Clinical trial NCT01443845: Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)
Official title: Study to Evaluate the Effect of Roflumilast 500 μg on Exacerbation Rate in Subjects With Chronic Obstructive Pulmonary Disease (COPD) Treated With a Fixed-Dose Combination of Long-Acting Beta Agonist and Inhaled Corticosteroid (LABA/ICS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COPD
COPD Exacerbation
Lung Diseases
Respiratory Disorders
Pulmonary Disease
Chronic Obstructive Lung Diseases
Chronic Obstructive Airway Disease
Keywords: COPD
Exacerbations
Roflumilast
Daliresp
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2011-09-30
Enrollment: 2354
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.


Eligibility criteria: Inclusion Criteria:

* 1. Male or female patients at least 40 years of age
* 2. History of COPD (according to Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] 2010) for at least 12 months prior to Screening (Visit 1) associated with chronic productive cough for 3 months in each of 2 consecutive years (with other causes of productive cough excluded). Only patients with chronic bronchitis will be included (concomitant emphysema is permitted)
* 3. Forced expiratory volume after 1 second (FEV1)/forced vital capacity (FVC) ratio (postbronchodilator) \< 70% at Screening (Visit 1)
* 4. FEV1 (postbronchodilator) ≤ 50% of predicted at Screening (Visit 1)
* 5. At least two documented moderate or severe COPD exacerbations within 12 months prior to Screening (Visit 1)
* 6. Patients must be on FDC LABA/ICS treatment ≥ 3 months prior to Screening (Visit 1)
* 7. Former smokers (defined as smoking cessation at least 1 year ago) or current smokers (including patients who ceased smoking within the past year) both with a smoking history of at least 20 pack-years

Exclusion Criteria:

* 1. Moderate or severe COPD exacerbation and/or COPD exacerbations treated with antibiotics or systemic glucocorticosteroids within 4 weeks of Screening (Visit 1) (ie, patients must be clinically stable)
* 2. Known alpha-1-antitrypsin deficiency
* 3. Current diagnosis of asthma (either controlled or uncontrolled) (Note: History of childhood asthma is not exclusionary.)
* 4. Body mass index (BMI) ≥ 45 kg/m2
* 5. Patients with a history (within 5 years) or current diagnosis of cancer other than basal or squamous cell skin cancer

Primary outcomes:
measure: Rate of Moderate or Severe COPD Exacerbations Per Patient Per Year.
timeFrame: Baseline to Week 52
Secondary outcomes:
measure: Rate of COPD Exacerbations That Led to Hospitalization or Death (ie, Severe COPD Exacerbations)
timeFrame: Week 0 (Visit 2) to Week 52
measure: Rate of Moderate or Severe COPD Exacerbations or COPD Exacerbations Treated With Antibiotics
timeFrame: Week 0 (Visit 2) to Week 52
measure: Mean Change in Predose Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Week 0 (Visit 2) to Week 52
Other outcomes:
Locations:
city: Anniston
country: United States
facility: Forest Investigative Site 081
state: Alabama
city: Athens
country: United States
facility: Forest Investigative Site 065
state: Alabama
city: Florence
country: United States
facility: Forest Investigative Site 131
state: Alabama
city: Mobile
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facility: Forest Investigative Site 073
state: Alabama
city: Mesa
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facility: Forest Investigative Site 272
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facility: Forest Investigative Site 091
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city: Phoenix
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facility: Forest Investigative Site 034
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facility: Forest Investigative Site 188
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city: Phoenix
country: United States
facility: Forest Investigative Site 211
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city: Little Rock
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facility: Forest Investigative Site 101
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city: Fresno
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facility: Forest Investigative Site 060
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facility: Forest Investigative Site 329
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facility: Forest Investigative Site 297
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facility: Forest Investigative Site 116
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city: Los Angeles
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facility: Forest Investigative Site 085
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facility: Forest Investigative Site 268
