O'Brien, Thomas; Orr, Robert; Palatnik, Mikhail; Palmer, April; Pearle, James; Pham, David; Philips, David; Pluto, Tiffany; Pudi, Krishna; Ricci, Donato; Robinson, Keith; Ryan, Stephen; Santiago, Jose; Shah, Amit; Shapero, Paul; Sibille, John; Siri, Dareen; Smyth, Denise; Southard, John; Spector, Sheldon; Sugimoto, Danny; Sussman, Robert; Tabbah, Isam; Tan, Ricardo; Tarshis, Gary; Taylor, Latimer; Thompson, Charles; Torres, Diego; Torres, Louis; Trapp, John; Trevino, Miguel; Villareal, Manuel; Weinberg, Paul; Westerman, Jan; White, Jeffrey; Windom, Hugh; Wolfe, Robert; Wyatt, David; Zhou, Joseph. Inclusion Criteria Signed informed consent at enrollment visit obtained before conducting any study-related procedure including withdrawal of medications Outpatients; men or women aged years ≥40 A current clinical diagnosis of COPD with COPD symptoms for more than 1 year, according to the Global Initiative for Chronic Obstructive Lung Disease guidelines Current or previous smoker with a smoking history equivalent to 10 or more pack-years year = 20 cigarettes smoked per day for 1 year) Postbronchodilator FEV1/FVC <0.7 (70%) and FEV1 of predicted normal value ≤70% Documented use of a short-acting inhaled bronchodilator (β2-agonists or anticholinergics) as rescue medication within 6 months before study start A score of on the Modified Medical Research Council dyspnea scale ≥2 Documented history of moderate or severe COPD exacerbation(s) that required treatment ≥1 with systemic (oral, intramuscular, intravenous) corticosteroids (a minimum of a 3-day course of an oral corticosteroid treatment or single depot corticosteroid injection), or hospitalization (defined as an inpatient stay or >24-hour stay in an observation area in the emergency department or other equivalent facility depending on the country and healthcare system) within 2 to 52 weeks before enrollment (ie, not within the 14 days before
O'Brien, Thomas; Orr, Robert; Palatnik, Mikhail; Palmer, April; Pearle, James; Pham, David; Philips, David; Pluto, Tiffany; Pudi, Krishna; Ricci, Donato; Robinson, Keith; Ryan, Stephen; Santiago, Jose; Shah, Amit; Shapero, Paul; Sibille, John; Siri, Dareen; Smyth, Denise; Southard, John; Spector, Sheldon; Sugimoto, Danny; Sussman, Robert; Tabbah, Isam; Tan, Ricardo; Tarshis, Gary; Taylor, Latimer; Thompson, Charles; Torres, Diego; Torres, Louis; Trapp, John; Trevino, Miguel; Villareal, Manuel; Weinberg, Paul; Westerman, Jan; White, Jeffrey; Windom, Hugh; Wolfe, Robert; Wyatt, David; Zhou, Joseph. Inclusion Criteria Signed informed consent at enrollment visit obtained before conducting any study-related procedure including withdrawal of medications Outpatients; men or women aged ≥40 years A current clinical diagnosis of COPD with COPD symptoms for more than 1 year, according to the Global Initiative for Chronic Obstructive Lung Disease guidelines Current or previous smoker with a smoking history equivalent to 10 or more pack-years year = 20 cigarettes smoked per day for 1 year) Postbronchodilator FEV1/FVC <0.7 (70%) and FEV1 ≤70% of predicted normal value Documented use of a short-acting inhaled bronchodilator (β2-agonists or anticholinergics) as rescue medication within 6 months before study start A score of ≥2 on the Modified Medical Research Council dyspnea scale Documented history of ≥1 moderate or severe COPD exacerbation(s) that required treatment with systemic (oral, intramuscular, intravenous) corticosteroids (a minimum of a 3-day course of an oral corticosteroid treatment or single depot corticosteroid injection), or hospitalization (defined as an inpatient stay or >24-hour stay in an observation area in the emergency department or other equivalent facility depending on the country and healthcare system) within 2 to 52 weeks before enrollment (ie, not within the 14 days before