Allergy and Airway |

Effect of Budesonide/Formoterol or Formoterol on Exacerbation Rates (Including and Excluding Antibiotics) and Responder Analysis: Pooled Analysis of Chronic Obstructive Pulmonary Disease Patients With Moderate vs Severe/Very Severe Airflow Limitation FREE TO VIEW

Donald Tashkin; Stephen Rennard; Frank Trudo
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University of California Los Angeles, Los Angeles, CA

Chest. 2014;146(4_MeetingAbstracts):74A. doi:10.1378/chest.1990182
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SESSION TYPE: Original Investigation Slide

PRESENTED ON: Sunday, October 26, 2014 at 01:30 PM - 03:00 PM

PURPOSE: To assess the efficacy of budesonide/formoterol (BUD/FM) or FM in chronic obstructive pulmonary disease (COPD) patients with moderate vs severe/very severe airflow limitation (AL), with regard to exacerbation rates (defined as COPD worsening requiring treatment with oral corticosteroids [OCS] and/or hospitalization [HOSP], including or excluding antibiotics [ABX]), and the percentage of patients with clinically meaningful improvements in lung function.

METHODS: In a post-hoc analysis of pooled data from 3 double-blind, randomized studies, (A: 12-month; NCT00206167; B: 12-month, NCT00419744; and C: 6-month, NCT00206154), COPD patients (aged ≥40 years) who had ≥1 COPD exacerbation in the past year were stratified as having moderate AL (forced expiratory volume in 1 second [FEV1] % predicted ≥50%) and severe/very severe AL (FEV1 % predicted <50%). Treatments were twice daily: BUD/FM via pressurized metered-dose inhaler 320/9 μg (n = 197, moderate AL; n = 975, severe/very severe AL) and FM via dry-powder inhaler 9 μg (n = 211, moderate AL; n = 963, severe/very severe AL). Exacerbations per patient-treatment year and responders with ≥100-mL improvement in predose FEV1 are reported.

RESULTS: The lowest rate of OCS/HOSP exacerbations excluding ABX occurred with BUD/FM vs FM alone (moderate AL, 0.4 vs 0.7 per patient-treatment year [P = .0013]; severe/very severe AL, 0.8 vs 1.0 [P < .0001]). OCS/HOSP exacerbations including ABX were also lowest with BUD/FM vs FM (moderate AL, 0.5 vs 0.8 [P = .0034]; severe/very severe AL, 0.9 vs 1.2 [P < .0001]). The percentages of patients who met responder criteria for ≥100-mL predose FEV1 improvement were greater with BUD/FM vs FM alone in moderate AL (46.9% vs 38.6%) and severe/very severe AL patients (33.7% vs 28.6%).

CONCLUSIONS: Exacerbation rates (OCS/HOSP), including or excluding ABX, in COPD patients were reduced with BUD/FM vs FM alone irrespective of AL severity and despite an overall lower exacerbation rate in moderate vs severe/very severe AL. Overall, a greater percentage of patients receiving BUD/FM met responder criteria for ≥100-mL improvement in predose FEV1 vs FM alone and was more pronounced in moderate vs severe/very severe AL.

CLINICAL IMPLICATIONS: COPD patients with moderate and severe/very severe airflow limitation benefit from BUD/FM vs FM alone, with improvements in lung function and lower exacerbation rates. Supported by AstraZeneca LP.

DISCLOSURE: Donald Tashkin: Consultant fee, speaker bureau, advisory committee, etc.: AstraZeneca – speaker, advisory board; Sunovion – advisory board; Theravance – consultant; Pearl – advisory board; Boehringer-Ingelheim – speaker; Forest – speaker, Grant monies (from industry related sources): Sunovion – research grant; Pearl – research grant; GlaxoSmithKline – research grant Stephen Rennard: Consultant fee, speaker bureau, advisory committee, etc.: Consultations: GlaxoSmith-Kline, Boehringer Ingelheim, Forestweb program, AstraZeneca, Chiesi, Takeda, Regeneron, Pearl, CIPLA, CSA, ABIM, Merck, Medimmune, Synapse, Nycomed, DaiIchio Sankyo, Novartis, J&J, Quadrant, GersonLehman, Able Assoc, CSL Behring, Decision Resources, FirstWord, Gilead, Guidepoint Global, Pulmatrix, Saatchi and Saatchi, Schlesinger Assoc, Cory Paety, Frankel group, Medical Knowleged, Pro Ed Comm, LEK Consulting, Consultant fee, speaker bureau, advisory committee, etc.: Speaking Fees: AstraZeneca, CME Incite, CTS Carmel, Nycomed Frank Trudo: Employee: Employee of AstraZeneca LP, Shareholder: Shareholder of AstraZeneca stock

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