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facility: Forest Investigative Site 025
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city: Torrance
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city: Brandon
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city: Brandon
country: United States
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city: Brandon
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facility: Forest Investigative Site 358
state: Florida
city: Chiefland
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state: Florida
city: Clearwater
country: United States
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city: Clearwater
country: United States
facility: Forest Investigative Site 123
state: Florida
city: Coral Gables
country: United States
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city: DeFuniak Springs
country: United States
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state: Florida
city: Fort Lauderdale
country: United States
facility: Forest Investigative Site 001
state: Florida
city: Fort Walton Beach
country: United States
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city: Gainesville
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city: Hollywood
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city: Jacksonville
country: United States
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state: Florida
city: Kissimmee
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city: Kissimmee
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state: Florida
city: Miami
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state: Florida
city: Miami
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state: Florida
city: Miami
country: United States
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state: Florida
city: Miami
country: United States
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state: Florida
city: Naples
country: United States
facility: Forest Investigative Site 092
state: Florida
city: Orlando
country: United States
facility: Forest Investigative Site 004
state: Florida
city: Ormond Beach
country: United States
facility: Forest Investigative Site 187
state: Florida
city: Pensacola
country: United States
facility: Forest Investigative Site 069
state: Florida
city: Ponte Vedra
country: United States
facility: Forest Investigative Site 161
state: Florida
city: Port Orange
country: United States
facility: Forest Investigative Site 087
state: Florida
city: Saint Petersburg
country: United States
facility: Forest Investigative Site 357
state: Florida
city: St. Cloud
country: United States
facility: Forest Investigative Site 109
state: Florida
city: St. Petersburg
country: United States
facility: Forest Investigative Site 121
state: Florida
city: Tamarac
country: United States
facility: Forest Investigative Site 002
state: Florida
city: Tampa
country: United States
facility: Forest Investigative Site 287
state: Florida
city: Tampa
country: United States
facility: Forest Investigative Site 052
state: Florida
city: Winter Park
country: United States
facility: Forest Investigative Site 011
state: Florida
city: Winter Park
country: United States
facility: Forest Investigative Site 348
state: Florida
city: Canton
country: United States
facility: Forest Investigative Site 103
state: Georgia
city: Dawsonville
country: United States
facility: Forest Investigative Site 292
state: Georgia
city: Duluth
country: United States
facility: Forest Investigative Site 042
state: Georgia
city: Gainesville
country: United States
facility: Forest Investigative Site 140
state: Georgia
city: Lawrenceville
country: United States
facility: Forest Investigative Site 030
state: Georgia
city: Woodstock
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facility: Forest Investigative Site 321
state: Georgia
city: Coeur d' Alene
country: United States
facility: Forest Investigative Site 008
state: Idaho
city: Eagle
country: United States
facility: Forest Investigative Site 119
state: Idaho
city: Bolingbrook
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facility: Forest Investigative Site 201
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city: Downers Grove
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facility: Forest Investigative Site 206
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city: Elk Grove Village
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facility: Forest Investigative Site 136
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city: Oak Lawn
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city: Peoria
country: United States
