Research Topic
The research question had been developed utilizingthe PICOT format, where the COPD patients are the Population, Indacaterol–Glycopyrronium is the chosen Intervention, not usingIndacaterol–Glycopyrronium is the comparison element, the outcome is reduced frequency of exacerbation events, and lastly the time frame chosen is the one year interval for the intervention to work. The research for the paper was done using each phrase in different combination to find credible and relevant articles from the databases. Only the articles that are peer reviewed were chosen.
This multicentre, double blind, double-dummy, parallel-group randomized control trial study had used the dual bronchodilator named the QVA149 which is a fixed dose inhaler used in combination therapy. Criticizing the study design, the randomized control trials are the highest level of evidence along with being a primary research which fits the criteria for this assignment as well (Bowling, 2014). The double blind and double dummy design for the study indicates that both the researchers and the participants did not know what they are being given for the intervention, which limits the chances of bias to a large extent. The dual bronchodilator intervention of the COPD was compared with the standard treatment of salmeterol–fluticasone. The process of the data analysis used the effective and efficient SAS version 9.1. The ethics was upheld by taking the assistance of institutional review boards and ethics committees at participating centres in accordance with Declaration of Helsinki and Good Clinical Practice. Data findings indicated a 5% reduction in the incidence rate of COPD exacerbation events in the patients. The findings had been consistent with the claims made however there is no mention of the possible strengths and limitation of the study (Vogelmeier et al., 2013).
The chronic obstructive pulmonary disorder is considered to be one of the most pressing and emerging type of the lower respiratory disorders that adds a considerable amount to the disease burden (Tee et al., 2018). The implementation of Indacaterol–Glycopyrronium treatment has been reported to effectively reduce the frequency and severity of the exacerbation events drastically (Mahler et al., 2015). This research question therefore focuses on the effectiveness and efficiency of this particular treatment intervention in comparison to the regular or standard therapy to reduce the exacerbation event plausibility.
In the statistical data identified that 600,000 people in Australia were living with COPD with 7,991 deaths caused due to COPD (Health.gov.au, 2018). Hence the disease burden for this particular condition is extremely high and it also contributes 5% of the total number of deaths in the Australia. There is need for better and more effective intervention that can reduce the frequency and severity of the exacerbation events (Frith et al., 2015). The dual bronchodilator QVA149 can has previously been reported to show superior efficiency in reducing the COPD exacerbation likelihood in patients along with having a significant positive impact on the dyspnoea and activity intolerance for the patients as well improving the life style quality for patients with moderate to severe COPD as well (Zhong et al., 2015). Hence, if integrated with the national chronic disease management framework strategies for treatment, this particular intervention can help in reducing the burden of this diseases for the Australian demographics significantly (Aihw.gov.au, 2018).
Review of Literature
This primary resource by Vogelmeier et al., (2013) focussed on the effectiveness of the administration of a dual bronchodilator for the COPD patients in order to reduce the probability and frequency of the COPD exacerbation events. This randomized control trial by Vogelmeier et al. (2013) has attempted to discuss the impact of the administration of indacaterol which is a long- acting β2-agonist with glycopyrronium which a long acting muscarinic antagonist as a fixed dose of dual bronchodilator on the patients with moderate to severe COPD exacerbations. The article attempted to research the efficacy, safety, and tolerability of this intervention to the standard treatment of salmeterol–fluticasone (SFC) for the intervention of 26 weeks. This research study has incorporated a multicentre, double blind, double-dummy, parallel-group randomized control trial study design. The benefits of the double dummy study design is that it is a technique that allowed both of the intervention to not be identical, which is a commendable strength of the study. Among the 259 patients that have been selected for participation, the group with QVA149 administration had 55.4% of overall incidence rate whereas the second intervention group with the regular SFC treatment had 60.2% incidence rate, which indicates at a considerable 5% reduction in the adverse event rate in just 26 weeks. Along with that, the article also discusses that the once daily administration of the QVA149 can effectively provide significant, sustained, and clinically meaningful improvements in lung function when compared to the twice daily administration of the SFC (Vogelmeier et al., 2013). Hence, it can be deduced that the integration of the dual bronchodilator in standard treatment can effectively reduce the financial and physical exhaustion of treatment with lesser side effects.
