1-year Study to Assess the Efficacy, Safety, and Tolerability of Glycopyrronium Bromide (NVA237) in Chronic Obstructive Pulmonary Disease (COPD)
NCT ID: NCT00929110
Last Updated: 2012-08-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1066 participants
INTERVENTIONAL
2009-06-30
2011-04-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Glycopyrronium bromide 50 μg
Patients inhaled glycopyrronium bromide 50 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Glycopyrronium bromide
Glycopyrronium bromide was supplied in powder-filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Placebo to glycopyrronium bromide
Patients inhaled placebo to glycopyrronium bromide once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Placebo to glycopyrronium bromide
Placebo to glycopyrronium bromide was supplied in powder-filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Tiotropium 18 μg
Patients inhaled tiotropium 18 μg once daily in the morning between 8:00 AM and 10:00 AM via a single-dose dry-powder inhaler (SDDPI) for 52 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Tiotropium
Tiotropium was supplied in powder-filled capsules together with the Handihaler® device.
Interventions
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Glycopyrronium bromide
Glycopyrronium bromide was supplied in powder-filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Placebo to glycopyrronium bromide
Placebo to glycopyrronium bromide was supplied in powder-filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.
Tiotropium
Tiotropium was supplied in powder-filled capsules together with the Handihaler® device.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patients with moderate to severe stable chronic obstructive pulmonary disease (COPD, Stage II or Stage III) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines 2008.
3. Current or ex-smokers who have a smoking history of at least 10 pack years.
4. Patients with a post-bronchodilator forced expiratory volume in 1 second (FEV1) ≥ 30% and \< 80% of the predicted normal, and post-bronchodilator FEV1/forced vital capacity (FVC) \< 0.7 at Visit 2 (Day -14).
5. Patients, according to daily electronic diary data between Visit 2 (Day -14) and Visit 3 (Day 1), with a total score of 1 or more on at least 4 of the last 7 days prior to Visit 3 (Day 1).
Exclusion Criteria
2. Women of child-bearing potential, unless using an approved method of medical or surgical contraception.
3. Patients requiring long term oxygen therapy (\> 15 h a day) on a daily basis for chronic hypoxemia, or who have been hospitalized for an exacerbation of their airways disease in the 6 weeks prior to Visit 1 (Day -21) or between Visit 1 (Day -21) and Visit 3 (Day 1).
4. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1 (Day -21).
5. Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition.
6. Patients with any history of asthma indicated by (but not limited to) a blood eosinophil count \> 600/mm\^3 (at Visit 1, Day -21) and onset of symptoms prior to age 40 years.
7. Patients with a history of long QT syndrome or whose QTc measured at Visit 1 (Day -21) (Fridericia method) is prolonged (\> 450 ms for males or \> 470 ms for females.
40 Years
ALL
No
Sponsors
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Novartis
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Montgomery, Alabama, United States
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Fort Smith, Arkansas, United States
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Anaheim, California, United States
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Fullerton, California, United States
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Lakewood, California, United States
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Los Angeles, California, United States
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Los Angeles, California, United States
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Mission Viejo, California, United States
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Paramount, California, United States
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Riverside, California, United States
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Rolling Hills Estates, California, United States
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San Diego, California, United States
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Colorado Springs, Colorado, United States
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DeLand, Florida, United States
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Fort Lauderdale, Florida, United States
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Miami, Florida, United States
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Miami Beach, Florida, United States
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Ocala, Florida, United States
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Panama City, Florida, United States
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Tampa, Florida, United States
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Winter Park, Florida, United States
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Atlanta, Georgia, United States
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Blue Ridge, Georgia, United States
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Duluth, Georgia, United States
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Coeur d'Alene, Idaho, United States
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Skokie, Illinois, United States
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New Albany, Indiana, United States
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Valparaiso, Indiana, United States
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Council Bluffs, Iowa, United States
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Iowa City, Iowa, United States
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Shawnee, Kansas, United States
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Crescent Springs, Kentucky, United States
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Crestview Hills, Kentucky, United States
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Hazard, Kentucky, United States
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Louisville, Kentucky, United States
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Lafayette, Louisiana, United States
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Sunset, Louisiana, United States
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Boys Town, Maine, United States
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Columbia, Maryland, United States
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Wheaton, Maryland, United States
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North Dartmouth, Massachusetts, United States
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Taunton, Massachusetts, United States
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Minneapolis, Minnesota, United States
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St Louis, Missouri, United States
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Bozeman, Montana, United States
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Lincoln, Nebraska, United States
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Omaha, Nebraska, United States
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Papillion, Nebraska, United States
