A Study To Assess Efficacy And Safety Of Different Doses Of GW642444 In Subjects With Chronic Obstructive Pulmonary Disease (COPD)

NCT00606684 | Completed Phase 2 Results

• 1 other identifier: B2C111045
• Study Type: interventional
• Target: 602
• Locations: 14 countries
• Sites: 99

Brief Summary

This study will assess the safety and efficacy of 5 doses GW642444 in subjects with Chonic Obstructive Pulmonary Disease (COPD)

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

Chronic Obstructive Pulmonary Disease (COPD); COPD; GW642444

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Trough (Pre Bronchodilator and Pre Dose) FEV1 on Day 29

  Pulmonary function was measured by forced expiratory volume in one second (FEV1), defined as the maximal amount of air that can be forcibly exhaled from the lungs in one second. Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. If one of these two assessments was missing then Baseline is defined as the single pre-dose FEV1 value at Day 1. The trough FEV1 is defined as the mean of the FEV1 values obtained at 23 and 24-hours after dosing on Day 28 and the Baseline FEV1 is defined as the mean of the two assessments made 30 minutes pre-dose and immediately pre-dose on Day 1. Change from Baseline in trough FEV1 was calculated as the value on Day 29 minus the value at Baseline. Analysis was performed using Analysis of Covariance (ANCOVA) using Last Observation Carried Forward (LOCF) with covariates of baseline, sex, age, smoking status (at screening), reversibility stratum, and treatment (trt).

  Baseline (BL) and Day 29

Secondary Outcomes (3)

• Time-adjusted Area Under the Curve (AUC) (i.e. Weighted Mean Change From Baseline) for 24 Hour Serial FEV1 on Days 1 and 28

  Baseline to Day 28

• Time to >= 12% Increase From Baseline in FEV1 (0-4 Hours Post-dose)

  Baseline and Day 1

• Time to >= 100 Milliliter (mL) Increase From Baseline in FEV1 (0-4 Hours Post-dose)

  Baseline and Day 1

Study Arms (2)

GW642444

ACTIVE COMPARATOR

GW642444

Drug: GW642444 6.25; Drug: GW642444 3mcg; Drug: GW642444 12.5mcg; Drug: GW642444 25mcg; Drug: GW642444 50mcg

placebo

PLACEBO COMPARATOR

Other: placebo

Interventions

GW642444 6.25 DRUG

GW642444 6.25

GW642444

GW642444 3mcg DRUG

once daily

Also known as: GW642444

GW642444

GW642444 12.5mcg DRUG

GW642444 12.5mcg

GW642444

GW642444 25mcg DRUG

GW642444 25mcg

GW642444

GW642444 50mcg DRUG

GW642444 50mcg

GW642444

placebo OTHER

placebo

placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects eligible for enrollment in the study must meet all of the following criteria:
• Informed Consent: Subjects who give their signed written informed consent to participate.
• Gender: Male or females who are 40 - 80 years of age at Visit 1. A female is eligible to enter and participate in the study if she is of:
• Non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal); or
• Child bearing potential, has a negative pregnancy test at screening, and agrees to one of the following acceptable contraceptive methods used consistently and correctly (i.e. in accordance with the approved product label and the instructions of the physician for the duration of the study - screening to follow-up contact):
• Complete abstinence from intercourse from screening until 2 weeks after the follow-up contact; or
• Male partner is sterile (vasectomy with documentation of azoospermia) prior to female subject entry into the study, and this male partner is the sole partner for that subject; or
• Implants of levonorgestrel inserted for at least 1 month prior to the study medication administration but not beyond the third successive year following insertion; or
• Injectable progestogen administered for at least 1 month prior to study medication administration and administered for 1 month following study completion; or
• Oral contraceptive (combined or progestogen only) administered for at least one monthly cycle prior to study medication administration; or
• Double barrier method: condom or occlusive cap (diaphragm or cervical/vault caps) plus spermicidal agent (foam/gel/film/cream/suppository); or
• An intrauterine device (IUD), inserted by a qualified physician, with published data showing that the highest expected failure rate is less than 1% per year; or
• Estrogenic vaginal ring; or
• Percutaneous contraceptive patches
• COPD Diagnosis: Subjects with an established clinical history of COPD in accordance with the following definition by the American Thoracic Society/European Respiratory Society \[Celli, 2004\]: COPD is a preventable and treatable disease characterised by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences.

