A CLINICAL STUDY ON SAFETY AND EFFICACY OF FORMOTEROL AND TIOTROPIUM COMBINATION COMPARED TO FORMOTEROL AND TIOTROPIUM WITH ROFLUMILAST COMBINATION IN TREATMENT OF MODERATE TO SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE PATIENTS
DOI:
https://doi.org/10.22159/ajpcr.2018.v11i3.21871Keywords:
Roflumilast, Tiotropium, Formoterol, SpirometryAbstract
 Objectives: The objective of this study is to assess the safety and efficacy of formoterol and tiotropium combination compared to formoterol and tiotropium with roflumilast combination in treatment of moderate-to-severe chronic obstructive pulmonary disease (COPD) patients on inhaled combination therapy.
Methods: A comparative prospective interventional study was carried out in 61 COPD patients who were visiting the pulmonary medicine ward during 6 months (October 2016 to March 2017). The patients were randomized into two groups. Group A patients received a combination of formoterol and tiotropium, whereas Group B patients received roflumilast along with formoterol and tiotropium combination. Spirometry tests were done to both the study population. Forced expiratory volume in 1 second (FEV1) and forced vital capacity (FVC) were noted at the initial visit and after the treatment. All the statistical analyses such as mean and p values were calculated using SPSS 14.0 version software.
Results: The average age group of the study population was 57.63±8.3 years. Comorbid condition such as diabetes mellitus was higher in the study groups. Comparison of spirometry reports before and after drug administration in both groups was done. FEV1 and FVC were found to be statistically significant between the study group (0.001, p<0.05).The average mean change of FEV1 before and after treatment in Group B was found to be improved as compared to Group B (0.66).
Conclusion: Tiotropium and formoterol with roflumilast combination were found to be safe and effective in moderate-to-severe COPD patients.
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References
Global Initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of Chronic Obstructive Pulmonary Disease. Global Initiative for Chronic Obstructive Lung Disease (GOLD). Available from: . [Last updated on 2011 ].
Tageldin MA, Nafti S, Khan JA, Nejjari C, Beji M, Mahboub B, et al. Distribution of COPD-related symptoms in the middle east and north Africa: Results of the BREATHE study. Respir Med 2012;106 Suppl 2:S25-32.
Pauwels RA, Buist AS, Calverley PM, Jenkins CR, Hurd SS, GOLD Scientific Committee, et al. 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.
Standardization of spirometry, 1994 update. American thoracic society. Am J Respir Crit Care Med 1995;152:1107-36.
Altaf M, Masood QM, Ahamed TZ. Health related quality of life assessment using ST. George’s respiratory questionnaire in chronic obstructive pulmonary disease patients on combined inhaled corticosteroids and bronchodilators. Int J Pharm Pharm Sci 2016;8:445-9.
Postma D, Anzueto A, Calverley P, Jenkins C, Make BJ, Sciurba FC, et al. A new perspective on optimal care for patients with COPD. Prim Care Respir J 2011;20:205-9.
Unni A, Jayaprakash AK, Yadhukrishnan MC, Umadevi P. Drug utilization pattern in chronic obstructive pulmonary disease inpatients at a tertiary care hospital. Int J Pharm Pharm Sci 2015;11:389-91.
Perera WR, Hurst JR, Wilkinson TM, Sapsford RJ, Müllerova H, Donaldson GC, et al. Inflammatory changes, recovery and recurrence at COPD exacerbation. Eur Respir J 2007;29:527-34.
Bhowmik A, Seemungal TA, Sapsford RJ, Wedzicha JA. Relation of sputum inflammatory markers to symptoms and lung function changes in COPD exacerbations. Thorax 2000;55:114-20.
Calverley PM, Rabe KF, Goehring UM, Kristiansen S, Fabbri LM, Martinez FJ, et al. Roflumilast in symptomatic chronic obstructive pulmonary disease: Two randomised clinical trials. Lancet 2009;374:685-94.
Ferguson GT. Recommendations for the management of COPD. Chest 2000;117:23S-8S.
Vincken W, Vandevoorde J. Early detection of COPD: Etiology and acute effects. Respir Med 2007;101:525-30.
Salvi SS, Barnes PJ. Chronic obstructive pulmonary disease in non-smokers. Lancet 2009;374:733-43.
Barnes PJ, Celli BR. Systemic manifestations and comorbidities of COPD. Eur Respir J 2009;33:1165-85.
Gross NJ, Glembycz MA. Treatment of COPD with roflumilast, a new PDE4 inhibitor. COPD J Chronic Obstr Pulm Dis 2010;7:141-53.
Fabbri LM, Calverley PM. Roflumilast in moderate to severe COPD treating with long acting bronchodilators: Two randomized clinical trials. Lancet 2009;374:695-703.
Wells JM, Jackson PL, Viera L, Bhatt SP, Gautney J, Handley G, et al. A randomized, placebo-controlled trial of roflumilast. Effect on proline-glycine-proline and neutrophilic inflammation in chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2015;192:934-42.
Calverley PM, Martinez FJ, Fabbri LM, Goehring UM, Rabe KF. Does roflumilast decrease exacerbations in severe COPD patients not controlled by inhaled combination therapy? The REACT study protocol. Int J Chron Obstruct Pulmon Dis 2012;7:375-82.
Currie GP, Clarie A. PDE-4 inhibitor in COPD: A new approach to oral treatment. Br J Clin Pharmacol 2007;65:803-10.
Ulrik CS, Calverley PM. Roflumilast: Clinical benefit in patients suffering from COPD. Clin Respir J 2010;4:197-201.
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