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city: Springfield
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city: Elwood
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city: Lafayette
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city: Michigan City
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city: Muncie
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city: Council Bluffs
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facility: Forest Investigative Site 135
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city: Iowa City
country: United States
facility: Forest Investigative Site 256
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city: Olathe
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city: Topeka
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city: Wichita
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facility: Forest Investigative Site 301
state: Kansas
city: Bowling Green
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facility: Forest Investigative Site 051
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city: Crescent Springs
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facility: Forest Investigative Site 075
state: Kentucky
city: Hazard
country: United States
facility: Forest Investigative Site 351
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city: Lexington
country: United States
facility: Forest Investigative Site 068
state: Kentucky
city: Louisville
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facility: Forest Investigative Site 088
state: Kentucky
city: Owensboro
country: United States
facility: Forest Investigative Site 053
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city: Lafayette
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facility: Forest Investigative Site 273
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city: Opelousas
country: United States
facility: Forest Investigative Site 070
state: Louisiana
city: Sunset
country: United States
facility: Forest Investigative Site 097
state: Louisiana
city: Lewiston
country: United States
facility: Forest Investigative Site 128
state: Maine
city: Baltimore
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city: Columbia
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facility: Forest Investigative Site 020
state: Maryland
city: Towson
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facility: Forest Investigative Site 072
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city: Fall River
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state: Massachusetts
city: North Dartmouth
country: United States
facility: Forest Investigative Site 044
state: Massachusetts
city: Pittsfield
country: United States
facility: Forest Investigative Site 350
state: Massachusetts
city: Ann Arbor
country: United States
facility: Forest Investigative Site 157
state: Michigan
city: Detroit
country: United States
facility: Forest Investigative Site 341
state: Michigan
city: Kalamazoo
country: United States
facility: Forest Investigative Site 328
state: Michigan
city: Livonia
country: United States
facility: Forest Investigative Site 063
state: Michigan
city: Saint Joseph
country: United States
facility: Forest Investigative Site 322
state: Michigan
city: Edina
country: United States
facility: Forest Investigative Site 303
state: Minnesota
city: Fridley
country: United States
facility: Forest Investigative Site 056
state: Minnesota
city: Rochester
country: United States
facility: Forest Investigative Site 082
state: Minnesota
city: Chesterfield
country: United States
facility: Forest Investigative Site 033
state: Missouri
city: Springfield
country: United States
facility: Forest Investigative Site 117
state: Missouri
city: St. Charles
country: United States
facility: Forest Investigative Site 098
state: Missouri
city: St. Louis
country: United States
facility: Forest Investigative Site 186
state: Missouri
city: St. Louis
country: United States
facility: Forest Investigative Site 288
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city: Butte
country: United States
facility: Forest Investigative Site 333
state: Montana
city: Missoula
country: United States
facility: Forest Investigative Site 029
state: Montana
city: Bellevue
country: United States
facility: Forest Investigative Site 197
state: Nebraska
city: Fremont
country: United States
facility: Forest Investigative Site 267
state: Nebraska
city: Fremont
country: United States
facility: Forest Investigative Site 337
state: Nebraska
city: Lincoln
country: United States
facility: Forest Investigative Site 315
state: Nebraska
city: Lincoln
country: United States
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state: Nebraska
