Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)
NCT ID: NCT01443845
Last Updated: 2017-04-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
2354 participants
INTERVENTIONAL
2011-09-30
2016-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
Roflumilast
Roflumilast
Roflumilast 500 µg, oral administration, once per day
2
Placebo
Placebo
Dose-matched placebo, oral administration, once per day.
Interventions
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Roflumilast
Roflumilast 500 µg, oral administration, once per day
Placebo
Dose-matched placebo, oral administration, once per day.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
40 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Locations
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Anniston, Alabama, United States
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Long Beach, California, United States
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St. Petersburg, Florida, United States
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Canton, Georgia, United States
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Lexington, Kentucky, United States
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Owensboro, Kentucky, United States
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Lafayette, Louisiana, United States
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Ann Arbor, Michigan, United States
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Tacoma, Washington, United States
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Charleston, West Virginia, United States
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Morgantown, West Virginia, United States
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West Allis, Wisconsin, United States
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Buenos Aires, Buenos Aires, Argentina
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Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
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Florida, Buenos Aires, Argentina
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La Plata, Buenos Aires, Argentina
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Lanús Este, Buenos Aires, Argentina
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Mar del Plata, Buenos Aires, Argentina
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Paraná, Entre Ríos Province, Argentina
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Mendoza, Mendoza Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Rosario, Santa Fe Province, Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Buenos Aires, , Argentina
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Derqui Pilar - Buenos Aires, , Argentina
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La Plata, , Argentina
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Mendoza, , Argentina
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San Juan Bautista, , Argentina
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San Miguel de Tucumán, , Argentina
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Santa Fe, , Argentina
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Calgary, Alberta, Canada
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North Vancouver, British Columbia, Canada
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Burlington, Ontario, Canada
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Montreal, Quebec, Canada
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Saskatoon, Saskatchewan, Canada
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Talcahuano, , Chile
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Bogotá, , Colombia
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Bogotá, , Colombia
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Chieti, , Italy
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Roma, , Italy
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Batu Caves, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuala Lumpur, , Malaysia
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Kuantan, , Malaysia
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Monterrey, Nuevo León, Mexico
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Mérida, Yucatán, Mexico
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Guadalajara, , Mexico
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Monterrey, , Mexico
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Bellavista, , Peru
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Lima, , Peru
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Lima, , Peru
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Lima, , Peru
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Pueblo Libre, , Peru
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Cavite, , Philippines
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Iloilo City, , Philippines
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Manila, , Philippines
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Pasig, , Philippines
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Quezon City, , Philippines
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Quezon City, , Philippines
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Brasov, , Romania
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Iași, , Romania
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Iași, , Romania
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Barnaul, , Russia
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Kazan', , Russia
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Kemerovo, , Russia
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Krasnodar, , Russia
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Krasnoyarsk, , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Tomsk, , Russia
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Yaroslavl, , Russia
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Knez-Selo, Nišava District, Serbia
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Belgrade, , Serbia
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Belgrade, , Serbia
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Belgrade, , Serbia
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Belgrade, , Serbia
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Kamenitz, , Serbia
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Kragujevac, , Serbia
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Cadiz, , Spain
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Loja, , Spain
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Salt, , Spain
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Kaohsiung Hsien, , Taiwan
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Puzih City, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Hat Yai, Changwat Songkhla, Thailand
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Bangkok, , Thailand
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Bangkok, , Thailand
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Muang, , Thailand
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Cherkasy, , Ukraine
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Dnipropetrovsk, , Ukraine
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Donetsk, , Ukraine
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Donetsk, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kharkiv, , Ukraine
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Kremenchuk, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Lviv, , Ukraine
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Mykolayiv, , Ukraine
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Poltava, , Ukraine
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Sumy, , Ukraine
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Vinnitsa, , Ukraine
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Zaporizhzhia, , Ukraine
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Zaporizhzhya, , Ukraine
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Zaporizhzhya, , Ukraine
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Zaporizhzhya, , Ukraine
Countries
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References
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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.
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.
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.
Related Links
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Other Identifiers
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ROF-MD-07
Identifier Type: -
Identifier Source: org_study_id
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