1-year Study to Assess the Efficacy, Safety, and Tolerability of Glycopyrronium Bromide (NVA237) in Chronic Obstructive Pulmonary Disease (COPD)

NCT00929110 | Completed Phase 3 Results

• 2 other identifiers: CNVA237A23032008-008394-63
• Study Type: interventional
• Target: 1,066
• Locations: 16 countries
• Sites: 139

Brief Summary

This study was designed to investigate the 1 year efficacy and safety of the 50 µg once daily (od) dose of glycopyrronium bromide (NVA237) in patients with moderate to severe chronic obstructive pulmonary disease.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; NVA237; glycopyrronium bromide

Outcome Measures

Primary Outcomes (1)

• Trough Forced Expiratory Volume in 1 Second (FEV1) at Week 12

  FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 15 minutes and 23 hours 45 minutes post-dose. The analysis included baseline FEV1 measurement, baseline inhaled corticosteroid use (Yes/No), FEV1 prior to inhalation of short-acting β2 agonist (SABA), and FEV1 45 min post-inhalation of SABA as covariates.

  Week 12

Secondary Outcomes (19)

• Transition Dyspnea Index (TDI) at Week 26

  Week 26

• Health-related Quality of Life (QoL) Assessed With the St. George Respiratory Questionnaire (SGRQ) at Week 52

  Week 52

• Time to First Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation During the Study (Baseline to Week 52)

  Baseline to Week 52 (patients with no moderate or severe exacerbations who completed the study were censored at the final visit date, which may have exceeded 52 weeks)

• Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Taken During the Study (Baseline to Week 52)

  Baseline to Week 52

• Trough Forced Expiratory Volume in 1 Second (FEV1) at Day 1, Week 26, and Week 52

  Day 1, Week 26, and Week 52

Study Arms (3)

Glycopyrronium bromide 50 μg

EXPERIMENTAL

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.

Drug: Glycopyrronium bromide

Placebo to glycopyrronium bromide

PLACEBO COMPARATOR

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.

Drug: Placebo to glycopyrronium bromide

Tiotropium 18 μg

ACTIVE COMPARATOR

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.

Drug: Tiotropium

Interventions

Glycopyrronium bromide DRUG

Glycopyrronium bromide was supplied in powder-filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Also known as: NVA237

Glycopyrronium bromide 50 μg

Placebo to glycopyrronium bromide DRUG

Placebo to glycopyrronium bromide was supplied in powder-filled capsules together with a single-dose dry-powder inhaler (SDDPI) device.

Placebo to glycopyrronium bromide

Tiotropium DRUG

Tiotropium was supplied in powder-filled capsules together with the Handihaler® device.

Tiotropium 18 μg

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female adults aged ≥ 40 years, who have signed an Informed Consent Form prior to initiation of any study-related procedure.
• 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.
• Current or ex-smokers who have a smoking history of at least 10 pack years.
• 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).
• 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).

You may not qualify if:

• Pregnant women or nursing mothers (pregnancy confirmed by positive urine pregnancy test).
• Women of child-bearing potential, unless using an approved method of medical or surgical contraception.
• 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).
• Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1 (Day -21).
• Patients who, in the judgment of the investigator or the responsible Novartis personnel, have a clinically relevant laboratory abnormality or a clinically significant condition.
• 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.
• 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (139)

Novartis Investigative Site

Birmingham, Alabama, 35249, United States

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Mobile, Alabama, 36608, United States

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Montgomery, Alabama, 36117, United States

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Fort Smith, Arkansas, 72901, United States

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Anaheim, California, 92801, United States

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Fullerton, California, 92835, United States

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Lakewood, California, 90712-151, United States

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Los Angeles, California, 90025, United States

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Los Angeles, California, 90048, United States

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Mission Viejo, California, 92691, United States

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Paramount, California, 90723, United States

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Riverside, California, 92506, United States

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Rolling Hills Estates, California, 90274, United States

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San Diego, California, 92120, United States

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Colorado Springs, Colorado, 80907, United States

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DeLand, Florida, 32720, United States

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Fort Lauderdale, Florida, 33316-192, United States

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Miami, Florida, 33186, United States

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Miami Beach, Florida, 33140, United States

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Ocala, Florida, 34471, United States

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Panama City, Florida, 32405, United States

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Tampa, Florida, 33606, United States

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Winter Park, Florida, 32789, United States

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Atlanta, Georgia, 30322, United States

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Blue Ridge, Georgia, 30513, United States

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Duluth, Georgia, 30096, United States

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Coeur d'Alene, Idaho, 83814, United States

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Skokie, Illinois, 60076, United States

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New Albany, Indiana, 47150-3054, United States

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Valparaiso, Indiana, 46383, United States

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Council Bluffs, Iowa, 51503-4658, United States

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Iowa City, Iowa, 52240, United States

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Shawnee, Kansas, 66216-1800, United States

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Novartis Investigative Center

Crescent Springs, Kentucky, 41017, United States

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Crestview Hills, Kentucky, 41017-542, United States

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Hazard, Kentucky, 41701, United States

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Louisville, Kentucky, 40215, United States

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Lafayette, Louisiana, 70508, United States

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Sunset, Louisiana, 70584, United States

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Boys Town, Maine, 68010, United States

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Columbia, Maryland, 21044, United States

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Wheaton, Maryland, 20902, United States

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North Dartmouth, Massachusetts, 02747, United States

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Taunton, Massachusetts, 02780, United States

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Minneapolis, Minnesota, 55402, United States

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St Louis, Missouri, 63122, United States

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Bozeman, Montana, 59718, United States

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Lincoln, Nebraska, 68510, United States

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Omaha, Nebraska, 68131-2197, United States

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Papillion, Nebraska, 68046, United States

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Skillman, New Jersey, 08558, United States

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Endwell, New York, 13760, United States

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Charlotte, North Carolina, 28207, United States

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Cincinnati, Ohio, 45245, United States

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Sylvania, Ohio, 43560, United States

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Toledo, Ohio, 43614, United States

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Oklahoma City, Oklahoma, 73103, United States

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Oklahoma City, Oklahoma, 73112, United States

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Medford, Oregon, 97504-8741, United States

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Medford, Oregon, 97504, United States

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Portland, Oregon, 92713, United States

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Portland, Oregon, 97213, United States

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Downingtown, Pennsylvania, 19335-2620, United States

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Philadelphia, Pennsylvania, 19115, United States

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East Providence, Rhode Island, 02914, United States

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Providence, Rhode Island, 02906, United States

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North Charleston, South Carolina, 29406, United States

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Austin, Texas, 78750, United States

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El Paso, Texas, 79902, United States

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New Braunfels, Texas, 78130-6113, United States

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San Antonio, Texas, 78229, United States

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Provo, Utah, 84604-1584, United States

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Charlottesville, Virginia, 22908, United States

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Tacoma, Washington, 98405-4266, United States

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Milwaukee, Wisconsin, 53209, 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

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Related Publications (2)

• 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.

  PMID: 24156566 DERIVED

• 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.

  PMID: 23060624 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Glycopyrrolate; Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quaternary Ammonium Compounds; Amines; Organic Chemicals; Onium Compounds; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862 778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: June 26, 2009
• Study Start: June 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: August 17, 2012
• Results First Posted: July 27, 2012

Record last verified: 2012-08

Locations

US (75); HU (2); NZ (5); CA (8); RU (6); DE (4); KR (4); AR (6); ME (3); IL (5); NL (1); PE (2); IT (3); FR (3); CL (3); PL (9)