Chronic Obstructive Pulmonary Disease Clinical Trial
— CASCADEOfficial title:
A Quantitative Study in Early Chronic Obstructive Pulmonary Disease, Using a Cluster Analysis, to Establish if Prospective, Individualised, Medical Intervention Alters Projected Clinical Course
NCT number | NCT02882165 |
Other study ID # | 23464 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | July 2015 |
Est. completion date | February 2017 |
Verified date | June 2021 |
Source | University of Southampton |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Chronic Obstructive Pulmonary Disease (COPD) is a condition resulting from environmentally induced lung damage e.g. cigarette smoking and air pollution which, over time, causes individuals to suffer from symptoms including chronic cough and progressive breathlessness. In the UK COPD is predominantly caused by cigarette smoking which may have occurred decades before the symptoms appear and the disease is diagnosed. The aim of this study is to identify those COPD patients who currently have milder disease and to investigate whether a detailed, medical assessment which has time to assess all aspects of their care will improve their lung health and general wellbeing. COPD is a major cause of disability and death in the UK, with around 835,000 people currently diagnosed with the disease and an estimated further two million people who suffer from symptoms but do not yet have a diagnosis(1). Approximately 25,000 people each year die from COPD in England and Wales (2), with the disease accounting for 5.4% of all deaths in England and Wales in 2013 (3). Predominantly in its later, more severe stages, COPD causes an enormous symptom burden to patients, and accounts for up to half of emergency admissions to already overstretched hospital services in England (4). People with COPD, with a past history of smoking, are at higher risk of other medical problems such as heart disease and stroke(5). Being breathless and having multiple physical health problems can also lead to mental health problems such as anxiety and depression(5). This means it can be challenging to provide this group of people enough time to fully assess and treat all their problems, particularly due to current pressure on the length of GP appointment times. Whilst COPD is treatable, it is not curable, and emphasis on early diagnosis and intervention provided a key part of the strategy for COPD published by NHS England in 2012(6). With early diagnosis, the opportunity is provided to intervene with the aim of improving symptoms and exercise tolerance, reducing the risk of exacerbations, slowing deterioration and prolonging quality of life.
Status | Completed |
Enrollment | 116 |
Est. completion date | February 2017 |
Est. primary completion date | October 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Already on primary care COPD register and DOSE score <4 (low risk) Exclusion Criteria: - No capacity to consent or unable to travel to primary care practice (local GP surgery) |
Country | Name | City | State |
---|---|---|---|
United Kingdom | NIHR Wessex CLAHRC-Theme 1 | Southampton | Hampshire |
Lead Sponsor | Collaborator |
---|---|
University of Southampton | Collaboration for Leadership in Applied Health Research and Care (CLAHRC), UK, National Institute for Health Research, United Kingdom |
United Kingdom,
British Thoracic Society. The Burden of Lung Disease, Statistics Report. British Thoracic Society, 2006
Cavaillès A, Brinchault-Rabin G, Dixmier A, Goupil F, Gut-Gobert C, Marchand-Adam S, Meurice JC, Morel H, Person-Tacnet C, Leroyer C, Diot P. Comorbidities of COPD. Eur Respir Rev. 2013 Dec;22(130):454-75. doi: 10.1183/09059180.00008612. Review. — View Citation
Celli BR, Cote CG, Marin JM, Casanova C, Montes de Oca M, Mendez RA, Pinto Plata V, Cabral HJ. The body-mass index, airflow obstruction, dyspnea, and exercise capacity index in chronic obstructive pulmonary disease. N Engl J Med. 2004 Mar 4;350(10):1005-12. — View Citation
