PURPOSE:We aimed to assess long-term inhaled corticosteroid (ICS) risks in chronic obstructive pulmonary disease (COPD) management. METHODS:We extracted electronic health record data for individuals aged >45 years with COPD from a data repository. The prevalent cohort required a diagnosis of COPD any time during the observation period, and the inception cohort required a diagnosis of COPD made after entry into the database. A composite outcome of any new diagnosis of type 2 diabetes, cataracts, pneumonia, osteoporosis, or nontraumatic fracture; and recurrent event outcomes of repeated pneumonia or nontraumatic fracture were compared for long-term (>24 months) vs short-term (<4 months) ICS exposure. RESULTS:We assessed outcomes for 318,385 and 209,062 individuals in the prevalent and inception cohorts, respectively. The composite dichotomous outcome was significantly greater for long-term vs short-term ICS use for the prevalent (hazard ratio [HR] = 2.65; 95% CI, 2.62-2.68; P <.001) and inception (HR = 2.60; 95% CI, 2.56-2.64; P <.001) cohorts. For the inception cohort, the absolute risk difference of the composite outcome was 20.26% (29.41% minus 9.15%), with a number needed to harm of 5. Hazard ratios were significantly increased in the prevalent and inception cohorts for recurrent pneumonia (HR = 2.88; 95% CI, 2.62-3.16; P <.001 and HR = 2.85; 95% CI, 2.53-3.22; P <.001, respectively) and recurrent fracture (HR = 1.77; 95% CI, 1.42-2.21; P <.001 and HR = 1.57; 95% CI, 1.20-2.06; P <.001). CONCLUSIONS:Long-term ICS use for COPD is associated with significantly greater rates of the composite outcome of type 2 diabetes, cataracts, pneumonia, osteoporosis, and nontraumatic fracture; recurrent pneumonia; and recurrent fracture.

Purpose:Long-acting bronchodilator (LABD) therapy is recommended for maintenance treatment in most patients with chronic obstructive pulmonary disease (COPD). However, triple therapy (TT; dual LABDs + inhaled corticosteroid [ICS]) is often used as first-line maintenance treatment. The benefits of TT versus dual LABDs as first-line treatments are unknown, necessitating an evaluation of its effectiveness and costs versus non-ICS alternatives. Patients and Methods:This retrospective study assessed administrative claims of maintenance treatment-naive patients in the United States with COPD aged ≥40 years initiating single-inhaler fluticasone furoate+umeclidinium+vilanterol (FF+UMEC+VI) or tiotropium+olodaterol (TIO+OLO). Patients were propensity score-matched (1:1) and followed for up to 12 months. The primary outcome was time to first COPD exacerbation. Secondary outcomes included time to first pneumonia diagnosis, pneumonia-related hospitalization, healthcare resource utilization (HCRU), and costs. COPD exacerbation and pneumonia risk were assessed using Cox proportional hazards regression. Results:A total of 5,121 and 3,996 patients met the eligibility criteria for the FF+UMEC+VI and TIO+OLO groups, respectively. Outcomes were assessed among 2,951 matched pairs. The risk of moderate or severe COPD exacerbation was not significantly different between FF+UMEC+VI and TIO+OLO groups (hazard ratio [HR] [95% confidence interval {CI}]: 1.13 [0.99-1.29]; P=0.064). The risks of pneumonia (HR [95% CI]: 1.04 [0.85-1.27]; P=0.723) and pneumonia-related hospitalization (HR [95% CI]: 1.18 [0.78-1.79]; P=0.429) were also not significantly different between the groups. There were no significant differences in HCRU events or all-cause costs; however, FF+UMEC+VI initiators incurred greater COPD- and/or pneumonia-related pharmacy costs than TIO+OLO initiators (FF+UMEC+VI: $2,934 [$2,827-$3,041], TIO+OLO: $1,994 [$1,915-$2,073]; P<0.001). Conclusion:In maintenance treatment-naive patients, FF+UMEC+VI offered no reduction in COPD exacerbation risk over TIO+OLO and resulted in higher pharmacy costs related to COPD and/or pneumonia treatment. These results support treatment recommendations for LAMA+LABA as initial maintenance therapy. Trial Registration:ClinicalTrials.gov identifier - NCT05169424.

