The Efficacy and Safety of First-Line Single-Inhaler Triple versus Dual Therapy in Controller-Naïve and Symptomatic Adults with Asthma: A Preliminary Retrospective Cohort Study

Abstract

Purpose

The efficacy and safety of first-line triple and dual therapy remain unclear because the stepwise strategy is a worldwide standard in controller-naïve asthma. A preliminary retrospective cohort study was conducted to investigate the efficacy and safety of first-line triple and dual therapy for managing controller-naïve and symptomatic adult patients with asthma.

Patients and Methods

Patients with asthma who received first-line single-inhaler triple therapy (SITT) or dual therapy (SIDT) for at least 8 weeks were selected between December 1, 2020, and May 31, 2021, in Fujiki Medical and Surgical Clinic, Miyazaki, Japan. Data on daytime and nighttime visual analog scale (VAS) scores, lung function tests, fractional exhaled nitrogen oxide (F_ENO), and adverse events were compared between SITT and SIDT pre- and post-treatment.

Results

The SITT significantly improved the nighttime, but not daytime, VAS scores better than the SIDT 2 weeks post-treatment (P = 0.0026), whereas SITT and SIDT significantly improved daytime and nighttime VAS scores after treatment compared to baseline. Both therapies also significantly improved lung functions and F_ENO post-treatment. The proportion of patients achieving complete control in the nighttime VAS scores after SITT was significantly higher than that four (P = 0.0186) and 8 weeks (P = 0.0061) after SIDT. Only patients with SITT experienced dry mouth.

Conclusion

Our study demonstrated that first-line SITT and SIDT were effective, and SITT improved disease control faster than SIDT in controller-naïve and symptomatic adult patients with asthma. The first-line SITT may contribute to faster and better control levels in symptomatic patients with asthma.

Keywords:

• adult
• asthma
• cohort study
• corticosteroids
• Japanese

Abbreviations

ACT, asthma control test; COPD, chronic pulmonary obstructive disease; FEV_1, forced expiratory volume in 1 second; FVC, forced vital capacity; F_ENO, fractional exhaled nitrogen oxide; GINA, Global Initiative for Asthma; HRQoL, health-related quality of life; ICS, inhaled corticosteroid; LABA, long-acting beta-2 agonist; LAMA, long-acting muscarinic antagonist; MCID, minimal clinically important difference; OR, odds ratio; %FEV₁ predicted, percent predicted value of FEV₁; %FVC predicted, percent predicted value of FVC; pMDI, pressurized metered dose inhaler; UMIN, University Hospital Medical Information Network; PROs, patient-reported outcomes; SIDT, single-inhaler dual therapy; SITT, single-inhaler triple therapy; SD, standard deviation; VAS, visual analog scale.

Acknowledgments

We thank the authors for helping with data collection and management and all members of the Fujiki Medical and Surgical Clinic, Miyazaki, Japan.

Disclosure

Prof. Tomotaka Kawayama reports grants from Helios co. Ltd. and lecture fees from GlaxoSmithKline (GSK), AstraZeneca, Boehringer Ingelheim, Sanofi, Novartis, Kyorin, and Teijin healthcare. Dr Takashi Kinoshita reports grants from GSK and AstraZeneca and a lecture fee from AstraZeneca. Prof. Tomoaki Hoshino reports a grant from GSK, Novartis, and Chugai Pharmaceutical. The rest of the authors have no potential conflicts of interest in this study.

Additional information

Funding

There was no funding for this work.