city: Omaha
country: United States
facility: Forest Investigative Site 345
state: Nebraska
city: Henderson
country: United States
facility: Forest Investigative Site 079
state: Nevada
city: Henderson
country: United States
facility: Forest Investigative Site 270
state: Nevada
city: Cherry Hill
country: United States
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state: New Jersey
city: Clifton
country: United States
facility: Forest Investigative Site 327
state: New Jersey
city: Hackensack
country: United States
facility: Forest Investigative Site 144
state: New Jersey
city: Summit
country: United States
facility: Forest Investigative Site 317
state: New Jersey
city: Brooklyn
country: United States
facility: Forest Investigative Site 226
state: New York
city: Great Neck
country: United States
facility: Forest Investigative Site 199
state: New York
city: New York
country: United States
facility: Forest Investigative Site 071
state: New York
city: Rochester
country: United States
facility: Forest Investigative Site 013
state: New York
city: Syracuse
country: United States
facility: Forest Investigative Site 066
state: New York
city: West Seneca
country: United States
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state: New York
city: Asheville
country: United States
facility: Forest Investigative Site 313
state: North Carolina
city: Burlington
country: United States
facility: Forest Investigative Site 193
state: North Carolina
city: Charlotte
country: United States
facility: Forest Investigative Site 142
state: North Carolina
city: Charlotte
country: United States
facility: Forest Investigative Site 259
state: North Carolina
city: Elizabeth City
country: United States
facility: Forest Investigative Site 019
state: North Carolina
city: Shelby
country: United States
facility: Forest Investigative Site 318
state: North Carolina
city: Shelby
country: United States
facility: Forest Investigative Site 078
state: North Carolina
city: Wilmington
country: United States
facility: Forest Investigative Site 176
state: North Carolina
city: Winston Salem
country: United States
facility: Forest Investigative Site 314
state: North Carolina
city: Winston-Salem
country: United States
facility: Forest Investigative Site 282
state: North Carolina
city: Canton
country: United States
facility: Forest Investigative Site 164
state: Ohio
city: Cincinatti
country: United States
facility: Forest Investigative Site 061
state: Ohio
city: Cincinnati
country: United States
facility: Forest Investigative Site 149
state: Ohio
city: Cincinnati
country: United States
facility: Forest Investigative Site 040
state: Ohio
city: Cincinnati
country: United States
facility: Forest Investigative Site 280
state: Ohio
city: Columbus
country: United States
facility: Forest Investigative Site 009
state: Ohio
city: Dayton
country: United States
facility: Forest Investigative Site 353
state: Ohio
city: Marion
country: United States
facility: Forest Investigative Site 059
state: Ohio
city: Marion
country: United States
facility: Forest Investigative Site 154
state: Ohio
city: Toledo
country: United States
facility: Forest Investigative Site 346
state: Ohio
city: Zanesville
country: United States
facility: Forest Investigative Site 105
state: Ohio
city: Oklahoma City
country: United States
facility: Forest Investigative Site 167
state: Oklahoma
city: Oklahoma City
country: United States
facility: Forest Investigative Site 281
state: Oklahoma
city: Tulsa
country: United States
facility: Forest Investigative Site 236
state: Oklahoma
city: Medford
country: United States
facility: Forest Investigative Site 285
state: Oregon
city: Portland
country: United States
facility: Forest Investigative Site 289
state: Oregon
city: Portland
country: United States
facility: Forest Investigative Site 218
state: Oregon
city: Altoona
country: United States
facility: Forest Investigative Site 086
state: Pennsylvania
city: Beaver
country: United States
facility: Forest Investigative Site 340
state: Pennsylvania
city: Downingtown
country: United States
facility: Forest Investigative Site 120
state: Pennsylvania
city: Erie
country: United States
facility: Forest Investigative Site 062
state: Pennsylvania
city: Norristown
country: United States
facility: Forest Investigative Site 277
state: Pennsylvania
city: Philadelphia
country: United States
facility: Forest Investigative Site 230
state: Pennsylvania
city: Philadelphia
country: United States
facility: Forest Investigative Site 205
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Forest Investigative Site 336
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Forest Investigative Site 364
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Forest Investigative Site 344