Objective: To assess the impact of the HealthPrize RespiPoints (TM) program on treatment adherence and persistence in adults with chronic obstructive pulmonary disease (COPD).Methods: In this retrospective cohort study, program participants and nonparticipants receiving tiotropium bromide (TIO) or TIO and olodaterol between 1 January 2015-31 March 2020 were propensity score matched (PSM), from the linked database of the HealthPrize patient list and IQVIA PharMetrics (R) Plus. Treatment adherence, persistence, healthcare resource utilization, and costs were compared. Multivariable logistic regression models assessed the odds of adherence (>= 80% proportion of days covered [PDC]), adjusted risk of discontinuation, and adjusted total healthcare costs.Results: Program participants (n = 262) demonstrated a 44% greater adherence during followup than nonparticipants (n = 262) (mean [standard deviation] PDC: 0.72 [0.27] vs 0.50 [0.36], p < 0.0001). Participants had higher odds of adherence vs nonparticipants (adjusted odds ratio: 2.51; 95% confidence interval: 1.72-3.66, p < 0.0001) and a lower percentage of participants discontinued their index medication (19.85% vs 33.59%, p = 0.0004). Fewer participants were hospitalized during follow-up (13.74% vs 17.56%, p = 0.23); adjusted total medical costs were 24% lower (p = 0.08). Higher pharmacy costs partially offset lower healthcare costs.Conclusions: Program participants showed improved COPD medication adherence and persistence compared to nonparticipants.

Introduction: Identifying factors influencing peak inspiratory flow (PIF) is essential for aerosol drug delivery in stable patients with chronic obstructive pulmonary disease. While a minimum PIF for dry powder inhalers (DPIs) is established, acute bronchodilator (BD) effects on PIF remain unknown. Materials and Methods: An inspiratory flow meter (In-Check™ DIAL) was used to measure PIF in stable patients during a 24-week observational cross-sectional study. Additionally, bronchodilator responsiveness (BDR) was determined using the In-Check DIAL device and spirometry. Patients received four puffs of albuterol, and pre- and post-BD PIF, forced expiratory volume in one second (FEV1), and forced vital capacity were measured. Sixty-three patients completed acute BDR data collection from July 31, 2019, to November 9, 2021. Primary endpoints were pre- and post-BD spirometry and PIF. Statistical analyses included PIF correlations with FEV1. BD change was assessed according to inhaler resistance and sex (subgroup analysis). Results: Median patient age was 64.8 years, 85.7% were non-Hispanic White, and 57.1% were female. The median increase in absolute PIF (In-Check DIAL) was 5.0 L/min, and the % PIF change was 8.9%. With albuterol, 57.1% experienced a PIF BD change >5.0%, whereas 49.2% experienced a change >10.0%. Similarly, 55.6% experienced an FEV1 BD change >5.0% and 28.6% had a >10.0% FEV1 BD change with albuterol. PIF was weakly correlated with FEV1 BD change (absolute; % PIF; r = 0.28 [p = 0.02]; r = 0.21 [p = 0.11]). Pre- and post-BD median PIF were 75.5 and 83.5 L/min for low-to-medium-resistance DPI and 45.0 and 52.0 L/min for high-resistance, respectively. The median increases in pre- and post-BD PIF were 9.0 L/min in males and 4.5 L/min in females. In contrast to when using the In-Check DIAL device, we observed no consistent bronchodilatory effects on PIF measured by spirometry. Conclusions: Using the In-Check DIAL device, ∼50% of patients experienced >10% PIF increase after acute BD, potentially enhancing medication lung deposition. Further research is required to understand PIF's impact on medication delivery. ClinicalTrials.gov Identifier: NCT04168775.

