Trial reportInternational journal of chronic obstructive pulmonary disease2019
The IMPACT Study - Single Inhaler Triple Therapy (FF/UMEC/VI) Versus FF/VI And UMEC/VI In Patients With COPD: Efficacy And Safety In A Japanese Population.
Trial report in International journal of chronic obstructive pulmonary disease, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers, 4 of them syntheses that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
18 citing papers in PubMed, 4 syntheses or guidelines pooled it.
- Comparative effectiveness of triple versus dual inhaled therapy (ICS/LABA or LABA/LAMA) for chronic obstructive pulmonary disease: a systematic review and network meta-analysis.BMC pulmonary medicine · 2026Pooled it
- Evaluation of comparative efficacy of Umeclidinium/Vilanterol versus other bronchodilators in the management of chronic obstructive pulmonary disease: a systematic review and meta-analysis of RCTs.BMC pulmonary medicine · 2024Pooled it
- Digital remote maintenance inhaler adherence interventions in COPD: a systematic review and meta-analysis.European respiratory review : an official journal of the European Respiratory Society · 2024Pooled it
- Inhaled corticosteroids with combination inhaled long-acting beta2-agonists and long-acting muscarinic antagonists for chronic obstructive pulmonary disease.The Cochrane database of systematic reviews · 2023Pooled it
- Comparison of the Risk of Pneumonia Between Fluticasone Furoate/Umeclidinium/Vilanterol and Multiple-Inhaler Triple Therapy in Patients with COPD Using Health Insurance Claims Data: Final Analysis of Post-Marketing Database Surveillance in Japan.Journal of clinical medicine · 2025Article
- Sputum Microbiome, Potentially Pathogenic Organisms, and Clinical Outcomes in Japanese Patients with COPD and Moderate Airflow Limitation: The Prospective AERIS-J Study.International journal of chronic obstructive pulmonary disease · 2025Observational
- Health Status Progression Measured Using Weekly Telemonitoring of COPD Assessment Test Scores Over 1 Year and Its Association With COPD Exacerbations.Chronic obstructive pulmonary diseases (Miami, Fla.) · 2024Article
- Comorbidities in COPD: Current and Future Treatment Challenges.Journal of clinical medicine · 2024Review
- Efficacy and safety of once-daily single-inhaler triple therapy for mild-to-moderate chronic obstructive pulmonary disease: a study protocol for a randomised and interventional study.BMJ open respiratory research · 2023Article
- Therapeutic Response to Single-Inhaler Triple Therapies in Moderate-to-Severe COPD.Respiratory care · 2023Article
- Real-World Evidence on the Diagnostic and Clinical Characteristics of Asthma in Japanese Patients with COPD: The ACO Japan Cohort Study.International journal of chronic obstructive pulmonary disease · 2023Observational
- The Impact of 52-Week Single Inhaler Device Triple Therapy versus Dual Therapy on the Mortality of COPD Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials.Life (Basel, Switzerland) · 2022Review
- A Telemedicine Approach for Monitoring COPD: A Prospective Feasibility and Acceptability Cohort Study.International journal of chronic obstructive pulmonary disease · 2022Article
- Narrative review of current COPD status in Japan.Journal of thoracic disease · 2021Review
- One-year clinically important deterioration and long-term clinical course in Japanese patients with COPD: a multicenter observational cohort study.BMC pulmonary medicine · 2021Observational
- Characteristics of and reasons for patients with chronic obstructive pulmonary disease to continue smoking, quit smoking, and switch to heated tobacco products.Tobacco induced diseases · 2021Article
- Safety of Once-Daily Single-Inhaler Triple Therapy with Fluticasone Furoate/Umeclidinium/Vilanterol in Japanese Patients with Asthma: A Long-Term (52-Week) Phase III Open-Label Study.Journal of asthma and allergy · 2021Article
- Annual Body Weight Change and Prognosis in Chronic Obstructive Pulmonary Disease.International journal of chronic obstructive pulmonary diseaseArticle
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Purpose: The Informing the Pathway of COPD Treatment (IMPACT) study demonstrated that single-inhaler triple therapy fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) reduces moderate/severe exacerbation rates and improves lung function and health status versus FF/VI or UMEC/VI dual therapy in patients with symptomatic COPD and a history of exacerbations. This analysis evaluated the efficacy and safety of FF/UMEC/VI in patients enrolled in Japan. Patients and methods: IMPACT was a 52-week, randomized, double-blind, multicenter study comparing FF/UMEC/VI 100/62.5/25 µg with FF/VI 100/25 µg or UMEC/VI 62.5/25 µg in patients ≥40 years with symptomatic COPD and ≥1 moderate/severe exacerbation in the previous year. Endpoints included annual rate of on-treatment moderate/severe exacerbations (primary endpoint), time-to-first on-treatment moderate/severe exacerbation and change from baseline at Week 52 in trough FEV Results: The Japan subgroup accounted for only 4% (378/10,355) of the overall IMPACT intent-to-treat (ITT) population. In the Japan subgroup, FF/UMEC/VI reduced the annual rate of on-treatment moderate/severe exacerbations by 15% (95% CI: -20, 40) versus FF/VI (compared with 15% [10, 20] in the ITT) and 36% (95% CI: 6, 57) versus UMEC/VI (compared with 25% [19, 30] in the ITT). FF/UMEC/VI reduced moderate/severe exacerbation risk (time-to-first), improved lung function and health status at Week 52 versus both dual therapies. These results were in the same direction and of a generally similar magnitude to those seen in the overall ITT population. No new safety signals were identified in the Japan subgroup compared with the ITT population. Pneumonia incidence was higher with FF/UMEC/VI and FF/VI versus UMEC/VI. Conclusion: These results highlight the favorable benefit-risk profile of FF/UMEC/VI single-inhaler triple therapy compared with FF/VI or UMEC/VI dual therapy in patients in Japan with symptomatic COPD and ≥1 exacerbation in the prior year.
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