state: Pennsylvania
city: Tipton
country: United States
facility: Forest Investigative Site 010
state: Pennsylvania
city: Uniontown
country: United States
facility: Forest Investigative Site 064
state: Pennsylvania
city: Johnston
country: United States
facility: Forest Investigative Site 228
state: Rhode Island
city: Lincoln
country: United States
facility: Forest Investigative Site 283
state: Rhode Island
city: Providence
country: United States
facility: Forest Investigative Site 365
state: Rhode Island
city: Charleston
country: United States
facility: Forest Investigative Site 305
state: South Carolina
city: Easley
country: United States
facility: Forest Investigative Site 093
state: South Carolina
city: Fort Mill
country: United States
facility: Forest Investigative Site 257
state: South Carolina
city: Gaffney
country: United States
facility: Forest Investigative Site 233
state: South Carolina
city: Greenville
country: United States
facility: Forest Investigative Site 110
state: South Carolina
city: Pelzer
country: United States
facility: Forest Investigative Site 300
state: South Carolina
city: Rock Hill
country: United States
facility: Forest Investigative Site 204
state: South Carolina
city: Spartanburg
country: United States
facility: Forest Investigative Site 021
state: South Carolina
city: Union
country: United States
facility: Forest Investigative Site 012
state: South Carolina
city: Rapid City
country: United States
facility: Forest Investigative Site 058
state: South Dakota
city: Bristol
country: United States
facility: Forest Investigative Site 223
state: Tennessee
city: Fayetteville
country: United States
facility: Forest Investigative Site 050
state: Tennessee
city: Shelbyville
country: United States
facility: Forest Investigative Site 253
state: Tennessee
city: Arlington
country: United States
facility: Forest Investigative Site 024
state: Texas
city: Boerne
country: United States
facility: Forest Investigative Site 177
state: Texas
city: Corsicana
country: United States
facility: Forest Investigative Site 090
state: Texas
city: Dallas
country: United States
facility: Forest Investigative Site 172
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 237
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 271
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 370
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 195
state: Texas
city: Houston
country: United States
facility: Forest Investigative Site 312
state: Texas
city: Huntsville
country: United States
facility: Forest Investigative Site 332
state: Texas
city: Longview
country: United States
facility: Forest Investigative Site 232
state: Texas
city: Tyler
country: United States
facility: Forest Investigative Site 049
state: Texas
city: Colchester
country: United States
facility: Forest Investigative Site 181
state: Vermont
city: Abingdon
country: United States
facility: Forest Investigative Site 125
state: Virginia
city: Richmond
country: United States
facility: Forest Investigative Site 202
state: Virginia
city: Richmond
country: United States
facility: Forest Investigative Site 231
state: Virginia
city: Richmond
country: United States
facility: Forest Investigative Site 045
state: Virginia
city: Spokane
country: United States
facility: Forest Investigative Site 184
state: Washington
city: Spokane
country: United States
facility: Forest Investigative Site 174
state: Washington
city: Tacoma
country: United States
facility: Forest Investigative Site 217
state: Washington
city: Charleston
country: United States
facility: Forest Investigative Site 335
state: West Virginia
city: Morgantown
country: United States
facility: Forest Investigative Site 319
state: West Virginia
city: West Allis
country: United States
facility: Forest Investigative Site 146
state: Wisconsin
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Forest Investigative Site 418
state: Buenos Aires
city: Florida
country: Argentina
facility: Forest Investigative Site 402
state: Buenos Aires
city: La Plata
country: Argentina
facility: Forest Investigative Site 405
state: Buenos Aires
city: Mar del Plata
country: Argentina
facility: Forest Investigative Site 413
state: Buenos Aires
city: Parana
country: Argentina
facility: Forest Investigative Site 407
state: Entre Rios
city: Lanús Este
country: Argentina
facility: Forest Investigative Site 406
state: Provincia de Buenos Aires
city: Rosario
country: Argentina
facility: Forest Investigative Site 412
state: Santa Fe
city: Rosario
country: Argentina
facility: Forest Investigative Site 409
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Forest Investigative Site 403
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Forest Investigative Site 411