Background: We examined the effect of physical position on peak inspiratory flow (PIF) in patients with chronic obstructive pulmonary disease (COPD) using dry-powder inhalers (DPIs) with low-medium internal resistance (R2) and/or high internal resistance (R5). Methods: This prospective study in stable, ambulatory patients with spirometry-confirmed COPD evaluated the effect of 3 physical positions on maximal PIF achieved. Participants had PIFs of 30-90L/min (R5) or 60-90L/min (R2 DPIs) using the In-Check (TM) DIAL. PIF was measured in triplicate randomly in 3 positions that patients might be in while using their inhaler (standing, sitting, and semi-upright [supine position with the head of the bed at 45 degrees, neck flexed forward]) against prescribed DPI resistance (R2/R5/both). Correlations between PIF and percentage decline in PIF between positions and differences in participant characteristics with >10% versus <= 10% PIF decline standing to semi-upright were calculated. Results: A total of 76 participants (mean age, 65.2 years) had positional measurements; 59% reported seated DPI use at home. The mean (standard deviation) PIF standing, sitting, and semi-upright was 80.7 (13.4), 77.8 (14.3), and 74.0 (14.5) L/min, respectively, for R2 and 51.1 (9.52), 48.6 (9.84), and 45.8 (7.69) L/min, respectively, for R5 DPIs. PIF semi-upright was significantly lower than sitting and standing (R2; P < 0.0001) and standing (R5; P= 0.002). Approximately half of the participants had >10% decline in PIF from standing to semi-upright. Patient characteristics exceeding the 0.10 absolute standardized difference threshold with the decline in PIF for both the R2 and R5 DPIs were waist-to-hip ratio, modified Medical Research Council dyspnea score, and postbronchodilator percentage predicted forced vital capacity and PIF by spirometry. Conclusions: PIF was significantly affected by physical position regardless of DPI resistance. PIF was highest when standing and lowest when semi-upright. We recommend that patients with COPD stand while using an R2 or R5 DPI. Where unfeasible, the position should be sitting rather than semi-upright. ClinicalTrials.gov identifier NCT04168775.

PURPOSE: Prompt and effective management with dual bronchodilation after the initial diagnosis of chronic obstructive pulmonary disease (COPD) is critical to preserve lung function and prevent exacerbations.This large, real-world study assessed pharmacologic treatment patterns of newly diagnosed COPD patients over a 4-year period. METHODS:This was a retrospective, noninterventional study conducted in the USA that used de-identified administrative claims data (Inovalon database, including commercial, Medicaid, and Medicare Advantage-insured individuals; January 01, 2015ÀDecember 31, 2021).The study assessed pharmacologic treatment patterns over 4 years in newly diagnosed patients with COPD (aged $40 years; 2+ medical claims).Sociodemographic and clinical characteristics were determined.Descriptive statistics were reported for study variables. RESULTS:The study included 238,158 newly diagnosed patients with COPD (mean age: 63.8 years; female: 52.9%).At initial diagnosis (within 30 days), only 13.8% (n¼32,981) of the total study population received long-acting maintenance treatment and 23.7% (n¼56,438) received short-acting treatment.In the follow up period after diagnosis, 22.3% (n¼53,187) of patients received long-acting maintenance treatment (mean time to first prescription 1.30 years [SD: 1.10]) and 33.4% (n¼79,439) received shortacting treatment (mean time to first prescription: 1.19 years [SD: 1.02]).A total of 38.8% of the total study population (n¼92,342) remained untreated with any therapy during the 4-year follow-up period.Most patients (n/N) received long-acting b2-agonist (LABA)/inhaled corticosteroids (ICS) as their initial treatment (62.0%[20,459/32,981]) at diagnosis, and ICS/LABA continued to be the most common initial treatment during the 4-year period (63.7% [17,287/27,141] at year 1; 58.8% [3,475/5,906] at year 4).As initial treatment, long-acting muscarinic antagonist (LAMA) monotherapy decreased from 30.3% [9,983/32,981] at diagnosis to 25.5% [6,929/27,141] and 18.6% [1,098/5,906] at years 1 and 4, respectively, whereas LAMA/LABA therapy increased from 6. 4% [2,123/32,981] at diagnosis to 9.1% [2,473/27,141] and 15.9% [937/5,906] at years 1 and 4, respectively.LABA monotherapy was prescribed to 1.3% [415/32,981], 1.5% [416/27,141], and 1.1% [66/5,906] of patients, and LAMA/LABA/ICS therapy to <0.01%[1/32,981], 0.1% [36/27,141], and 5.6% [330/5,906] of patients, at diagnosis, years 1, and 4, respectively.CONCLUSIONS: Many newly diagnosed COPD patients do not receive long-acting maintenance treatment.In this analysis, 4 years after diagnosis, 63.8% of patients remained untreated or received only short-acting medications.Bronchodilator treatment, a guideline-recommended initial pharmacological treatment, was prescribed to few patients at or within 30 days of diagnosis.CLINICAL IMPLICATIONS: Randomized controlled trials and real-world evidence studies have shown the benefit of providing maintenance COPD pharmacotherapy from time of diagnosis throughout the course of the disease.This retrospective study provides evidence that many patients remain untreated post-diagnosis and treatment is not consistent with guidelines.Changes in clinical practice should improve clinical outcomes which would benefit both COPD patients and the healthcare system.