Csikesz NG, Gartman EJ. New developments in the assessment of COPD: early diagnosis is key. Int J Chron Obstruct Pulmon Dis. 2014 Feb 27;9:277-86. doi: 10.2147/COPD.S46198. eCollection 2014. Review. — View Citation
Fletcher CM. Prognosis in chronic bronchitis. Aspen Emphysema Conf. 1968;9:309-15. — View Citation
Jones RC, Donaldson GC, Chavannes NH, Kida K, Dickson-Spillmann M, Harding S, Wedzicha JA, Price D, Hyland ME. Derivation and validation of a composite index of severity in chronic obstructive pulmonary disease: the DOSE Index. Am J Respir Crit Care Med. 2009 Dec 15;180(12):1189-95. doi: 10.1164/rccm.200902-0271OC. Epub 2009 Sep 24. — View Citation
Lacasse Y, Cates CJ, McCarthy B, Welsh EJ. This Cochrane Review is closed: deciding what constitutes enough research and where next for pulmonary rehabilitation in COPD. Cochrane Database Syst Rev. 2015 Nov 18;(11):ED000107. doi: 10.1002/14651858.ED000107. — View Citation
Motegi T, Jones RC, Ishii T, Hattori K, Kusunoki Y, Furutate R, Yamada K, Gemma A, Kida K. A comparison of three multidimensional indices of COPD severity as predictors of future exacerbations. Int J Chron Obstruct Pulmon Dis. 2013;8:259-71. doi: 10.2147/COPD.S42769. Epub 2013 May 31. — View Citation
NHS England. An Outcomes Strategy for COPD and Asthma: NHS Companion Document. Department of Health 2012
Office for National Statistics. Death Registrations Summary Tables, England and Wales, 2013
Office for National Statistics. Mortality Statistics: Deaths Registered in England and Wales (Series DR), 2013
Petty TL. The history of COPD. Int J Chron Obstruct Pulmon Dis. 2006;1(1):3-14. Review. — View Citation
Rabe KF, Hurd S, Anzueto A, Barnes PJ, Buist SA, Calverley P, Fukuchi Y, Jenkins C, Rodriguez-Roisin R, van Weel C, Zielinski J; Global Initiative for Chronic Obstructive Lung Disease. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2007 Sep 15;176(6):532-55. Epub 2007 May 16. Review. — View Citation
Rolink M, van Dijk W, van den Haak-Rongen S, Pieters W, Schermer T, van den Bemt L. Using the DOSE index to predict changes in health status of patients with COPD: a prospective cohort study. Prim Care Respir J. 2013 Jun;22(2):169-74. doi: 10.4104/pcrj.2013.00033. — View Citation
Sin DD, Anthonisen NR, Soriano JB, Agusti AG. Mortality in COPD: Role of comorbidities. Eur Respir J. 2006 Dec;28(6):1245-57. Review. — View Citation
Soler-Cataluña JJ, Martínez-García MA, Román Sánchez P, Salcedo E, Navarro M, Ochando R. Severe acute exacerbations and mortality in patients with chronic obstructive pulmonary disease. Thorax. 2005 Nov;60(11):925-31. Epub 2005 Jul 29. — View Citation
Soler-Cataluña JJ, Martínez-García MA, Sánchez LS, Tordera MP, Sánchez PR. Severe exacerbations and BODE index: two independent risk factors for death in male COPD patients. Respir Med. 2009 May;103(5):692-9. doi: 10.1016/j.rmed.2008.12.005. Epub 2009 Jan 7. — View Citation
Sundh J, Janson C, Lisspers K, Ställberg B, Montgomery S. The Dyspnoea, Obstruction, Smoking, Exacerbation (DOSE) index is predictive of mortality in COPD. Prim Care Respir J. 2012 Sep;21(3):295-301. doi: 10.4104/pcrj.2012.00054. — View Citation
Tantucci C, Modina D. Lung function decline in COPD. Int J Chron Obstruct Pulmon Dis. 2012;7:95-9. doi: 10.2147/COPD.S27480. Epub 2012 Feb 9. Review. — View Citation
Tiong LU, Davies R, Gibson PG, Hensley MJ, Hepworth R, Lasserson TJ, Smith B. Lung volume reduction surgery for diffuse emphysema. Cochrane Database Syst Rev. 2006 Oct 18;(4):CD001001. Review. Update in: Cochrane Database Syst Rev. 2016 Oct 14;10 :CD001001. — View Citation
* Note: There are 20 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | COPD Assessment Test (CAT) score | Validated measure of COPD symptom impact | 12 months | |
Secondary | GAD-7 score | Validated measure of symptoms of anxiety impact on life | 12 months | |
Secondary | PHQ-9 score | Validated measure of symptoms of depression impact on life | 12 months | |
Secondary | EQ5D score | Validated measure of quality of life | 12 months |
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