Severe Prospective Observational COPD Catalonia

NCT ID: NCT06252805

Last Updated: 2024-02-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-10

Study Completion Date

2030-03-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Severe Chronic Obstructive Pulmonary Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SPOCCAT

Severe Chronic Obstructive Pulmonary Disease patients in Catalonia

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* 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)

Exclusion Criteria

* 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
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ferran Morell

OTHER

Sponsor Role lead

Responsible Party

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Ferran Morell

president

Responsibility Role SPONSOR_INVESTIGATOR

References

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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.

Reference Type BACKGROUND
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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.

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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.

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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.

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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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
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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.

Reference Type BACKGROUND
PMID: 20214461 (View on PubMed)

Makita H, Nasuhara Y, Nagai K, Ito Y, Hasegawa M, Betsuyaku T, Onodera Y, Hizawa N, Nishimura M; Hokkaido COPD Cohort Study Group. Characterisation of phenotypes based on severity of emphysema in chronic obstructive pulmonary disease. Thorax. 2007 Nov;62(11):932-7. doi: 10.1136/thx.2006.072777. Epub 2007 Jun 15.

Reference Type BACKGROUND
PMID: 17573447 (View on PubMed)

Kunzli N, Ackermann-Liebrich U, Keller R, Perruchoud AP, Schindler C. Variability of FVC and FEV1 due to technician, team, device and subject in an eight centre study: three quality control studies in SAPALDIA. Swiss Study on Air Pollution and Lung Disease in Adults. Eur Respir J. 1995 Mar;8(3):371-6. doi: 10.1183/09031936.95.08030371.

Reference Type BACKGROUND
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Downs SH, Brandli O, Zellweger JP, Schindler C, Kunzli N, Gerbase MW, Burdet L, Bettschart R, Zemp E, Frey M, Keller R, Tschopp JM, Leuenberger P, Ackermann-Liebrich U; SAPALDIA team. Accelerated decline in lung function in smoking women with airway obstruction: SAPALDIA 2 cohort study. Respir Res. 2005 May 26;6(1):45. doi: 10.1186/1465-9921-6-45.

Reference Type BACKGROUND
PMID: 15918902 (View on PubMed)

Lopez-Campos JL, Peces-Barba G, Soler-Cataluna JJ, Soriano JB, de Lucas Ramos P, de-Torres JP, Marin JM, Casanova C; en nombre del grupo de estudio CHAIN. Chronic obstructive pulmonary disease history assessment in Spain: a multidimensional chronic obstructive pulmonary disease evaluation. Study methods and organization. Arch Bronconeumol. 2012 Dec;48(12):453-9. doi: 10.1016/j.arbres.2012.05.006. Epub 2012 Jul 4. English, Spanish.

Reference Type BACKGROUND
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Calle Rubio M, Rodriguez Hermosa JL, de Torres JP, Marin JM, Martinez-Gonzalez C, Fuster A, Cosio BG, Peces-Barba G, Solanes I, Feu-Collado N, Lopez-Campos JL, Casanova C; CHAIN Study Investigators. COPD Clinical Control: predictors and long-term follow-up of the CHAIN cohort. Respir Res. 2021 Feb 4;22(1):36. doi: 10.1186/s12931-021-01633-y.

Reference Type BACKGROUND
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Chen CZ, Shih CY, Hsiue TR, Tsai SH, Liao XM, Yu CH, Yang SC, Wang JD. Life expectancy (LE) and loss-of-LE for patients with chronic obstructive pulmonary disease. Respir Med. 2020 Oct;172:106132. doi: 10.1016/j.rmed.2020.106132. Epub 2020 Aug 29.

Reference Type BACKGROUND
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Soriano JB, Alfageme I, Miravitlles M, de Lucas P, Soler-Cataluna JJ, Garcia-Rio F, Casanova C, Rodriguez Gonzalez-Moro JM, Cosio BG, Sanchez G, Ancochea J. Prevalence and Determinants of COPD in Spain: EPISCAN II. Arch Bronconeumol (Engl Ed). 2021 Jan;57(1):61-69. doi: 10.1016/j.arbres.2020.07.024. Epub 2020 Sep 17. English, Spanish.

Reference Type RESULT
PMID: 32950310 (View on PubMed)

Related Links

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https://goldcopd.org/2023-gold-report-2

GOLD COPD 2023 report (GOLD: Global Initiative for Chronical Obstructive Lung Disease)

https://www.who.int/news-room/fact-sheets/detail/the-top-10-causes-of-death

WHO (World Health Organization). The Top 10 causes ofr death

Other Identifiers

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FUC-SPOCCAT-2023-10

Identifier Type: -

Identifier Source: org_study_id

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