brown KK, Wells AU, Clerisme-Beaty E, Collard HR, Cottin V, Devaraj A, Inoue Y, Le Maulf F, Richeldi L, Schmidt H, Walsh S, Mezzanotte W, Schlenker-Herceg Ret al., 2017, Design of the PF-ILD trial: a double-blind, randomised, placebo-controlled phase III trial of nintedanib in patients with progressive fibrosing interstitial lung disease., BMJ Open Respiratory Research, Vol: 4, ISSN: 2052-4439

600 patients aged ≥18 years will be randomised in a 1:1 ratio to nintedanib or placebo. Patients with diagnosis of IPF will be excluded. The study population will be enriched with two-thirds having a usual interstitial pneumonia-like pattern on HRCT. The primary endpoint is the annual rate of decline in forced vital capacity over 52 weeks. The main secondary endpoints are the absolute change from baseline in King's Brief Interstitial Lung Disease Questionnaire total score, time to first acute interstitial lung disease exacerbation or death and time to all-cause mortality over 52 weeks. ETHICS AND DISSEMINATION: The trial is conducted in accordance with the Declaration of Helsinki, the International Conference on Harmonisation Tripartite Guideline for Good Clinical Practice (GCP) and Japanese GCP regulations. TRIAL REGISTRATION NUMBER: NCT02999178.

Journal article

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