The second primary research article chosen for this review study is by Wedzicha et al. (2016), which is also a double blind double dummy randomized trail alike the first article chosen, however, the time limit for this research study has been 52 weeks. This randomized, double-blind, double-dummy, noninferiority trial attempted to explore the role of treatment with a LAMA-LABA regimen with the combination of glycopyrronium which is a long acting beta agonist and indacaterol which is a long-acting muscarinic antagonist. The sampling for the research study was randomized involving 1680 patients for the indacaterol–glycopyrronium group and 1682 patients for salmeterol–fluticasone group. The results in this case indicated that the indacaterolglycopyrronium group took longer time interval for the first exacerbation event to occur than the comparison group, and the annual risk rate for this group also represented a 16% lower risk. A novel information this article provided is the fact that the indacaterol–glycopyrronium intervention group results were also independent of baseline blood eosinophil count. Although the difference in the total number of adverse events were similar in both groups, the difference was significant. The incidence of the pneumonia in case of the indacaterol–glycopyrronium intervention group was 3.2% whereas for the standard group had been 4.8%. Hence, it can be mentioned that for the COPD patients the intervention of the indacaterol–glycopyrroniumis more effective (Wedzicha et al., 2016).
The third article chosen by the Zhong et al. (2015) is a LANTERN study, a double-blind, double-dummy, parallel-group study which had been based on the current global initiative for the COPD treatment which recommends the use of more than one bronchodilators with respect to the airflow restrictions of the patient. The participants chosen for the study had been 744 patients suffering from moderate to severe COPD with a history of <1 exacerbations in the last year with 1:1 QVA149 110/50 μg once daily or SFC 50/500 μg administered :twice daily for 26 week. The time limit in this case also had been 26 weeks, and the primary end point had been non- inferiority of QVA149 versus SFC for trough forced expiratory volume in 1 second (FEV1) at week 26. The data findings of this research article is also consistent with the rest of the two primary sources reviewed with QVA149 demonstrating statistically significant superiority to SFC for trough FEV1. Elaborating on the data findings, the primary objective set for non-inferiority between the QVA149 and SFC in trough FEV1 at week 26 was met. QVA149 was found to significantly reduce the rate of moderate or severe exacerbations by 31%, which aligns successfully with the results revealed by the previous articles. Along with that, the authors in this research study could also explain that the rate of pneumonia had also been three times lower for the patients that were administered QVA149. Hence, it can be concluded that all three primary sources identified the intervention of QVA149 to have significantly higher superior efficiency in reducing the exacerbation rate and pneumonia (Zhong et al., 2015). Hence, there is significantly promising implication of this intervention in future treatment or clinical practice.
The review identified three articles that focussed on the effectiveness and efficiency of the dual bronchodilator QVA149 or indacaterol–glycopyrronium over the regular treatment with salmeterol–fluticasone (SFC) across different time interventions (Wedzicha et al., 2017). All three of the articles were successful in proving the superiority of indacaterol–glycopyrronium over salmeterol–fluticasone in reducing the frequency of exacerbation events and prolonging the intervals between the events as well. The article by Zhong et al. (2015) and Wedzicha et al. (2016) has also been able to identify indacaterol–glycopyrronium to reduce the probability of pneumonia in patients with moderate to severe COPD as well, which is a very common complication for COPD. However, neither of the articles incorporated the cost effectiveness of this intervention at all, which is a very important aspect for this intervention to be incorporated in the national strategic chronic disease management framework in large scale clinical practice. Hence. There is need for further research to be carried out to explore the cost effectiveness of this dual bronchodilator in large scale clinical practice. The recommended study design in this case is observational cohort study to explore the financial feasibility of integrating the indacaterol–glycopyrronium in clinical practice (Green &Thorogood, 2018).
Vogelmeier, C. F., Bateman, E. D., Pallante, J., Alagappan, V. K., D’Andrea, P., Chen, H., &Banerji, D. (2013). Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol–fluticasone in patients with chronic obstructive pulmonary disease (ILLUMINATE): a randomised, double-blind, parallel group study. The Lancet Respiratory Medicine, 1(1), 51-60. doi: 10.1016/S2213-2600(12)70052-8
This randomized multicentre double-blind, double-dummy, parallel-group study explored the effectiveness of QVA149 dual bronchodilator over salmeterol–fluticasone in patients with moderate to severe COPD. The results indicated Once-daily QVA149 to provide significant, sustained, and clinically meaningful effects in lung function and limit the likelihood of exacerbations.
Wedzicha, J. A., Banerji, D., Chapman, K. R., Vestbo, J., Roche, N., Ayers, R. T., …&Vogelmeier, C. F. (2016). Indacaterol–glycopyrronium versus salmeterol–fluticasone for COPD. New England Journal of Medicine, 374(23), 2222-2234. doi: 10.1056/nejmoa1516385
This 52-week, randomized, double-blind, double-dummy, noninferiority trial explored the impact of LABA-LAMA regimen involving the indacaterol–glycopyrronium on the patients with moderate to severe COPD. The data findings indicated indacaterol–glycopyrronium to be more effective than the salmeterol–fluticasone in the patients consistently.