You may not qualify if:

• Subjects meeting any of the following criteria must not be enrolled in the study:
• Pregnancy: Women who are pregnant or lactating.
• Asthma: Subjects with a primary diagnosis of asthma. (Subjects with a prior history of asthma are eligible if COPD is currently their primary diagnosis)
• a1-antitrypsin deficiency: Subjects with a1-antitrypsin deficiency as the underlying cause of COPD.
• Other Respiratory disorders: Subjects with active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease or other active pulmonary disease.
• Lung Resection: Subjects with lung volume reduction surgery within the previous 12 months.
• Chest X-ray: Chest X-ray (or CT scan) reveals evidence of clinically significant abnormalities not believed to be due to the presence of COPD. A chest x-ray must be taken if a chest x-ray or CT scan is not available within the 6 months preceding the Screening Visit. For sites in Germany, if a chest x-ray (or CT scan) is not available in the 6 months preceding the Screening (Visit 1), the subject will not be eligible for the study.
• Hospitalization: Subjects who are hospitalized due to poorly controlled COPD within 12 weeks of the screening visit.
• Poorly controlled COPD: Subjects with poorly controlled COPD, defined as the occurrence of any of the following in the 6 weeks prior to Visit 1:
• acute worsening of COPD that is managed by subject with corticosteroids or antibiotics, or
• acute worsening of COPD that requires treatment prescribed by a physician
• Other Diseases/Abnormalities: Subjects with clinically significant cardiovascular neurological, psychiatric, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled.
• Lower Respiratory Tract Infection: Subjects with lower respiratory tract infections which required the use of antibiotics within 6 weeks prior to visit 1.
• Lead ECG: An abnormal and clinically significant 12-lead electrocardiogram (ECG) that results in an active medical problem. For the purposes of this study, an abnormal ECG is defined as a 12-lead tracing which is interpreted with (but not limited to) any of the following:
• Clinically significant conduction abnormalities (e.g., left bundle branch block, Wolff-Parkinson-White syndrome)

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (99)

GSK Investigational Site

Florence, Alabama, 35630, United States

Location

GSK Investigational Site

Jasper, Alabama, 35501, United States

Location

GSK Investigational Site

Montgomery, Alabama, 36109, United States

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GSK Investigational Site

Fullerton, California, 92835, United States

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GSK Investigational Site

Lakewood, California, 90712, United States

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GSK Investigational Site

Los Angeles, California, 90095-1752, United States

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GSK Investigational Site

Rancho Mirage, California, 92270, United States

Location

GSK Investigational Site

Sepuldeva, California, 91343, United States

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GSK Investigational Site

Upland, California, 91786, United States

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GSK Investigational Site

Newark, Delaware, 19713, United States

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GSK Investigational Site

Brandon, Florida, 33511, United States

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GSK Investigational Site

DeLand, Florida, 32720, United States

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GSK Investigational Site

Miami, Florida, 33136, United States

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GSK Investigational Site

Tampa, Florida, 33613, United States

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GSK Investigational Site

Marietta, Georgia, 30060, United States

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GSK Investigational Site

Carmel, Indiana, 46032, United States

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GSK Investigational Site

Elkhart, Indiana, 46515, United States

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GSK Investigational Site

New Albany, Indiana, 47150, United States

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GSK Investigational Site

Lafayette, Louisiana, 70503, United States

Location

GSK Investigational Site

Sunset, Louisiana, 70584, United States

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GSK Investigational Site

Detroit, Michigan, 48201-2018, United States

Location

GSK Investigational Site

Livonia, Michigan, 48152, United States

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GSK Investigational Site

Saint Charles, Missouri, 63301, United States

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GSK Investigational Site

St Louis, Missouri, 63122, United States

Location

GSK Investigational Site

St Louis, Missouri, 63141, United States

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GSK Investigational Site

Butte, Montana, 59701, United States

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GSK Investigational Site

Summit, New Jersey, 07091, United States

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GSK Investigational Site

Elmira, New York, 14901, United States

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GSK Investigational Site

Larchmont, New York, 10538, United States

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GSK Investigational Site

Charlotte, North Carolina, 28207, United States

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GSK Investigational Site

Greenville, North Carolina, 27834, United States

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GSK Investigational Site

Raleigh, North Carolina, 27607, United States

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GSK Investigational Site

Statesville, North Carolina, 28625, United States

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GSK Investigational Site

Cincinnati, Ohio, 45231, United States

Location

GSK Investigational Site

Medford, Oregon, 97504, United States

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GSK Investigational Site

Portland, Oregon, 97220, United States

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GSK Investigational Site

Philadelphia, Pennsylvania, 19140, United States

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GSK Investigational Site

Charleston, South Carolina, 29406-7108, United States

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GSK Investigational Site

Gaffney, South Carolina, 29340, United States

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GSK Investigational Site

Greenville, South Carolina, 29615, United States

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GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

