Chronic Obstructive Pulmonary Disease Clinical Trial
Official title:
Pulmonary Gas Exchange Response to Indacaterol in Stable Symptomatic Chronic Obstructive Pulmonary Disease Patients
To evaluate the pulmonary gas exchange response to a therapeutic high dose of inhaled
indacaterol (300 mcg) in 20 outpatients with stable symptomatic COPD B and D GOLD 2011
groups.
Measurements on a single day before and after 60 and 120 minutes of indacaterol will include
arterial PO2, PaCO2 and pH. AaPO2; SaO2 (by pulse oximetry) and oxygen and carbon dioxide in
exhaled breath, systemic arterial pressure and heart rate will also be measured/calculated.
Cardiac output will be directly measured by bio-impedance.
Status | Not yet recruiting |
Enrollment | 20 |
Est. completion date | November 2015 |
Est. primary completion date | October 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Outpatients with COPD diagnosis according to GOLD 2011 criteria (VEF1/CVF less than 70%), groups B and D. Exclusion Criteria: - Conditions or serious comorbidities (i.e., asthma, bronchiectasis, lung cancer and/or cardiovascular diseases). - Patients with frequent exacerbations (2 or more exacerbations in the past year). - History of acute COPD exacerbation in the previous 3 months. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Clínic | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Hospital Clinic of Barcelona |
Spain,
Cazzola M, Segreti A, Stirpe E, Puxeddu E, Ora J, Rogliani P, Matera MG. Effect of an additional dose of indacaterol in COPD patients under regular treatment with indacaterol. Respir Med. 2013 Jan;107(1):107-11. doi: 10.1016/j.rmed.2012.09.022. Epub 2012 Oct 18. — View Citation
Gabrijelcic J, Casas A, Rabinovich RA, Roca J, Barberà JA, Chung KF, Rodríguez-Roisin R. Formoterol protects against platelet-activating factor-induced effects in asthma. Eur Respir J. 2004 Jan;23(1):71-5. — View Citation
Kew KM, Dias S, Cates CJ. Long-acting inhaled therapy (beta-agonists, anticholinergics and steroids) for COPD: a network meta-analysis. Cochrane Database Syst Rev. 2014 Mar 26;3:CD010844. doi: 10.1002/14651858.CD010844.pub2. Review. — View Citation
Kew KM, Mavergames C, Walters JA. Long-acting beta2-agonists for chronic obstructive pulmonary disease. Cochrane Database Syst Rev. 2013 Oct 15;10:CD010177. doi: 10.1002/14651858.CD010177.pub2. Review. — View Citation
Khoukaz G, Gross NJ. Effects of salmeterol on arterial blood gases in patients with stable chronic obstructive pulmonary disease. Comparison with albuterol and ipratropium. Am J Respir Crit Care Med. 1999 Sep;160(3):1028-30. — View Citation
Pillet O, Manier G, Castaing Y. Anticholinergic versus beta 2-agonist on gas exchange in COPD: a comparative study in 15 patients. Monaldi Arch Chest Dis. 1998 Feb;53(1):3-8. — View Citation
Polverino E, Gómez FP, Manrique H, Soler N, Roca J, Barberà JA, Rodríguez-Roisin R. Gas exchange response to short-acting beta2-agonists in chronic obstructive pulmonary disease severe exacerbations. Am J Respir Crit Care Med. 2007 Aug 15;176(4):350-5. Epub 2007 Apr 12. — View Citation
Roskell NS, Anzueto A, Hamilton A, Disse B, Becker K. Once-daily long-acting beta-agonists for chronic obstructive pulmonary disease: an indirect comparison of olodaterol and indacaterol. Int J Chron Obstruct Pulmon Dis. 2014 Jul 31;9:813-24. doi: 10.2147/COPD.S59673. eCollection 2014. Review. — View Citation
Viegas CA, Ferrer A, Montserrat JM, Barberà JA, Roca J, Rodriguez-Roisin R. Ventilation-perfusion response after fenoterol in hypoxemic patients with stable COPD. Chest. 1996 Jul;110(1):71-7. Erratum in: Chest 1997 Jan;111(1):258. — View Citation
Whale CI, Sovani MP, Mortimer K, Oborne J, Cooper S, Harrison TW, Tattersfield AE. Effects of rac-albuterol on arterial blood gases in patients with stable hypercapnic chronic obstructive pulmonary disease. Br J Clin Pharmacol. 2006 Aug;62(2):153-7. — View Citation
Zafar MA, Droege C, Foertsch M, Panos RJ. Update on ultra-long-acting ß agonists in chronic obstructive pulmonary disease. Expert Opin Investig Drugs. 2014 Dec;23(12):1687-701. doi: 10.1517/13543784.2014.942730. Epub 2014 Aug 19. Review. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in PaO2 after indacaterol. | 60 and 120 minutes | No | |
Secondary | Change in PaCO2 after indacaterol. | 60 and 120 minutes | No | |
Secondary | Change in D(A-a)DO2 after indacaterol. | 60 and 120 minutes | No | |
Secondary | Change in pH after indacaterol. | 60 and 120 minutes | No | |
Secondary | Change in cardiac output after indacaterol. | 60 and 120 minutes | No |
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