Background: It is unclear whether persistent inhaled steroid exposure in chronic obstructive pulmonary disease (COPD) patients before coronavirus disease 2019 (COVID-19) is associated with hospitalization risk. Objective: Our objective was to examine the association between persistent steroid exposure and COVID-19-related hospitalization risk in COPD patients. Study Design and Methods: This retrospective cohort study used electronic health records from the Kaiser Permanente Northern California health care system (February 2, 2020, to September 30, 2020) for patients aged >= 40 years with COPD and a positive polymerase chain reaction test result for COVID-19. Primary exposure was persistent oral and/or inhaled steroid exposure defined as >= 6 months of prescriptions filled in the year before the COVID-19 diagnosis. Multivariable logistic regression was performed for the primary outcome of COVID-19-related hospitalization or death/hospice referral. Steroid exposure in the month before a COVID-19 diagnosis was a covariate. Results: Of >4.3 million adults, 697 had COVID-19 and COPD, of whom 270 (38.7%) had COVID-19-related hospitalizations. Overall, 538 (77.2%) were neither exposed to steroids in the month before COVID-19 diagnosis nor persistently exposed; 53 (7.6%) were exposed in the month before but not persistently; 23 (3.3%) were exposed persistently but not in the month before; and 83 (11.9%) were exposed both persistently and in the month before. Adjusting for all confounders including steroid use in the month before, the odds ratio for hospitalization was 0.77 (95% confidence interval 0.41-1.46) for patients persistently exposed to steroids before a COVID-19 diagnosis. Interpretation: No association was observed between persistent steroid exposure and the risk of COVID-19-related hospitalization in COPD patients.

Background:ATS and GOLD guidelines recommend treating low-exacerbation risk COPD patients with dual (LAMA/LABA) agents and reserving triple therapy (TT; LAMA/LABA and inhaled corticosteroids [ICS]) for severe cases with higher-exacerbation risk. However, TT often is prescribed across the COPD spectrum. This study compared COPD exacerbations, pneumonia diagnosis, healthcare resource utilization, and costs for patients initiating tiotropium bromide/olodaterol (TIO/OLO) and a TT, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI), stratified by exacerbation history. Methods:COPD patients who initiated TIO/OLO or FF/UMEC/VI between 06/01/2015-11/30/2019 (index date=first pharmacy fill-date with ≥30 consecutive treatment days) were identified from the Optum Research Database. Patients were ≥40 years old and continuously enrolled for 12 months during the baseline period and ≥30 days during follow-up. Patients were stratified into GOLD A/B (0-1 baseline non-hospitalized exacerbation), No exacerbation (subset of GOLD A/B), and GOLD C/D (≥2 non-hospitalized and/or ≥1 hospitalized baseline exacerbation). Baseline characteristics were balanced with propensity score matching (1:1). Adjusted risks of exacerbation, pneumonia diagnosis, and COPD and/or pneumonia-related utilization and costs were evaluated. Results:Adjusted exacerbation risk was similar in GOLD A/B and No exacerbation subgroups, and lower in GOLD C/D for FF/UMEC/VI versus TIO/OLO initiators (hazard ratio: 0.87; 95% CI: 0.78, 0.98, p=0.020). Adjusted pneumonia risk was similar between cohorts across the GOLD subgroups. Adjusted COPD and/or pneumonia-related population annualized pharmacy costs were significantly higher for FF/UMEC/VI versus TIO/OLO initiators across subgroups, p<0.001. Adjusted COPD and/or pneumonia-related population annualized total healthcare costs were significantly higher for FF/UMEC/VI versus TIO/OLO initiators in the GOLD A/B and No exacerbation, subgroups, p<0.001 (cost ratio [95% CI]: 1.25 [1.13, 1.38] and 1.21 [1.09, 1.36], respectively), but similar in the GOLD C/D subgroup. Conclusion:These real-world results support ATS and GOLD recommendations for treating low-exacerbation risk COPD patients with dual bronchodilators and TT for more severe, higher-exacerbation risk COPD patients.