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Forest Investigative Site 414
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Forest Investigative Site 419
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Forest Investigative Site 416
city: Derqui Pilar - Buenos Aires
country: Argentina
facility: Forest Investigative Site 415
city: Florencio Varela
country: Argentina
facility: Forest Investigative Site 410
city: La Plata
country: Argentina
facility: Forest Investigative Site 417
city: Mendoza
country: Argentina
facility: Forest Investigative Site 420
city: Mendoza
country: Argentina
facility: Forest Investigative Site 404
city: San Miguel de Tucuman
country: Argentina
facility: Forest Investigative Site 401
city: Santa Fe
country: Argentina
facility: Forest Investigative Site 408
city: Calgary
country: Canada
facility: Forest Investigative Site 235
state: Alberta
city: North Vancouver
country: Canada
facility: Forest Investigative Site 162
state: British Columbia
city: Burlington
country: Canada
facility: Forest Investigative Site 302
state: Ontario
city: Montreal
country: Canada
facility: Forest Investigative Site 185
state: Quebec
city: Saskatoon
country: Canada
facility: Forest Investigative Site 127
state: Saskatchewan
city: Talcahuano
country: Chile
facility: Forest Investigative Site 421
city: Bogota
country: Colombia
facility: Forest Investigative Site 442
city: Bogota
country: Colombia
facility: Forest Investigative Site 443
city: Chieti
country: Italy
facility: Forest Investigative Site 461
city: Roma
country: Italy
facility: Forest Investigative Site 464
city: Batu Caves
country: Malaysia
facility: Forest Investigative Site 505
city: Kuala Lumpur
country: Malaysia
facility: Forest Investigative Site 501
city: Kuala Lumpur
country: Malaysia
facility: Forest Investigative Site 504
city: Kuantan
country: Malaysia
facility: Forest Investigative Site 502
city: Monterrey
country: Mexico
facility: Forest Investigative Site 522
state: Nuevo León
city: Merida
country: Mexico
facility: Forest Investigative Site 526
state: Yucatan
city: Guadalajara
country: Mexico
facility: Forest Investigative Site 524
city: Monterrey
country: Mexico
facility: Forest Investigative Site 521
city: Bellavista
country: Peru
facility: Forest Investigative Site 543
city: Lima
country: Peru
facility: Forest Investigative Site 550
city: Lima
country: Peru
facility: Forest Investigative Site 551
city: Lima
country: Peru
facility: Forest Investigative Site 545
city: Lima
country: Peru
facility: Forest Investigative Site 546
city: Lima
country: Peru
facility: Forest Investigative Site 549
city: Lima
country: Peru
facility: Forest Investigative Site 544
city: Pueblo Libre
country: Peru
facility: Forest Investigative Site 541
city: Cavite
country: Philippines
facility: Forest Investigative Site 569
city: Iloilo City
country: Philippines
facility: Forest Investigative Site 567
city: Iloilo City
country: Philippines
facility: Forest Investigative Site 568
city: Manila
country: Philippines
facility: Forest Investigative Site 565
city: Pasig City
country: Philippines
facility: Forest Investigative Site 563
city: Quezon City
country: Philippines
facility: Forest Investigative Site 562
city: Quezon City
country: Philippines
facility: Forest Investigative Site 564
city: Quezon City
country: Philippines
facility: Forest Investigative Site 566
city: Quezon City
country: Philippines
facility: Forest Investigative Site 561
city: Brasov
country: Romania
facility: Forest Investigative Site 585
city: Bucharest
country: Romania
facility: Forest Investigative Site 586
city: Bucharest
country: Romania
facility: Forest Investigative Site 587
city: Bucharest
country: Romania
facility: Forest Investigative Site 588
city: Bucharest
country: Romania
facility: Forest Investigative Site 584
city: Bucharest
country: Romania
facility: Forest Investigative Site 582
city: Iasi
country: Romania
facility: Forest Investigative Site 581
city: Iasi
country: Romania
facility: Forest Investigative Site 583
city: Barnaul
country: Russian Federation
facility: Forest Investigative Site 608
city: Kazan
country: Russian Federation
facility: Forest Investigative Site 602
city: Kemerovo
country: Russian Federation
facility: Forest Investigative Site 618
city: Krasnodar
country: Russian Federation
facility: Forest Investigative Site 609
city: Krasnoyarsk
country: Russian Federation
facility: Forest Investigative Site 614
city: Moscow
country: Russian Federation
facility: Forest Investigative Site 617
city: Novosibirsk
country: Russian Federation
facility: Forest Investigative Site 605
city: St Petersburg
country: Russian Federation
facility: Forest Investigative Site 600
