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. 2024 Mar 22:2024:8034923.
doi: 10.1155/2024/8034923. eCollection 2024.

Clinical Burden of Chronic Obstructive Pulmonary Disease in Patients with Suboptimal Peak Inspiratory Flow

Jill A Ohar  1 , Donald A Mahler  2   3 , Gabrielle N Davis  4 , David A Lombardi  4 , Edmund J Moran  4 , Glenn D Crater  4
Affiliations

Clinical Burden of Chronic Obstructive Pulmonary Disease in Patients with Suboptimal Peak Inspiratory Flow

Jill A Ohar et al. Can Respir J. .

Abstract

Introduction: Many patients with chronic obstructive pulmonary disease (COPD) may derive inadequate benefit from dry powder inhalers (DPIs) because of suboptimal peak inspiratory flow (sPIF).

Objectives: To assess the clinical burden of COPD by characterizing the clinical characteristics of participants with sPIF against medium-low resistance DPIs versus those with optimal PIF (oPIF) from two phase 3 clinical trials.

Methods: Baseline data were collected from two randomized, controlled, phase 3 trials (NCT03095456; NCT02518139) in participants with moderate-to-severe COPD. oPIF (60 L/min) against the medium-low resistance DPIs was used as the threshold for defining the PIF subgroups (<60 L/min (sPIF) vs ≥60 L/min (oPIF)).

Results: Most participants included in this analysis were White (92%) and male (63%); the mean (range) age was 65 (43-87) years. Participants with sPIF had significantly greater dyspnea than those with oPIF as measured using the modified Medical Research Council scoring (mean (95% CI): 2.1 (2.0-2.2) vs 1.6 (1.4-1.7); P < 0.001) and baseline dyspnea index (mean (95% CI): 5.1 (4.9-5.4) vs 6.1 (5.8-6.3); P < 0.001). Based on COPD Assessment Test scores, participants with sPIF had a higher COPD symptom burden than those with oPIF (mean (95% CI): 21.5 (19.7-23.3) vs 19.5 (18.6-20.4); P = 0.05).

Conclusion: In these trials, participants with COPD who had sPIF against the medium-low resistance DPIs had more dyspnea and worse health status than those with oPIF. These results demonstrate that sPIF is associated with a higher clinical burden as measured by patient-reported outcomes.

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Conflict of interest statement

JAO has served on advisory boards for AstraZeneca, Boehringer Ingelheim, GSK, Mylan Inc., Reckitt Benckiser, Sunovion Pharmaceuticals, and Theravance Biopharma US, Inc. DAM has served on advisory boards for AstraZeneca, Boehringer Ingelheim, GSK, Mylan, Sunovion Pharmaceuticals, Theravance Biopharma US, Inc., and Teva and is on the speaker's bureau for AstraZeneca, Boehringer Ingelheim, and Teva Pharmaceuticals. GND is an employee of Theravance Biopharma US, Inc. DAL is a contract employee of Theravance Biopharma US, Inc. EJM is an employee of Theravance Biopharma US, Inc. GDC was an employee of Theravance Biopharma US, Inc., at the time these trials were conducted.

Figures

Figure 1
Figure 1
Mean (a) mMRC score and (b) BDI in participants with oPIF and sPIF against the medium-low resistance DPIs. BDI = baseline dyspnea index; CI = confidence interval; DPI = dry powder inhaler; mMRC = modified Medical Research Council; oPIF = optimal PIF; PIF = peak inspiratory flow; sPIF = suboptimal PIF.
Figure 2
Figure 2
Mean CAT scores in participants with oPIF and sPIF against the medium-low resistance DPIs. CAT = COPD assessment test; CI = confidence interval; DPI = dry powder inhaler; oPIF = optimal PIF; PIF = peak inspiratory flow; sPIF = suboptimal PIF.
Figure 3
Figure 3
Mean percent predicted (a) FEV1 and (b) FVC in participants with oPIF and sPIF against the medium-low resistance DPIs. CI = confidence interval; FEV1 = forced expiratory volume in 1 second; FVC = forced vital capacity; IPR = ipratropium; oPIF = optimal PIF; PIF = peak inspiratory flow; sPIF = suboptimal PIF.
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