Background and objective: Patients with chronic obstructive pulmonary disease (COPD) may have worse coronavirus disease-2019 (COVID-19)-related outcomes. We compared COVID-19 hospitalization risk in patients with and without COPD. Methods: This retrospective cohort study included patients >= 40 years, SARS-CoV-2 positive, and with Kaiser Permanente Northern California membership >= 1 year before COVID-19 diagnosis (electronic health records and claims data). COVID-19-related hospitalization risk was assessed by sequentially adjusted logistic regression models and stratified by disease severity. Secondary outcome was death/hospice referral after COVID-19. Results and discussion: Of 19,558 COVID-19 patients, 697 (3.6%) had COPD. Compared with patients without COPD, COPD patients were older (median age: 69 vs 53 years); had higher Elixhauser Comorbidity Index (5 vs 0) and more median baseline outpatient (8 vs 4), emergency department (2 vs 1), and inpatient (2 vs 1) encounters. Unadjusted analyses showed increased odds of hospitalization with COPD (odds ratio [OR]: 3.93; 95% confidence interval [CI]: 3.40-4.60). After full risk adjustment, there were no differences in odds of hospitalization (OR: 1.14, 95% CI: 0.93-1.40) or death/hospice referral (OR: 0.96, 95% CI: 0.72-1.27) between patients with and without COPD. Primary/secondary outcomes did not differ by COPD severity, except for higher odds of hospitalization in COPD patients requiring supplemental oxygen versus those without COPD (OR: 1.84, 95% CI: 1.02-3.33). Conclusions: Except for hospitalization among patients using supplemental oxygen, no differences in odds of hospitalization or death/hospice referral were observed in the COVID-19 patient sample depending on whether they had COPD.

Background: In patients with COPD, inhalation ability should be assessed when considering inhaler choice. To evaluate whether the soft mist inhaler (SMI) is suitable for COPD patients irrespective of inhalation ability, the TRONARTO study investigated the efficacy of dual long-acting bronchodilator therapy delivered via the Respimat & REG; SMI on lung function in patients with COPD stratified by inhalation ability. Tiotropium/olodaterol delivered via the SMI was effective both in patients with peak inspiratory flow (PIF) <60 L/min and PIF & GE;60 L/min, measured against medium-low resistance.Methods: This congress compilation summarizes post hoc analyses from the TRONARTO study presented at the annual American Thoracic Society 2022 and European Respiratory Society 2022 meetings. These analyses evaluated PIF in over 200 patients, with PIF measurements taken daily at home for 4 weeks, and in the clinic at baseline, Weeks 2 and 4.Results: Overall, 57.9% of patients had a PIF range (difference between lowest and highest PIF measurements) <20 L/min (12.4% of patients had PIF range <10 L/min). At-home PIF range decreased over the study period, suggesting that inhaler training/repeated PIF measurements may help to make patients' inspiratory effort more consistent. Some patient characteristics correlated with lower PIF (female gender, shorter stature, more severe disease, worse airflow obstruction) and lower PIF range (more severe disease). PIF measurements differed between medium-low and high-resistance settings, highlighting the importance of measuring PIF at the resistance of a patient's inhaler. PIF correlated poorly with spirometry measurements.Conclusion: As indicated in COPD management guidelines, choice of inhaler is essential to optimize pharmacologic therapies for COPD. Poor inspiratory ability should be viewed as a treatable trait that can help to inform inhaler choice. Inhaler training and consideration of PIF (if patients use a dry powder inhaler) can reduce patient-to-inhaler mismatch, with potential consequences for health status and exacerbation risk.

