HEALTH-RELATED QUALITY OF LIFE ASSESSMENT USING SINGLE-INHALER DUAL VERSUS TRIPLE THERAPY IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE PATIENTS

Authors

  • TALATH FATIMA Department of Pharmacy Practice, Deccan School of Pharmacy, Hyderabad, Telangana, India.
  • ANNIE FATIMA SADAF Department of Pharmacy Practice, Deccan School of Pharmacy, Hyderabad, Telangana, India.
  • SYED AAMIR ALI Department of Pharmacy Practice, Deccan School of Pharmacy, Hyderabad, Telangana, India.
  • JUNAID SIDDIQUI Department of Pharmacy Practice, Deccan School of Pharmacy, Hyderabad, Telangana, India.
  • MIRZA MISBA ALI BAIG Department of Pharmacy Practice, Deccan School of Pharmacy, Hyderabad, Telangana, India.
  • SYED MAHMOOD AHMED Department of Pulmonary Medicine, Owaisi Hospital and Research Center, Hyderabad, Telangana, India.
  • MEHRUQ FATIMA Department of Pharmacy Practice, Deccan School of Pharmacy, Hyderabad, Telangana, India.

DOI:

https://doi.org/10.22159/ajpcr.2020.v13i3.36392

Keywords:

Chronic obstructive pulmonary disease, St George respiratory questionnaire, Chronic obstructive pulmonary disease assessment test, Health-related quality of life, Lung function

Abstract

Objectives: The study compared triple therapy (inhaled corticosteroids/long-acting beta2-agonists [LABA]/long-acting muscarinic antagonists [LAMA]) versus dual therapy [LABA/LAMA] in improving lung function and health-related quality of life (HRQoL) of patients with chronic obstructive pulmonary disease (COPD).

Methods: This prospective and observational study compared 12 weeks of triple therapy (Formoterol – 6 mcg/Ciclesonide – 200 mcg/Tiotropium – 9 mcg) versus dual therapy (Formoterol – 6 mcg/Tiotropium – 9 mcg) in COPD patients. The primary objective included HRQoL as measured by improvement (decrease) from baseline in St. George respiratory questionnaire (SGRQ) score and COPD assessment test (CAT) scores. Coprimary endpoint included the change from baseline in forced expiratory volume in 1 second (FEV1).

Results: After 12 weeks of treatment, triple therapy (n=30) and dual therapy (30), mean improvement (decrease) from baseline in SGRQ scores was −21.06 (95% CI, −24.92–−17.20) and −5.89571 (95% CI, −7.71–−4.07), respectively, and mean improvement (decrease) from baseline in CAT scores was −2.83 (95% CI, −3.73–−1.94] and −1.8 (95% CI, −2.25–−1.35), respectively. The mean change from baseline in FEV1% predicted was 3.09 (95% CI, 2.18–4.00) and 1.69 (95% CI, 1.43–1.97) for triple and dual therapy, respectively. For all the endpoints, the between-group mean differences were statistically significant (p<0.001).

Conclusion: Triple therapy (Formoterol – 6 mcg/Ciclesonide – 200 mcg/Tiotropium – 9 mcg) can provide improvements in lung function and quality of life over dual therapy (Formoterol – 6 mcg/Tiotropium – 9 mcg) in patients with moderate to severe COPD. Future studies should focus on which drug combination of triple therapy is more effective and cost-effective than other possible triple therapy drug combinations.

Downloads

Download data is not yet available.

References

Global Initiative for Chronic Obstructive Lung Disease. Global Strategy for the Diagnosis, Management, and Prevention of Chronic Obstructive Pulmonary Disease; 2005. Available from: http://www.goldcopd.org. [Last accessed on 2019 Jul 15].

Miravitlles M, Ferrer M, Pont A, Zalacain R, Alvarez-Sala JL, Masa F, et al. Effect of exacerbations on quality of life in patients with chronic obstructive pulmonary disease: A 2 year follow up study. Thorax 2004;59:387-95.

Siler TM, Kerwin E, Singletary K, Brooks J, Church A. Efficacy and safety of umeclidinium added to fluticasone propionate/salmeterol in patients with COPD: Results of two randomized, double-blind studies. COPD 2016;13:1-10.

Siler TM, Kerwin E, Sousa AR, Donald A, Ali R, Church A. Efficacy and safety of umeclidinium added to fluticasone furoate/vilanterol in chronic obstructive pulmonary disease: Results of two randomized studies. Respir Med 2015;109:1155-63.

Pauwels RA, Buist AS, Calverley PM, Jenkins CR, Hurd SS, GOLD Scientific Committee. Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. NHLBI/ WHO Global Initiative for Chronic Obstructive Lung Disease (GOLD) Workshop summary. Am J Respir Crit Care Med 2001;163:1256-76.

Ferrer M, Alonso J, Morera J, Marrades RM, Khalaf A, Aguar MC, et al. Chronic obstructive pulmonary disease stage and health-related quality of life. The quality of life of chronic obstructive pulmonary disease study group. Ann Intern Med 1997;127:1072-9.

Guyatt GH, Berman LB, Townsend M, Pugsley SO, Chambers LW. A measure of quality of life for clinical trials in chronic lung disease. Thorax 1987;42:773-8.

Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George’s respiratory questionnaire. Am Rev Respir Dis 1992;145:1321-7.

