Allergy and Airway |

Effect of Budesonide/Formoterol or Formoterol on Lung Function and Patient-Centered Outcomes: 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):31A. doi:10.1378/chest.1990173
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SESSION TITLE: COPD Diagnosis and Evaluation Posters I

SESSION TYPE: Original Investigation Poster

PRESENTED ON: Wednesday, October 29, 2014 at 01:30 PM - 02:30 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) on lung function; rescue medication (RM) use; breathlessness, cough, and sputum score (BCSS); dyspnea score; and St. George’s Respiratory Questionnaire (SGRQ) total score.

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) with ≥1 COPD exacerbation in the past year were stratified by moderate AL (forced expiratory volume in 1 second [FEV1] % predicted ≥50%) and severe/very severe AL (FEV1 % predicted <50%) and assigned to twice-daily BUD/FM via pressurized metered-dose inhaler 320/9 μg (n = 197, moderate AL; n = 975, severe/very severe AL) or FM via dry-powder inhaler 9 μg (n = 211, moderate AL; n = 963, severe/very severe AL). Changes from baseline to treatment period mean in predose FEV1 (L), RM use (inhalations/d), BCSS, dyspnea score, and change to end of treatment in SGRQ scores are reported. For BCSS, dyspnea, and SRGQ, higher scores indicate greater severity/impairment.

RESULTS: Increases in predose FEV1 were greater in the BUD/FM vs FM group (0.13 vs 0.06 L, moderate AL; 0.07 vs 0.04 L, severe/very severe AL). Decrease in RM use was greater with BUD/FM vs FM (−1.33 vs −1.08, moderate AL; −1.13 vs -0.60, severe/very severe AL). BCSS improvements with BUD/FM were less than FM in moderate AL (−0.95 vs −1.13) but greater in severe/very severe AL patients (−0.76 vs −0.60). Dyspnea improvements were equal with BUD/FM vs FM in moderate AL patients (−0.44) but greater for BUD/FM vs FM in severe/very severe AL patients (−0.33 vs −0.23). Mean SGRQ improvements were also greater with BUD/FM vs FM (−6.88 vs −6.10, moderate AL; −5.13 vs −2.96, severe/very severe AL).

CONCLUSIONS: A robust response to BUD/FM vs FM was observed for all outcomes in all AL patients. Differential improvements with BUD/FM relative to FM alone were numerically better in moderate vs severe/very severe AL patients for lung function and more evident for severe/very severe vs moderate AL patients for patient-centered outcomes.

CLINICAL IMPLICATIONS: Patients with both moderate and severe/very severe AL benefit from BUD/FM vs FM alone. The relative magnitude of improvement with BUD/FM vs FM alone in lung function and patient-centered outcomes differs depending on AL severity. 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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