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GSK Investigational Site

Union, South Carolina, 29379, United States

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GSK Investigational Site

Corsicana, Texas, 75110, United States

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GSK Investigational Site

Dallas, Texas, 75216, United States

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GSK Investigational Site

Houston, Texas, 77030, United States

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GSK Investigational Site

Waco, Texas, 76712, United States

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GSK Investigational Site

South Burlington, Vermont, 05403, United States

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GSK Investigational Site

Abingdon, Virginia, 24210, United States

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GSK Investigational Site

Richmond, Virginia, 23225, United States

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GSK Investigational Site

Vicente López, Buenos Aires, B1602DOH, Argentina

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GSK Investigational Site

Mendoza, Mendoza Province, M5500CCG, Argentina

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GSK Investigational Site

Buenos Aires, C1121ABE, Argentina

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GSK Investigational Site

Bathurst, New Brunswick, E2A 4X7, Canada

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GSK Investigational Site

Brampton, Ontario, L6T 3T1, Canada

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GSK Investigational Site

Saskatoon, Ontario, S7N 0W8, Canada

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GSK Investigational Site

Toronto, Ontario, M5G 1N8, Canada

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GSK Investigational Site

Gatineau, Quebec, J8Y 6S8, Canada

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GSK Investigational Site

Montreal, Quebec, H3H 2R9, Canada

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GSK Investigational Site

Valparaíso, Región de Valparaíso, 2341131, Chile

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GSK Investigational Site

Santiago, Región Metro de Santiago, 7500551, Chile

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GSK Investigational Site

Hellerup, 2900, Denmark

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GSK Investigational Site

Hvidovre, 2650, Denmark

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GSK Investigational Site

Odense C, 5000, Denmark

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GSK Investigational Site

Tallinn, 13419, Estonia

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GSK Investigational Site

Tallinn, 13619, Estonia

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GSK Investigational Site

Tartu, 51014, Estonia

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GSK Investigational Site

Landsberg am Lech, Bavaria, 86899, Germany

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GSK Investigational Site

Munich, Bavaria, 80539, Germany

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GSK Investigational Site

Rüdersdorf, Brandenburg, 15562, Germany

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GSK Investigational Site

Leipzig, Saxony, 04103, Germany

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GSK Investigational Site

Magdeburg, Saxony-Anhalt, 39112, Germany

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GSK Investigational Site

Geesthacht, Schleswig-Holstein, 21502, Germany

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GSK Investigational Site

Berlin, State of Berlin, 14057, Germany

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GSK Investigational Site

Schmölln, Thuringia, 04626, Germany

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GSK Investigational Site

Zapopan, Jalisco, 45040, Mexico

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GSK Investigational Site

Monterrey NL, Nuevo León, 64718, Mexico

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GSK Investigational Site

Mexico City, 06720, Mexico

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GSK Investigational Site

México, 11550, Mexico

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GSK Investigational Site

Lima, Lima Province, Lima 1, Peru

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GSK Investigational Site

San Isidro, Lima region, Lima 27, Peru

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GSK Investigational Site

Lipa City, 4217, Philippines

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GSK Investigational Site

Manila, 1000, Philippines

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GSK Investigational Site

Quezon City, 1101, Philippines

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GSK Investigational Site

Gidle, 97-540, Poland

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GSK Investigational Site

Prabuty, 82-550, Poland

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GSK Investigational Site

Warsaw, 01-138, Poland

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GSK Investigational Site

Warsaw, 02-097, Poland

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GSK Investigational Site

Zabrze, 41-803, Poland

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GSK Investigational Site

Moscow, 105077, Russia

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GSK Investigational Site

Moscow, 125315, Russia

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GSK Investigational Site

Samara, 443079, Russia

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GSK Investigational Site

Saratov, 410053, Russia

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GSK Investigational Site

Smolensk, 214001, Russia

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GSK Investigational Site

Yekaterinburg, 620109, Russia

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GSK Investigational Site

Bratislava, 821 06, Slovakia

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GSK Investigational Site

Spišská Nová Ves, 052 01, Slovakia

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GSK Investigational Site

Šaľa, 927 01, Slovakia

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GSK Investigational Site

Seoul, 135-710, South Korea

Location

GSK Investigational Site

Seoul, 152-703, South Korea

Location

Related Publications (1)

• Hanania NA, Feldman G, Zachgo W, Shim JJ, Crim C, Sanford L, Lettis S, Barnhart F, Haumann B. The efficacy and safety of the novel long-acting beta2 agonist vilanterol in patients with COPD: a randomized placebo-controlled trial. Chest. 2012 Jul;142(1):119-127. doi: 10.1378/chest.11-2231.

  PMID: 22241764 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: January 18, 2008
• First Posted: February 4, 2008
• Study Start: February 1, 2008
• Primary Completion: October 1, 2008
• Study Completion: October 1, 2008
• Last Updated: December 16, 2016
• Results First Posted: September 17, 2013

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will share

Locations

CL (2); KR (2); SL (3); CA (6); ES (3); ME (4); PH (3); RU (6); AR (3); DK (3); US (49); DE (8); PE (2); PL (5)