Background: Based on current clinical guidelines, long-acting β2-agonists (LABA) are frequently prescribed before long-acting muscarinic antagonists (LAMA) as an add-on to inhaled corticosteroids (ICS) in uncontrolled asthma. However, there is insufficient real-world evidence that supports this therapeutic approach. Objective: The objective was to compare asthma exacerbations and healthcare resource utilization in patients with asthma using the LAMA tiotropium bromide (Tio) or a LABA as an add-on to ICS (ICS + Tio or ICS/LABA) in a real-world setting. Methods: This retrospective, observational study included patients aged ≥12 years with asthma diagnoses identified in a U.S. longitudinal claims database (October 2015 to August 2020). The ICS + Tio and ICS/LABA cohorts were 1:2 propensity score matched for baseline variables. Outcomes were compared in the postmatched cohorts, and the risk of exacerbation was evaluated by using Kaplan-Meier curves. Results: After propensity score matching, there were 633 and 1266 patients in the ICS + Tio and ICS/LABA cohorts, respectively. The proportion of patients who experienced a severe or a moderate-or-severe exacerbation during follow-up was similar between the ICS + Tio versus ICS/LABA cohorts (4% versus 3%, p = 0.472, and 50% versus 45%, p = 0.050, respectively). The mean time to first severe (ICS + Tio 43.8 days versus ICS/LABA 49.4 days, p = 0.758) and moderate-or-severe exacerbation (ICS + Tio 65.8 days versus ICS/LABA 58.9 days, p = 0.474) was not statistically different between cohorts. The treatments had no effect on the risk of severe exacerbation, although it was 36% lower in ICS + Tio users than in ICS/LABA users (hazard ratio 0.64 [95% confidence interval, 0.22-1.84]). All-cause and asthma-related average monthly healthcare resource utilization were comparable between the treatments for hospitalizations and emergency department visits but were significantly greater in the ICS + Tio cohort than in the ICS/LABA cohort for asthma-related outpatient visits (p < 0.0001). Conclusion: This study provides real-world evidence that ICS + Tio may be a valid alternative when ICS/LABA cannot be used as first-line treatment for asthma maintenance therapy.

BACKGROUND: Clinical practice guidelines recommend dual long-acting muscarinic antagonists (LAMAs)/long-acting β2agonists (LABAs) as maintenance therapy in patients with chronic obstructive pulmonary disease (COPD) and dyspnea or exercise intolerance. Escalation to triple therapy (TT) (LAMA/LABA/inhaled corticosteroid) is conditionally recommended for patients with continued exacerbations on dual LAMA/LABA therapy. Despite this guidance, TT use is widespread across COPD severities, which could impact clinical and economic outcomes. OBJECTIVE: To compare COPD exacerbations, pneumonia events, and disease-related and all-cause health care resource utilization and costs (in 2020 US dollars) in patients initiating fixed-dose combinations of either LAMA/LABA (tiotropium/olodaterol [TIO + OLO]) or TT (fluticasone furoate/umeclidinium/vilanterol [FF + UMEC + VI]). METHODS: This retrospective observational study of administrative claims included patients with COPD aged 40 years or older initiating TIO + OLO or FF + UMEC + VI from June 2015 to November 2019. TIO + OLO and FF + UMEC + VI cohorts in the overall and maintenance-naive populations were 1:1 propensity score matched on baseline demographics, comorbidities, COPD medications, health care resource utilization, and costs. Multivariable regression compared clinical and economic outcomes up to 12 months in FF + UMEC + VI vs TIO + OLO postmatched