Aim: This study sought to compare the effectiveness of Roflumilast with placebo in patients who have moderate-to-severe COPD.

Objective: The primary objective was to measure lung function improvement, exacerbations and hospitalisations from a baseline at day 0 vs placebo for roflumilast. Secondary outcomes included quality of life and the safety of roflumilast treatment.

Methods: A total of 550 subjects who met the inclusion criteria (age group, COPD were GOLD stage 2-3 and absence of other significant respiratory diseases) participated in a randomized controlled trial. During the treatment phase, participants were randomized to receive roflumilast or placebo for 12 months. Lung function was estimated by spirometry, and participants were recorded the incidence of exacerbations and hospitalizations when they joined in this study via diaries rigorously and medical records strictly; QALYs were described as socioeconomically disturbing score applied according to patient-cantered outcome questionnaires at a useful time point. Adverse events were graded for severity and systematically recorded.

Results: Roflumilast significantly improved lung function with a 120 mL increase in FEV1 from placebo (P <0.001). The roflumilast arm had 28% fewer exacerbations than did the placebo group (rate ratio, 0.72; P <.001) and a lower hospitalization rate (20% vs. Adverse events were more common with roflumilast, predominantly gastrointestinal symptoms and weight loss (discontinuation rate 10 vs. 5 % placebo).

Summary: Roflumilast is an effective drug to improve lung function and reduce the frequency of exacerbations and hospital admissions in patients with moderate or severe COPD. Although adverse effects were manageable, the researchers said physicians should consider patient tolerability and provide an individualised risk profile. The findings of this study provide evidence for roflumilast as a useful choice in the management of COPD and will help to improve clinical results and quality life.

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