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

Completed · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Disease, Chronic Obstructive

In brief

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

Key facts

Study ID

NCT00606684

Run by

GlaxoSmithKline

People needed

602

Starts

2008-02-01

Expected to finish

2008-10-01

Last updated by the study team

2016-12-16

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

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.
• Tobacco Use: Must have current or prior history of at least 10 pack-years of cigarette smoking. [number of pack years = (number of cigarettes per day / 20) x number of years smoked (e.g., 20 cigarettes per day for 10 years, or 10 cigarettes per day for 20 years]. Previous smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1.
• Severity of Disease:
• Subjects with a measured post-salbutamol FEV1/FVC ratio of ≤0.70 at Visit 1 (Screening).
• Subjects with a measured post-salbutamol FEV1 ≥35 and ≤70% of predicted normal values calculated using NHANES III reference equations at Visit 1 (Screening).

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.
• 12-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)
• Clinically significant arrhythmias (e.g., atrial fibrillation, ventricular tachycardia)
• The investigator will determine the clinical significance of any ECG abnormality and determine if a subject is precluded from entering the study. However, the following predetermined ECG abnormalities are considered clinically significant and will result in exclusion of a subject:
• A mean QTc(B) value at screening >450msec, or uncorrected QT>600msec or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T wave)
• Ventricular rate < 45 beats per minute.
• PR interval > 240msec.
• Evidence of second or third degree atrioventricular (AV) block
• Pathological Q waves
• Non-specific intraventricular conduction delay
• ST-T wave abnormalities (excluding non-specific ST-T wave abnormalities)
• Right or left complete bundle branch block

Where it is running

• GSK Investigational Site — Jasper, Alabama, United States
• GSK Investigational Site — Montgomery, Alabama, United States
• GSK Investigational Site — Fullerton, California, United States
• GSK Investigational Site — Lakewood, California, United States
• GSK Investigational Site — Los Angeles, California, United States
• GSK Investigational Site — Rancho Mirage, California, United States
• GSK Investigational Site — Sepuldeva, California, United States
• GSK Investigational Site — Upland, California, United States
• GSK Investigational Site — Newark, Delaware, United States
• GSK Investigational Site — Brandon, Florida, United States
• GSK Investigational Site — DeLand, Florida, United States
• GSK Investigational Site — Miami, Florida, United States
• GSK Investigational Site — Tampa, Florida, United States
• GSK Investigational Site — Marietta, Georgia, United States
• GSK Investigational Site — Carmel, Indiana, United States
• GSK Investigational Site — Elkhart, Indiana, United States
• GSK Investigational Site — New Albany, Indiana, United States
• GSK Investigational Site — Lafayette, Louisiana, United States
• GSK Investigational Site — Sunset, Louisiana, United States
• GSK Investigational Site — Detroit, Michigan, United States
• GSK Investigational Site — Livonia, Michigan, United States
• GSK Investigational Site — Saint Charles, Missouri, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — St Louis, Missouri, United States
• GSK Investigational Site — Florence, Alabama, United States

Full record on ClinicalTrials.gov

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