Severe Prospective Observational COPD Catalonia

Официальное название

Severe Prospective Observational Study of COPD in Catalonia

Обзор

Multicenter observational study to characterize and follow-up a cohort of patients with severe chronic obstructive pulmonary disease (COPD) in Catalonia

Подробное описание

Creation of the first multicenter observational study in Catalonia to characterize and follow-up of patients with severe chronic obstructive pulmonary disease. The follow-up will be up to 5 years, with a first initial visit and control visits every year. All patients will be recruited from respiratory departments from major hospitals from Catalonia, a region with approximately 8 million inhabitants and a wide web of public hospitals.

Первичные конечные точки

• Cohort creation in Catalonia [Срок оценки: Up to 5 years]
• Describe the demographic and clinical characteristics of patients with severe COPD in Catalonia. [Срок оценки: Up to 5 years]
• Assess the natural history and prognosis of severe COPD [Срок оценки: Up to 5 years]

Вторичные конечные точки (3)

• Assess effect of the different treatments, both inhaled and non-inhaled, on the disease progression and according to the patient's phenotype. [Срок оценки: Up to 5 years]
• Impact of exacerbations and chronic bronchial infection on the evolution of COPD [Срок оценки: Up to 5 years]
• Importance of comorbidities in the evolution of COPD [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

• Informed consent: a signed and dated written informed consent prior to study participation
• Age: Subjects 35 years of age or order at visit 1.
• Severe COPD diagnosis: an established severe COPD defined by spirometry values:

• A post-albuterol/salbutamol FEV1/FVC ratio of <0.70 at visit 1. FEV1: forced expiratory volume at one second FVC: forced vital capacity.
• A post-bronchodilator FEV1 < 50% predicted normal
• Smoking history: ≥ 10 pack-years at visit 1
• Stable phase of the disease (not less than 4 weeks of stability prior visit 1)

Критерии исключения

• Subjects not giving written informed consent.
• Subjects at risk of non-compliance, or unable to comply with the scheduled visits.
• Subjects affected mainly by another severe chronic respiratory disease that justifies the ventilatory alteration, for example pulmonary fibrosis or severe bronchiectasis
• Subjects with carcinoma that has not been in complete remission for at least 5 years.
• Subjects with α1-antitrypsin deficiency as the underlying cause of COPD

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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. doi: 10.1056/NEJMoa021322. PMID 14999112
• Almagro P, Soriano JB, Cabrera FJ, Boixeda R, Alonso-Ortiz MB, Barreiro B, Diez-Manglano J, Murio C, Heredia JL; Working Group on COPD, SpanishSociety of Internal Medicine*. Short- and medium-term prognosis in patients hospitalized for COPD exacerbation: the CODEX index. Chest. 2014 May;145(5):972-980. doi: 10.1378/chest.13-1328. PMID 24077342
• Fletcher C, Peto R. The natural history of chronic airflow obstruction. Br Med J. 1977 Jun 25;1(6077):1645-8. doi: 10.1136/bmj.1.6077.1645. PMID 871704
• Lokke A, Lange P, Scharling H, Fabricius P, Vestbo J. Developing COPD: a 25 year follow up study of the general population. Thorax. 2006 Nov;61(11):935-9. doi: 10.1136/thx.2006.062802. PMID 17071833
• Kohansal R, Martinez-Camblor P, Agusti A, Buist AS, Mannino DM, Soriano JB. The natural history of chronic airflow obstruction revisited: an analysis of the Framingham offspring cohort. Am J Respir Crit Care Med. 2009 Jul 1;180(1):3-10. doi: 10.1164/rccm.200901-0047OC. Epub 2009 Apr 2. PMID 19342411
• Vestbo J, Anderson W, Coxson HO, Crim C, Dawber F, Edwards L, Hagan G, Knobil K, Lomas DA, MacNee W, Silverman EK, Tal-Singer R; ECLIPSE investigators. Evaluation of COPD Longitudinally to Identify Predictive Surrogate End-points (ECLIPSE). Eur Respir J. 2008 Apr;31(4):869-73. doi: 10.1183/09031936.00111707. Epub 2008 Jan 23. PMID 18216052
• Garcia-Aymerich J, Gomez FP, Anto JM; en nombre del Grupo Investigador del Estudio PAC-COPD. [Phenotypic characterization and course of chronic obstructive pulmonary disease in the PAC-COPD Study: design and methods]. Arch Bronconeumol. 2009 Jan;45(1):4-11. doi: 10.1016/j.arbres.2008.03.001. Epub 2009 Jan 3. Spanish. PMID 19186292
• Regan EA, Hokanson JE, Murphy JR, Make B, Lynch DA, Beaty TH, Curran-Everett D, Silverman EK, Crapo JD. Genetic epidemiology of COPD (COPDGene) study design. COPD. 2010 Feb;7(1):32-43. doi: 10.3109/15412550903499522. PMID 20214461

Идентификаторы

NCT: NCT06252805 · FUC-SPOCCAT-2023-10

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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