Obstructive Lung Diseases |

Efficacy Outcomes With Budesonide/Formoterol Pressurized Metered-Dose Inhaler (BUD/FM pMDI) According to Global Initiative for Chronic Obstructive Lung Disease (GOLD) Classification at Baseline in Patients With Chronic Obstructive Pulmonary Disease (COPD) FREE TO VIEW

Donald Tashkin, MD; Stephen Rennard, MD; Tom Uryniak, MS; Ubaldo Martin, MD; Frank Trudo, MD
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University of California Los Angeles, Los Angeles, CA

Chest. 2013;144(4_MeetingAbstracts):729A. doi:10.1378/chest.1703149
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SESSION TITLE: COPD Treatment Posters

SESSION TYPE: Original Investigation Poster

PRESENTED ON: Wednesday, October 30, 2013 at 01:30 PM - 02:30 PM

PURPOSE: This analysis evaluates long-term COPD treatment response according to baseline COPD severity category using the 2011 GOLD assessment approach (combination of pulmonary function, symptoms, and/or exacerbation history) versus airflow limitation severity (GOLD grade) alone.

METHODS: A post hoc analysis from a 12-month, randomized, double-blind, multicenter study (NCT00206167;Drugs.2009;699:549-65;N=1964) in moderate-very severe COPD patients aged ≥40 years with a Modified Medical Research Council score ≥2 and ≥1 COPD exacerbation within the previous year. Previous inhaled corticosteroid therapy, allowed during a 2-week run-in period, was discontinued at randomization. Efficacy outcomes were stratified by: 1)GOLD grade based on screening postbronchodilator forced expiratory volume in 1 second (FEV1) % predicted values (Grade 2: 50-<80% predicted, Grade 3: 30-<50% predicted, Grade 4: <30% predicted) in patients with 1 exacerbation within the past 12 months and 2)combined GOLD assessment category (category B: GOLD grade 2 and/or 1 exacerbation within the past 12 months; category D: GOLD grades 3-4 and/or ≥2 exacerbations within the past 12 months). Data from 3 of the 4 randomized treatment arms in the study were included: twice-daily BUD/FM pMDI 320/9 μg, twice-daily formoterol dry powder inhaler (FM DPI) 9 μg, and placebo.

RESULTS: Treatment outcomes (predose FEV1, morning/evening peak expiratory flow [PEF], rescue medication use, dyspnea score, and St. George’s Respiratory Questionnaire score) in BUD/FM- and FM-treated patients were generally worse with increasing COPD severity based on GOLD grade alone or combined GOLD classification. Outcomes were variable in patients receiving placebo. Regardless of COPD severity category or classification approach, treatment outcomes were better with BUD/FM versus FM and placebo for morning/evening PEF, rescue medication use, and St George’s Respiratory Questionnaire score.

CONCLUSIONS: In patients with moderate-very severe COPD, a robust BUD/FM response was observed across outcomes, regardless of COPD severity classified by GOLD grade or combined GOLD category.

CLINICAL IMPLICATIONS: Results suggest that COPD severity based on the combined GOLD assessment approach may not predict treatment response better than GOLD grade alone.

DISCLOSURE: Donald Tashkin: Consultant fee, speaker bureau, advisory committee, etc.: Boehringer-Ingelheim, Pfizer, Forest, AstraZeneca, Pearl Therapeutics, Sunovion, Mylan, Novartis, Theravance, University grant monies: no personal financial compensation: Boehringer-Ingelheim, Pearl Therapeutics, Sunovion, Novartis, GlaxoSmithKline Stephen Rennard: Consultant fee, speaker bureau, advisory committee, etc.: ABIM, Able Assoc, Align2 Action, Almirall, APT, AstraZeneca, Beilenson, BI, Chiesi, Clarus Acuity, COPD Foundation, DaiIchi Sankyo, Consultant fee, speaker bureau, advisory committee, etc.: Dunn Group, Easton Assoc, Elevation Pharma, Forest, Frankel Group, GersonLehman, Gilead, Globe Life Sciences, GSK Eclipse, Guidepoint Global, Health Advanced, J&J , Consultant fee, speaker bureau, advisory committee, etc.: Leerink Swan, McKinsey, Merck, Novartis, Nyco, Nycomed, Osterman, Pearl, Penn Technology, Pennside, Pfizer, Pro Ed Comm, Consultant fee, speaker bureau, advisory committee, etc.: Pulm Reviews, Pulmatrix, Saatchi and Saatchi, Sankyo, Schering, Shaw Science, Strategic North, Summer Street Research, Synapse, ThinkEquity, Consultant fee, speaker bureau, advisory committee, etc.: AARC, CME Incite, CTS Carmel, Fprest, HSC Medical Education, Lung Association, Nuvis, PeerVoice Tom Uryniak: Shareholder: AstraZeneca LP, Employee: AstraZeneca LP Ubaldo Martin: Shareholder: AstraZeneca LP, Employee: AstraZeneca LP Frank Trudo: Shareholder: AstraZeneca LP, Employee: AstraZeneca LP

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