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site 612
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site 619
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site 604
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site 611
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site 610
city: St. Petersburg
country: Russian Federation
facility: Forest Investigative Site 601
city: St.Petersburg
country: Russian Federation
facility: Forest Investigative Site 606
city: Tomsk
country: Russian Federation
facility: Forest Investigative Site 607
city: Yaroslavl
country: Russian Federation
facility: Forest Investigative Site 620
city: Knez Selo
country: Serbia
facility: Forest Investigative Site 629
state: Nišava District
city: Belgrade
country: Serbia
facility: Forest Investigative Site 622
city: Belgrade
country: Serbia
facility: Forest Investigative Site 623
city: Belgrade
country: Serbia
facility: Forest Investigative Site 624
city: Beograd
country: Serbia
facility: Forest Investigative Site 625
city: Kragujevac
country: Serbia
facility: Forest Investigative Site 628
city: Sremska Kamenica
country: Serbia
facility: Forest Investigative Site 627
city: Cadiz
country: Spain
facility: Forest Investigative Site 641
city: Loja
country: Spain
facility: Forest Investigative Site 647
city: Salt
country: Spain
facility: Forest Investigative Site 644
city: Kaohsiung Hsien
country: Taiwan
facility: Forest Investigative Site 723
city: Puzih City
country: Taiwan
facility: Forest Investigative Site 724
city: Taipei
country: Taiwan
facility: Forest Investigative Site 725
city: Taipei
country: Taiwan
facility: Forest Investigative Site 722
city: Hat Yai
country: Thailand
facility: Forest Investigative Site 662
state: Songkhla
city: Bangkok
country: Thailand
facility: Forest Investigative Site 664
city: Bangkok
country: Thailand
facility: Forest Investigative Site 663
city: Muang
country: Thailand
facility: Forest Investigative Site 661
city: Cherkasy
country: Ukraine
facility: Forest Investigative Site 699
city: Dnipropetrovsk
country: Ukraine
facility: Forest Investigative Site 691
city: Donetsk
country: Ukraine
facility: Forest Investigative Site 692
city: Donetsk
country: Ukraine
facility: Forest Investigative Site 689
city: Ivano-Frankivsk
country: Ukraine
facility: Forest Investigative Site 690
city: Kharkiv
country: Ukraine
facility: Forest Investigative Site 697
city: Kharkiv
country: Ukraine
facility: Forest Investigative Site 693
city: Kharkiv
country: Ukraine
facility: Forest Investigative Site 682
city: Kremenchuk
country: Ukraine
facility: Forest Investigative Site 709
city: Kyiv
country: Ukraine
facility: Forest Investigative Site 698
city: Kyiv
country: Ukraine
facility: Forest Investigative Site 683
city: Kyiv
country: Ukraine
facility: Forest Investigative Site 684
city: Kyiv
country: Ukraine
facility: Forest Investigative Site 687
city: Kyiv
country: Ukraine
facility: Forest Investigative Site 685
city: Lviv
country: Ukraine
facility: Forest Investigative Site 681
city: Mykolayiv
country: Ukraine
facility: Forest Investigative Site 708
city: Poltava
country: Ukraine
facility: Forest Investigative Site 706
city: Sumy
country: Ukraine
facility: Forest Investigative Site 695
city: Vinnitsa
country: Ukraine
facility: Forest Investigative Site 707
city: Zaporizhzhia
country: Ukraine
facility: Forest Investigative Site 688
city: Zaporizhzhya
country: Ukraine
facility: Forest Investigative Site 696
city: Zaporizhzhya
country: Ukraine
facility: Forest Investigative Site 694
city: Zaporizhzhya
country: Ukraine
facility: Forest Investigative Site 705
Study officials:
References:
citation: Martinez FJ, Rabe KF, Calverley PMA, Fabbri LM, Sethi S, Pizzichini E, McIvor A, Anzueto A, Alagappan VKT, Siddiqui S, Reisner C, Zetterstrand S, Roman J, Purkayastha D, Bagul N, Rennard SI. Determinants of Response to Roflumilast in Severe Chronic Obstructive Pulmonary Disease. Pooled Analysis of Two Randomized Trials. Am J Respir Crit Care Med. 2018 Nov 15;198(10):1268-1278. doi: 10.1164/rccm.201712-2493OC.
citation: Karpefors M, Weatherall J. The Tendril Plot-a novel visual summary of the incidence, significance and temporal aspects of adverse events in clinical trials. J Am Med Inform Assoc. 2018 Aug 1;25(8):1069-1073. doi: 10.1093/jamia/ocy016.
citation: Martinez FJ, Rabe KF, Sethi S, Pizzichini E, McIvor A, Anzueto A, Alagappan VK, Siddiqui S, Rekeda L, Miller CJ, Zetterstrand S, Reisner C, Rennard SI. Effect of Roflumilast and Inhaled Corticosteroid/Long-Acting beta2-Agonist on Chronic Obstructive Pulmonary Disease Exacerbations (RE(2)SPOND). A Randomized Clinical Trial. Am J Respir Crit Care Med. 2016 Sep 1;194(5):559-67. doi: 10.1164/rccm.201607-1349OC.