Jones P, Harding G, Wiklund I, Berry P, Leidy N. Improving the process and outcome of care in COPD: Development of a standardised assessment tool. Prim Care Respir J 2009;18:208-15.

Jones PW, Harding G, Berry P, Wiklund I, Chen WH, Kline Leidy N. Development and first validation of the COPD assessment test. Eur Respir J 2009;34:648-54.

Cully JA, Graham DP, Stanley MA, Ferguson CJ, Sharafkhaneh A, Souchek J, et al. Quality of life in patients with chronic obstructive pulmonary disease and comorbid anxiety or depression. Psychosomatics 2006;47:312-9.

Hu J, Meek P. Health-related quality of life in individuals with chronic obstructive pulmonary disease. Heart Lung 2005;34:415-22.

Carrasco Garrido P, de Miguel Díez J, Rejas Gutiérrez J, Centeno AM, Gobartt Vázquez E, Gil de Miguel A, et al. Negative impact of chronic obstructive pulmonary disease on the health-related quality of life of patients. Results of the EPIDEPOC study. Health Qual Life Outcomes 2006;4:31.

Balcells E, Gea J, Ferrer J, Serra I, Orozco-Levi M, de Batlle J, et al. Factors affecting the relationship between psychological status and quality of life in COPD patients. Health Qual Life Outcomes 2010;8:108.

Cazzola M, MacNee W, Martinez FJ, Rabe KF, Franciosi LG, Barnes PJ, et al. Outcomes for COPD pharmacological trials: From lung function to biomarkers. Eur Respir J 2008;31:416-69.

Meguro M, Barley EA, Spencer S, Jones PW. Development and validation of an improved, COPD-specific version of the St. George respiratory questionnaire. Chest 2007;132:456-63.

Glaab T, Vogelmeier C, Buhl R. Outcome measures in chronic obstructive pulmonary disease (COPD): Strengths and limitations. Respir Res 2010;11:79.

Guyatt GH, Feeny DH, Patrick DL. Measuring health-related quality of life. Ann Intern Med 1993;118:622-9.

Vogelmeier CF, Bateman ED, Pallante J, Alagappan VK, D’Andrea P, Chen H, et al. 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. Lancet Respir Med 2013;1:51-60.

Westwood M, Bourbeau J, Jones PW, Cerulli A, Capkun-Niggli G, Worthy G. Relationship between FEV1 change and patient-reported outcomes in randomised trials of inhaled bronchodilators for stable COPD: A systematic review. Respir Res 2011;12:40.

Morishita-Katsu M, Nishimura K, Taniguchi H, Kimura T, Kondoh Y, Kataoka K, et al. The COPD assessment test and St George’s respiratory questionnaire: Are they equivalent in subjects with COPD? Int J Chron Obstruct Pulmon Dis 2016;11:1543-51.

Sciriha A, Lungaro-Mifsud S, Scerri J, Magro R, Camilleri L, Montefort S. Health status of COPD patients undergoing pulmonary rehabilitation: A comparative responsiveness of the CAT and SGRQ. Chron Respir Dis 2017;14:352-9.

Lipson DA, Barnhart F, Brealey N, Brooks J, Criner GJ, Day NC, et al. Once-daily single-inhaler triple versus dual therapy in patients with COPD. N Engl J Med 2018;378:1671-80.

Papi A, Vestbo J, Fabbri L, Corradi M, Prunier H, Cohuet G, et al. Extrafine inhaled triple therapy versus dual bronchodilator therapy in chronic obstructive pulmonary disease (TRIBUTE): A double-blind, parallel group, randomised controlled trial. Lancet 2018;391:1076-84.

Lipson DA, Barnacle H, Birk R, Brealey N, Locantore N, Lomas DA, et al. FULFIL trial: Once-daily triple therapy for patients with chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2017;196:438-46.

Singh D, Papi A, Corradi M, Pavlišová I, Montagna I, Francisco C, et al. Single inhaler triple therapy versus inhaled corticosteroid plus long-acting β2-agonist therapy for chronic obstructive pulmonary disease (TRILOGY): A double-blind, parallel group, randomised controlled trial. Lancet 2016;388:963-73.

Khan PA, Sujala A, Nousheen BS, Fatima AF, Ala HT, Reddy AP. A comparative evaluation of the efficacy of triple drug therapy with dual drug therapy in COPD patients. Int J Pharm Pharm Sci 2018;10:105-9.

Zayed Y, Barbarawi M, Kheiri B, Haykal T, Chahine A, Rashdan L, et al. Triple versus dual inhaler therapy in moderate-to-severe COPD: A systematic review and meta-analysis of randomized controlled trials. Clin Respir J 2019;13:413-28.

Published

07-03-2020

How to Cite

FATIMA, T., A. F. SADAF, S. AAMIR ALI, J. SIDDIQUI, M. M. ALI BAIG, S. M. AHMED, and M. FATIMA. “HEALTH-RELATED QUALITY OF LIFE ASSESSMENT USING SINGLE-INHALER DUAL VERSUS TRIPLE THERAPY IN CHRONIC OBSTRUCTIVE PULMONARY DISEASE PATIENTS”. Asian Journal of Pharmaceutical and Clinical Research, vol. 13, no. 3, Mar. 2020, pp. 47-52, doi:10.22159/ajpcr.2020.v13i3.36392.

Issue

Section

Original Article(s)