Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Influence of Electronic Cigarettes in the Evaluation of the Inflammatory Response in Patients With a Diagnosis of COPD
NCT number | NCT02892396 |
Other study ID # | STUDY ECIGPOC |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | October 1, 2016 |
Est. completion date | March 2019 |
Verified date | February 2020 |
Source | Fundacio Catalana de Pneumologia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This study evaluates the local and systemic inflammatory response in the airway in COPD patients who consume electronic cigarettes compared with conventional cigarette smokers.
Status | Completed |
Enrollment | 10 |
Est. completion date | March 2019 |
Est. primary completion date | August 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Male |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - COPD patients Gold B or C - Regular smokers with no desire to quit their habit. Exclusion Criteria: - Severe cardiovascular diseases. - Chronic inflammatory diseases. - Active oncologic diseases. - Treatment with corticosteroids or other antiinflammatory drugs. - Acute exacerbation of COPD in the last 12 weeks previous to their inclusion in the study |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clinic | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Fundacio Catalana de Pneumologia |
Spain,
Abrams DB. Promise and peril of e-cigarettes: can disruptive technology make cigarettes obsolete? JAMA. 2014 Jan 8;311(2):135-6. doi: 10.1001/jama.2013.285347. — View Citation
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Anthonisen NR, Skeans MA, Wise RA, Manfreda J, Kanner RE, Connett JE; Lung Health Study Research Group. The effects of a smoking cessation intervention on 14.5-year mortality: a randomized clinical trial. Ann Intern Med. 2005 Feb 15;142(4):233-9. — View Citation
Caponnetto P, Campagna D, Cibella F, Morjaria JB, Caruso M, Russo C, Polosa R. EffiCiency and Safety of an eLectronic cigAreTte (ECLAT) as tobacco cigarettes substitute: a prospective 12-month randomized control design study. PLoS One. 2013 Jun 24;8(6):e66317. doi: 10.1371/journal.pone.0066317. Print 2013. Erratum in: PLoS One. 2014;9(1). doi:10.1371/annotation/e12c22d3-a42b-455d-9100-6c7ee45d58d0. — View Citation
Fairchild AL, Bayer R, Colgrove J. The renormalization of smoking? E-cigarettes and the tobacco "endgame". N Engl J Med. 2014 Jan 23;370(4):293-5. doi: 10.1056/NEJMp1313940. Epub 2013 Dec 18. Erratum in: N Engl J Med. 2014 Jun 12;370(24):2354. — View Citation
Hureaux J, Drouet M, Urban T. A case report of subacute bronchial toxicity induced by an electronic cigarette. Thorax. 2014 Jun;69(6):596-7. doi: 10.1136/thoraxjnl-2013-204767. Epub 2014 Jan 16. — View Citation
McDonald VM, Higgins I, Wood LG, Gibson PG. Multidimensional assessment and tailored interventions for COPD: respiratory utopia or common sense? Thorax. 2013 Jul;68(7):691-4. doi: 10.1136/thoraxjnl-2012-202646. Epub 2013 Mar 16. Review. — View Citation
Miravitlles M, Soriano JB, García-Río F, Muñoz L, Duran-Tauleria E, Sanchez G, Sobradillo V, Ancochea J. Prevalence of COPD in Spain: impact of undiagnosed COPD on quality of life and daily life activities. Thorax. 2009 Oct;64(10):863-8. doi: 10.1136/thx.2009.115725. Epub 2009 Jun 23. — View Citation
Murray CJ, Lopez AD. Alternative projections of mortality and disability by cause 1990-2020: Global Burden of Disease Study. Lancet. 1997 May 24;349(9064):1498-504. — View Citation
Sobradillo V, Miravitlles M, Jiménez CA, Gabriel R, Viejo JL, Masa JF, Fernández-Fau L, Villasante C. [Epidemiological study of chronic obstructive pulmonary disease in Spain (IBERPOC): prevalence of chronic respiratory symptoms and airflow limitation]. Arch Bronconeumol. 1999 Apr;35(4):159-66. Spanish. — View Citation
Vardavas CI, Anagnostopoulos N, Kougias M, Evangelopoulou V, Connolly GN, Behrakis PK. Short-term pulmonary effects of using an electronic cigarette: impact on respiratory flow resistance, impedance, and exhaled nitric oxide. Chest. 2012 Jun;141(6):1400-1406. doi: 10.1378/chest.11-2443. Epub 2011 Dec 22. — View Citation
Vestbo J, Hurd SS, Agustí AG, Jones PW, Vogelmeier C, Anzueto A, Barnes PJ, Fabbri LM, Martinez FJ, Nishimura M, Stockley RA, Sin DD, Rodriguez-Roisin R. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease: GOLD executive summary. Am J Respir Crit Care Med. 2013 Feb 15;187(4):347-65. doi: 10.1164/rccm.201204-0596PP. Epub 2012 Aug 9. Review. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of inflammatory response | Assessment of the local inflammatory airway response measured by respiratory functional test and sputum culture, in addition to the evaluation of the systemic inflammatory response provided by determination of acute reactants in blood tests (determination of C-reactive protein and cytokines in blood sample) in COPD patients. | 8 weeks | |
Secondary | Clinical symptoms associated with COPD | Complete characterization of patients: tobacco consumption related symptoms: cough, oral irritation, dyspnoea. Control of the symptoms of nicotine withdrawal and evaluation test. | 8 weeks | |
Secondary | Tobacco withdrawal | Maintained smoking abstinence rate at 8 weeks in the electronic cigarette group. | 8 weeks |
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