Zhong, N., Wang, C., Zhou, X., Zhang, N., Humphries, M., Wang, L., …&Banerji, D. (2015). LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD. International journal of chronic obstructive pulmonary disease, 10, 1015. doi: 10.2147/COPD.S84436
The LANTERN study evaluated the impact of indacaterol–glycopyrronium over salmeterol–fluticasone in COPD patients taking the study design of double-blind, double-dummy, parallel-group RCT. The data findings indicated QVA149 to be a potent alternative treatment over SFC for management of moderate to severe COPD.
Chronic disease Overview – Australian Institute of Health and Welfare. (2018). Retrieved from-https://www.aihw.gov.au/reports-statistics/health-conditions-disability-deaths/chronic-disease/overview
Frith, P. A., Thompson, P. J., Ratnavadivel, R., Chang, C. L., Bremner, P., Day, P., …& Glisten Study Group. (2015). Glycopyrronium once-daily significantly improves lung function and health status when combined with salmeterol/fluticasone in patients with COPD: the GLISTEN study—a randomised controlled trial. Thorax, 70(6), 519-527. doi: 10.1136/thoraxjnl-2014-206670
Green, J., &Thorogood, N. (2018). Qualitative methods for health research. Sage. Retrieved from https://books.google.co.in/books?hl=en&lr=&id=HUhLDwAAQBAJ&oi=fnd&pg=PP1&dq=Green,+J.,+%26Thorogood,+N.+(2018).+Qualitative+methods+for+health+research.+Sage.&ots=quEaXPMbTN&sig=tAfLwNfOP2ydQ4beCJZAfAzSwHs#v=onepage&q&f=false
Health.gov.au. (2018). Department of Health | National Strategic Framework for Chronic Conditions. [online] Available at: https://www.health.gov.au/internet/main/publishing.nsf/content/nsfcc [Accessed 30 Sep. 2018].
Mahler, D., Keininger, D., Fogel, R., Mezzi, K., &Banerji, D. (2015). QVA149 is more efficacious than tiotropium and salmeterol/fluticasone combination (SFC) in improving patient-reported outcomes and lung function in COPD patients with moderate-to-severe baseline dyspnoea: The IGNITE trials. doi: 10.1183/13993003.congress-2015.PA2966
Tee, A., Chow, W. L., Burke, C., &Guruprasad, B. (2018). Cost-effectiveness of indacaterol/glycopyrronium in comparison with salmeterol/fluticasone combination for patients with moderate-to-severe chronic obstructive pulmonary disease: a LANTERN population analysis from Singapore. Singapore medical journal, 59(7), 383. doi: 10.11622/smedj.2018022
Vogelmeier, C. F., Bateman, E. D., Pallante, J., Alagappan, V. K., D’Andrea, P., Chen, H., &Banerji, D. (2013). Efficacy and safety of once-daily QVA149 compared with twice-daily salmeterol–fluticasone in patients with chronic obstructive pulmonary disease (ILLUMINATE): a randomised, double-blind, parallel group study. The Lancet Respiratory Medicine, 1(1), 51-60. doi: 10.1016/S2213-2600(12)70052-8
Wedzicha, J. A., Banerji, D., Chapman, K. R., Vestbo, J., Roche, N., Ayers, R. T., …&Vogelmeier, C. F. (2016). Indacaterol–glycopyrronium versus salmeterol–fluticasone for COPD. New England Journal of Medicine, 374(23), 2222-2234. doi: 10.1056/nejmoa1516385
Wedzicha, J. A., Zhong, N., Ichinose, M., Humphries, M., Fogel, R., Thach, C., …&Banerji, D. (2017). Indacaterol/glycopyrronium versus salmeterol/fluticasone in Asian patients with COPD at a high risk of exacerbations: results from the FLAME study. International journal of chronic obstructive pulmonary disease, 12, 339. doi: 10.2147/COPD.S125058
Zhong, N., Wang, C., Zhou, X., Zhang, N., Humphries, M., Wang, L., …&Banerji, D. (2015). LANTERN: a randomized study of QVA149 versus salmeterol/fluticasone combination in patients with COPD. International journal of chronic obstructive pulmonary disease, 10, 1015. doi: 10.2147/COPD.S84436
Zhong, N., Wang, C., Zhou, X., Zhang, N., Patalano, F., Humphries, M., …&Banerji, D. (2015). C22 I FEEL FINE NOW: NEW TREATMENTS FOR COPD: Qva149 Significantly Lowers The Rate And Risk Of Moderate Or Severe COPD Exacerbation Versus Salmeterol/fluticasone In Patients With Moderate To Severe COPD: The Lantern Study. American Journal of Respiratory and Critical Care Medicine, 191, 1. doi: 10.1164/ajrccm-conference.2015.191.1
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