Management of COPD and comorbidities in COPD patients by dispensing pharmaceutical care following Global Initiative for Chronic Obstructive Lung Disease-guidelines (GOLD guidelines 2020): a prospective randomized clinical trial

BACKGROUND: Chronic Obstructive Pulmonary Disease (COPD) is a major global health burden, driving high rates of morbidity, mortality, and economic strain. Its prevalence is rising, especially among aging populations and in areas with heavy tobacco and pollutant exposure. Frequent comorbidities like cardiovascular disease and diabetes complicate care, necessitating multidisciplinary approaches beyond standard pharmacotherapy. METHODS AND FINDINGS: This prospective randomized clinical trial investigated the impact of individualized care aligned with Global initiative for chronic obstructive Lungs disease (GOLD guidelines)-on clinical outcomes in COPD patients with comorbidities. 120 patients were randomly allocated to three arms: standard care, pharmacist counselling, and comprehensive pharmaceutical care. Participants were followed for 24 weeks, and outcome measures included assessments of symptom severity (via CAT and mMRC scores), lung function (FEV₁), exacerbation frequency, and quality of life. Arm 2 (Pharmaceutical Care) significantly lowered CAT scores to 18.82 ± 13.69 compared to 29.88 ± 13.69 in the Arm 0 (control group) (p < 0.001) and reduced mMRC ratings to 0.91 ± 0.39 versus 1.36 ± 0.39 (p < 0.001). Arm 2 experienced the smallest FEV₁ (% predicted) change (-2.76 ± 2.52) versus -9.73 ± 2.52 in the control group, with a post-intervention mean difference of -9.70 ± 2.83 (p = 0.001). The duration of moderate exacerbations was significantly shorter in Arm 2 (1.50 ± 1.49 weeks) compared to 3.23 ± 1.49 weeks in controls (p < 0.001). Disease progression scores were lower in Arm 2 (1.15 ± 0.36) versus 1.45 ± 0.44 in the Arm 0 (p = 0.016). Quality of life significantly improved in the Arm 2 compared to Arm 0 and Arm 1, as reflected by lower SGRQ scores (p < 0.001). CONCLUSIONS: In conclusion, implementing pharmaceutical care based on GOLD 2020 guidelines not only enhances symptom management and preserves lung function but also significantly improves quality of life in COPD patients. This study underscores the critical role of pharmacists in multidisciplinary care teams, focusing the patient education and individualized patient care, especially in resource-limited settings. CLINICAL TRIAL REGISTRATION: This clinical trial has been registered in ANZCTR clinical trials registry: ACTRN12622000234718 (https://www.anzctr.org.au/ACTRN12622000234718.aspx). TRIAL REGISTRATION: This clinical trial has been registered in Australian New Zealand Clinical Trials Registry: Trial ID (ACTRN12622000234718), Date of registration 09/02/2022 and updated at 02/03/2023. TRIAL PROTOCOLS: These protocols are the detailed version of the registered clinical trial that has been published in Heliyon 10.1016/j.heliyon.2023.e21539.