cohorts. RESULTS: After matching, there were 5,658 and 3,025 pairs in the overall and maintenance-naive populations, respectively. In the overall population, the risk of any (moderate or severe) exacerbation was 7% lower in FF + UMEC + VI vs TIO + OLO initiators (adjusted hazard ratio [aHR] = 0.93; 95% CI = 0.86-1.0; P = 0.047). There was no difference in the adjusted risk of any exacerbation in the maintenance-naive population (aHR = 0.99; 95% CI = 0.88-1.10). Pneumonia risk was not statistically different between cohorts in the overall (aHR = 1.12; 95% CI = 0.98-1.27) and maintenance-naive (aHR = 1.13; 95% CI = 0.95-1.36) populations. COPD- and/or pneumonia-related adjusted total annualized costs (95% CI) were significantly greater for FF + UMEC + VI vs TIO + OLO in the overall ($17,633 [16,661-18,604] vs $14,558 [13,709-15,407]; P < 0.001; differences [% of relative increase] = $3,075 [21.1%]) and maintenancenaive ($19,032 [17,466-20,598] vs $15,004 [13,786-16,223]; P < 0.001; $4,028 [26.8%]) populations, with significantly higher pharmacy costs with FF + UMEC + VI (overall: $6,567 [6,503-6,632] vs $4,729 [4,676-4,783]; P < 0.001; $1,838 [38.9%]; maintenance-naive: $6,642 [6,560-6,724] vs $4,750 [4,676-4,825]; P < 0.001; $1,892 [39.8%]). CONCLUSIONS: A lower risk of exacerbation was observed with FF + UMEC + VI vs TIO + OLO in the overall population but not among the maintenance-naive population. Patients with COPD initiating TIO + OLO had lower annualized costs than FF + UMEC + VI initiators in the overall and maintenance-naive populations. Thus, in the maintenance-naive population, initiation with dual LAMA/LABA therapy per practice guidelines can improve real-world economic outcomes. Study registration number: ClinicalTrials.gov (identifier: NCT05127304). DISCLOSURES: The study was funded by Boehringer Ingelheim Pharmaceuticals, Inc (BIPI). To ensure independent interpretation of clinical study results and enable authors to fulfill their role and obligations under the ICMJE criteria, BIPI grants all external authors access to relevant clinical study data. In adherence with the BIPI Policy on Transparency and Publication of Clinical Study Data, scientific and medical researchers can request access to clinical study data after publication of the primary manuscript in a peer-reviewed journal, regulatory activities are complete and other criteria are met. Dr Sethi has received honoraria/fees for consulting/speaking from Astra-Zeneca, BIPI, and GlaxoSmithKline. He has received consulting fees for serving on data safety monitoring boards from Nuvaira and Pulmotect. He has received consulting fees from Apellis and Aerogen. His institution has received research funds for his participation in clinical trials from Regeneron and AstraZeneca. Ms Palli was an employee of BIPI at the time the study was conducted. Drs Clark and Shaikh are employees of BIPI. Ms Buysman and Mr Sargent are employees and Dr Bengtson was an employee of Optum, which was contracted by BIPI to conduct this study. Dr Ferguson reports grants and personal fees from Boehringer Ingelheim during the conduct of the study; grants from Novartis, Altavant, and Knopp; grants and personal fees from AstraZeneca, Verona, Theravance, Teva, and GlaxoSmithKline; and personal fees from Galderma, Orpheris, Dev.Pro, Syneos, and Ionis outside the submitted work. He was a paid consultant for BIPI for this study. The authors received no direct compensation related to the development of the manuscript. BIPI was given the opportunity to review the manuscript for medical and scientific accuracy as well as intellectual property considerations.