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Skillman, New Jersey, United States
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Endwell, New York, United States
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Charlotte, North Carolina, United States
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Cincinnati, Ohio, United States
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Sylvania, Ohio, United States
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Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Oklahoma City, Oklahoma, United States
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Medford, Oregon, United States
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Medford, Oregon, United States
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Portland, Oregon, United States
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Portland, Oregon, United States
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Downingtown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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East Providence, Rhode Island, United States
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Providence, Rhode Island, United States
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North Charleston, South Carolina, United States
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Austin, Texas, United States
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El Paso, Texas, United States
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New Braunfels, Texas, United States
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San Antonio, Texas, United States
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Provo, Utah, United States
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Charlottesville, Virginia, United States
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Tacoma, Washington, United States
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Milwaukee, Wisconsin, United States
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Buenos Aires, , Argentina
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Capital Federal, , Argentina
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La Plata - Bueno Aire, , Argentina
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Parana Entre Rios, , Argentina
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Rosario, , Argentina
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San Miguel de Tucumán, , Argentina
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Brampton, , Canada
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Calgary, , Canada
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Edmonton, , Canada
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Kelowna, , Canada
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Langley, , Canada
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Niagara Falls, , Canada
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Québec, , Canada
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Ste-Foy, , Canada
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Santiago, , Chile
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Talcahuano, , Chile
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Viña del Mar, , Chile
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Dijon, , France
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Paris, , France
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Rennes, , France
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Berlin, , Germany
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Landsberg, , Germany
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Munich, , Germany
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München, , Germany
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Gyonsyos, , Hungary
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Siokok, , Hungary
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Beersheba, , Israel
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Haifa, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
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Rehovot, , Israel
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Florence, , Italy
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Monza, , Italy
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Parma, , Italy
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Guadalajara, , Mexico
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Monterrey, , Mexico
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San Luis Potosí City, , Mexico
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Sneek, , Netherlands
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Auckland, , New Zealand
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Christchurch, , New Zealand
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Hamilton, , New Zealand
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Tauranga, , New Zealand
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Wellington, , New Zealand
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Lima, , Peru
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Santiago de Surco, , Peru
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Bialystok, , Poland
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Bydgoszcz, , Poland
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Bystra, , Poland
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Gdansk, , Poland
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Krakow, , Poland
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Ostrów Wielkopolski, , Poland
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Piekary Slaskic, , Poland
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Tarnów, , Poland
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Warsaw, , Poland
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Barnaul, , Russia
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Irkutsk, , Russia
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Moscow, , Russia
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Smolensk, , Russia
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Volgograd, , Russia
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Yaroslavl, , Russia
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Busan, , South Korea
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Gyeonggi-go, , South Korea
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Incheon, , South Korea
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Seoul, , South Korea
Countries
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References
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D'Urzo A, Kerwin E, Overend T, D'Andrea P, Chen H, Goyal P. Once daily glycopyrronium for the treatment of COPD: pooled analysis of the GLOW1 and GLOW2 studies. Curr Med Res Opin. 2014 Mar;30(3):493-508. doi: 10.1185/03007995.2013.858618. Epub 2013 Nov 19.
Kerwin E, Hebert J, Gallagher N, Martin C, Overend T, Alagappan VK, Lu Y, Banerji D. Efficacy and safety of NVA237 versus placebo and tiotropium in patients with COPD: the GLOW2 study. Eur Respir J. 2012 Nov;40(5):1106-14. doi: 10.1183/09031936.00040712. Epub 2012 Jul 26.
Other Identifiers
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2008-008394-63
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CNVA237A2303
Identifier Type: -
Identifier Source: org_study_id