Emerging Therapeutic Options for the Management of COPD

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Abstract

Chronic obstructive pulmonary disease (COPD) is the fourth leading cause of death worldwide and is projected to be the third by 2020. COPD is characterized by chronic airflow limitation caused by airway inflammation and parenchymal destruction that is usually progressive. Inhaled bronchodilators continue to be the mainstay of the current management of COPD. Safety and efficacy data of the recently approved medications including aclidinium, glycopyrronium, roflumilast, and indacaterol are reviewed here.

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Most cited references 38

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Once-daily bronchodilators for chronic obstructive pulmonary disease: indacaterol versus tiotropium.

James Donohue, Charles Fogarty, Jan Lötvall … (2010)

Indacaterol is the first once-daily, long-acting inhaled beta(2)-agonist bronchodilator studied in patients with chronic obstructive pulmonary disease (COPD). To demonstrate greater efficacy of indacaterol versus placebo on FEV(1) at 24 hours post dose (trough) after 12 weeks, to compare efficacy with placebo and tiotropium, and to evaluate safety and tolerability over 26 weeks. Patients with moderate-to-severe COPD were randomized to double-blind indacaterol 150 or 300 microg or placebo, or open-label tiotropium 18 microg, all once daily, for 26 weeks. The primary efficacy outcome was trough FEV(1) at 12 weeks. Additional analyses (not adjusted for multiplicity) included transition dyspnea index (TDI), health status (St George's Respiratory Questionnaire [SGRQ]), and exacerbations. Serum potassium, blood glucose, and QTc interval were measured. A total of 1,683 patients (age, 63.3 yr; post-bronchodilator FEV(1), 56% predicted; FEV(1)/FVC, 0.53) were randomized to the four treatment arms. Trough FEV(1) at Week 12 increased versus placebo by 180 ml with both indacaterol doses and by 140 ml with tiotropium (all P < 0.001 vs. placebo). At Week 26, for indacaterol 150/300 microg, respectively, versus placebo, TDI increased (1.00/1.18, P < 0.001) and SGRQ total score decreased (-3.3/-2.4, P < 0.01); corresponding results with tiotropium were 0.87 (P < 0.001) for TDI and (-1.0, P = not significant) for SGRQ total score. The incidence of adverse events, low serum potassium, high blood glucose, and prolonged QTc interval was similar across treatments. Indacaterol was an effective once-daily bronchodilator and was at least as effective as tiotropium in improving clinical outcomes for patients with COPD. Clinical trial registered with clinicaltrials.gov (NCT 00463567).

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Minimal clinically important differences in COPD lung function.

James Donohue (2005)

The FEV1 is widely used by physicians in the diagnosis, staging, treatment, monitoring, and establishing prognosis for patients with COPD. The MCID is the smallest difference which patients perceive as beneficial and which would mandate a change in patient management. A precise MCID for FEV1 has not been established. In attempt to establish a MCID for predose or trough FEV1, several limitations need to be addressed. There are issues such as reproducibility, repeatability, acceptability, variability, placebo effect, and equipment effects. Patient factors, such as baseline level of FEV1, albuterol reversibility, diurnal variation, influence the results. Nonetheless, using anchoring techniques, a change in pre dose FEV1 of about 100 mL can be perceived by patients, correlates with fewer relapses following exacerbations and is in the range usually achieved with bronchodilators approved for COPD. In the future, consistent reporting of spirometric variables, such as a predose FEV1 and other outcomes, can be incorporated into a more quantitative effort to establish the MCID. Also distributional/statistical methods may be useful in determining the MCID FEV1.

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Roflumilast--an oral anti-inflammatory treatment for chronic obstructive pulmonary disease: a randomised controlled trial.

Klaus F Rabe, Eric D Bateman, Denis Eunan O'Donnell … (2015)

Chronic obstructive pulmonary disease (COPD) is characterised by progressive airflow limitation associated with chronic inflammation. There are few treatment options for the disease. This study assessed the efficacy and safety of roflumilast, a phosphodiesterase-4 inhibitor, in patients with moderate to severe COPD. This phase III, multicentre, double-blind, randomised, placebo-controlled study was undertaken in an outpatient setting. 1411 patients with COPD were randomly assigned roflumilast 250 microg (n=576), roflumilast 500 microg (n=555), or placebo (n=280) given orally once daily for 24 weeks. Primary outcomes were postbronchodilator FEV1 and health-related quality of life. Secondary outcomes included other lung function parameters and COPD exacerbations. Analyses were by intention to treat. 1157 (82%) patients completed the study; 32 (11%) withdrew from the placebo group, 100 (17%) from the roflumilast 250 microg group, and 124 (22%) from the roflumilast 500 microg group. Postbronchodilator FEV1 at the end of treatment significantly improved with roflumilast 250 microg (by 74 mL [SD 18]) and roflumilast 500 microg (by 97 mL [18]) compared with placebo (p<0.0001). Improvement in health-related quality of life was greater with roflumilast 250 microg (-3.4 units [0.6]) and roflumilast 500 microg (-3.5 units [0.6]) than with placebo (-1.8 units [0.8]), although the differences between treatment groups were not significant. The mean numbers of exacerbations per patient were 1.13 (2.37), 1.03 (2.33), and 0.75 (1.89) with placebo, roflumilast 250 microg, and roflumilast 500 microg, respectively. Most adverse events were mild to moderate in intensity and resolved during the study. Roflumilast is a promising candidate for anti-inflammatory COPD treatment because it improved lung function and reduced exacerbations compared with placebo. Long-term studies are needed to fully assess the effect on health-related quality of life.

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Author and article information

Journal

Journal ID (nlm-ta): Clin Med Insights Circ Respir Pulm Med

Journal ID (iso-abbrev): Clin Med Insights Circ Respir Pulm Med

Title: Clinical Medicine Insights. Circulatory, Respiratory and Pulmonary Medicine

Publisher: Libertas Academica

ISSN (Electronic): 1179-5484

Publication date Collection: 2013

Publication date (Electronic): 09 April 2013

Volume: 7

Pages: 7-15

Affiliations

Department of Pharmacy Practice, School of Pharmacy, Northeastern University, Boston, MA, USA.

Author notes

Corresponding author email: d.reid@ 123456neu.edu

Article

Publisher ID: ccrpm-7-2013-007

DOI: 10.4137/CCRPM.S8140

PMC ID: 3629926

PubMed ID: 23641160

SO-VID: a4adb501-c199-498f-a744-4c93356e67a0

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This is an open access article. Unrestricted non-commercial use is permitted provided the original work is properly cited.

Emerging Therapeutic Options for the Management of COPD

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Abstract

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Biomarkers for Inflammatory Lung Disease

Most cited references 38

Once-daily bronchodilators for chronic obstructive pulmonary disease: indacaterol versus tiotropium.

Minimal clinically important differences in COPD lung function.

Roflumilast--an oral anti-inflammatory treatment for chronic obstructive pulmonary disease: a randomised controlled trial.

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