Background:Patients with chronic obstructive pulmonary disease (COPD) can have low peak inspiratory flow (PIF), especially after hospitalization for acute exacerbation of COPD (AECOPD).Purpose:To characterize patients hospitalized for AECOPD, and to assess the prevalence of low PIF, changes in PIF after hospitalization, and the association of low PIF with healthcare resource utilization (HRU) outcomes.Patients and Methods:A retrospective cohort study was conducted using electronic health record data of hospitalized COPD patients in the Wake Forest Baptist Health system (01/01/2017 through 06/30/2020). Patients with a first eligible AECOPD hospitalization (index hospitalization) who were discharged before 05/31/2020 were included. PIF was measured using the In-Check DIAL™ at both medium-low resistance (R-2) and high resistance (R-5) during the index hospitalization. For R-2 and R-5, PIF was divided into low PIF (< 60 L/min; < 30 L/min) and high PIF (≥ 60 L/min; ≥ 30 L/min) groups. The primary outcome was the prevalence of low PIF. The stability of PIF after hospitalization was described. Adjusted regression models evaluated associations between low PIF and subsequent 30-day readmissions, 90-day readmissions, and HRU outcomes, including hospitalizations, emergency department visits, inpatient days, and intensive care unit (ICU) days.Results:In total, 743 patients with PIF measured at R-2 and R-5 during a AECOPD hospitalization were included. The prevalence of low PIF was 56.9% at R-2 and 14.7% at R-5. PIF values were relatively stable after hospitalization. Adjusted analyses showed significant increases in HRU (all-cause hospitalizations [31%], COPD hospitalizations [33%], COPD inpatient days [46%], and COPD ICU days [24%]) during the follow-up period among patients with low PIF (< 60 L/min) at R-2. The 30- and 90-day readmission risks were similar between patients with low PIF and high PIF.Conclusion:Low PIF is common among patients hospitalized for AECOPD, relatively stable after hospital discharge, and associated with increased HRU.

Abstract Introduction Hyperbaricoxygen therapy (HBOT) is breathing100% oxygen in pressurised chamber. This therapy ensures quick oxygen delivery to the bloodstream. In patients with severe COVID-19 pneumonia, progressive hypoxemia occurs. Oxygen therapy hasa significant role in its management. Aim of the study The objective was to study the efficacy of hyperbaric oxygen therapy (HBOT) as adjuvant therapy for reducing the requirement of additional oxygen supplementationin patients with moderate to severe ARDS diagnosed with COVID-19. Methods A single-centre prospective pilot cohort study was conducted ata tertiary care hospital from December 2020 to February 2021 over two months. Fifty patients with COVID-19 needingoxygen, satisfying the selection criteria, were included. Hyperbaricoxygen therapy wasgiven to all patients. The patient received30-45 minutes of hyperbaric oxygen with 15 minutes of pressurizing and depressurizing at 2.0 atmosphere absolute (ATA) with or without airbrakesas per the critical care team. Oxygen requirement, PaO2, andcondition at discharge were considered as primary outcome variables. Results Among the 50 participants studied, the mean age was 53.64±13.26 years. Out of 50 participants, 49(98.00%) had PaO2≤80 mmHg, and one (2.00%) had >80 PaO2. All the participants 50(100%) had PaO2 as 90 mmHg after three sittings. Conclusion This studyshows promising results in using HBOT to overcome respiratory failure in COVID-19. HBOT reduced the need for oxygen by improving the oxygen saturation levels.

Background: The TRONARTO study demonstrated that, irrespective of PIF, moderate-to-severe COPD patients treated with tiotropium/olodaterol delivered via Respimat™ had significant lung function improvements versus placebo. Cross-sectional data show that age and female sex are associated with suboptimal PIF, but there are no data on whether patient characteristics influence PIF variability over time. Methods: In TRONARTO, a 4-week study, patients with moderate-to-severe COPD were stratified by PIF. Min/max at-home daily PIF measurements were identified for each patient, and quartiles based on PIF ranges were tested for trend against baseline (BL) characteristics including age, sex, stature and disease severity (GOLD stage 2 vs 3). Weekly PIF ranges (per patient, per study week) and weekly population mean and standard error (SE) were calculated. The difference between in-clinic (BL, wk2 and wk4) and at-home PIF was compared, overall and by PIF strata. Results: Patients with more severe disease had lower PIF variability than those with moderate disease (GOLD 3 vs 2; p=0.01), but no other BL characteristic showed a trend with variability (n=213). PIF variance showed a significant decline with study week (SE 0.50–0.39L/min; p=0.0001). The difference between PIF in clinic vs at home decreased between clinic visits: BL, -2.4, wk2, -0.3, wk4, +0.8L/min (overall population). At BL, the <60L/min PIF stratum showed the largest difference between in-clinic and at-home measurements (-3.9L/min). Conclusion: Age, sex, and stature did not show a significant trend with PIF variability. PIF variability, in both daily at-home measurements, and between in-clinic and at-home measurements, reduced over 4 weeks.