Survey to determine the efficacy and safety of guideline-based pharmacological therapy for chronic obstructive pulmonary disease patients not previously receiving maintenance treatment

Abstract

Objective: To investigate the potential beneficial effects of guideline-based pharmacological therapy on pulmonary function and quality of life (QOL) in Japanese chronic obstructive pulmonary disease (COPD) patients without prior treatment.

Research design and methods: Multicenter survey, open-label study of 49 Japanese COPD patients aged ≥ 40 years; outpatients with >10 pack years of smoking history; ratio of forced expiratory volume in 1 s (FEV₁)/forced vital capacity (FVC) < 70%; predicted FEV₁ < 80%; treated with bronchodilators and/or inhaled corticosteroids as maintenance therapy until week 48.

Main outcome measures: The primary endpoint was change in pulmonary function (trough FEV₁, trough FVC); secondary endpoints were QOL and physical activity at 48 weeks after initiation of therapy.

Results: Airway reversibility was confirmed in untreated patients. Significant changes over time were not observed for FEV₁ and FVC, indicating lung function at initiation of treatment was maintained during the observation period. COPD assessment test scores showed statistical and clinical improvements. Cough, sputum, breathlessness, and shortness of breath were significantly improved.

Conclusions: Lung function and QOL of untreated Japanese COPD patients improved and improvements were maintained by performing a therapeutic intervention that conformed to published guidelines.

Keywords:

• chronic obstructive pulmonary disease
• chronic obstructive pulmonary disease assessment test
• forced expiratory volume in 1 second
• forced vital capacity
• long-acting bronchodilators
• quality of life

Acknowledgments

The authors would like to acknowledge the support of the following doctors at the participating centers for providing case details: Tomita Kazuhiro, M.D, Miki Yoshihiro, M.D, and Kazuma Kishi, M.D.

Declaration of interest

The authors would like to thank Dr J Ludovic Croxford for providing editorial assistance that was funded by the Comprehensive Support Project for Cooperative Clinical Research of the Public Health Research Foundation. This study was supported by a fund provided by the Comprehensive Support Project for Cooperative Clinical Research of the Public Health Research Foundation, partly by a Grand-in-Aid for Scientific Research (C) from the Japan Society for the Promotion of Science, and partly by a Health and Labour Science Research Grant from the Ministry of Health, Labour and Welfare. This study was registered with the University Hospital Medical Information Network (UMIN000005188). The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

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