EUCTR2009-016690-15-DEActive, not recruitingNot Applicable
A randomized, double-blind, parallel-group, placebo-controlledstudy to evaluate the efficacy and safety of GSK573719delivered once-daily over 28 days in subjects with COPD
GlaxoSmithKline Research and Development LTD0 sites264 target enrollmentStarted: November 23, 2009Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 264
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
Inclusion Criteria
- •1. Informed Consent: A signed and dated written informed consent prior to study
- •participation.
- •2. Gender: Male or female adults.
- •A female is eligible to enter and participate in this study if she is of non-childbearing
- •potential (i.e., physiologically incapable of becoming pregnant), including any
- •female who is post-menopausal. If indicated, menopause can be confirmed by serum
- •follicle stimulating hormone (FSH) levels >40 mIU/mL and estradiol <40pg/mL
- •(<140 pmol/L).
- •3. Age: 40 to 80 years of age, inclusive, at Visit 1
- •4. Diagnosis: An established clinical history of COPD in accordance with the
- •definition by the American Thoracic Society/European Respiratory Society
- •[Celli, 2004] as follows:
- •Chronic obstructive pulmonary disease is a preventable and treatable disease state
- •characterized by airflow limitation that is not fully reversible. The airflow limitation
- •is usually progressive and is associated with an abnormal inflammatory response ofthe lungs to noxious particles or gases, primarily caused by cigarette smoking.
- •Although COPD affects the lungs, it also produces significant systemic
- •consequences.
- •5. Smoking History: Current or previous cigarette smokers with a history of cigarette
- •smoking of =10 pack-years at screening (Visit 1). Previous smokers are defined as
- •those who have stopped smoking for at least 6 months prior to Visit 1.
- •Number of pack years = (number of cigarettes per day / 20) x number of years
- •smoked (e.g., 20 cigarettes per day for 10 years = 10 pack years, or 10 cigarettes per day for 20 years = 10 pack years).
- •6. Severity of Disease: A post-albuterol/salbutamol FEV1/FVC ratio of =0.70 and a
- •post-albuterol/salbutamol FEV1 of =35 and =70% of predicted normal values at Visit
- •1 (Screening) calculated using NHANES III reference equations [Hankinson, 1999].
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
Exclusion Criteria
- •1. Asthma: A current diagnosis of asthma.
- •2. Other Respiratory Disorders: Known respiratory disorders other than COPD
- •including but not limited to a-1 antitrypsin deficiency, active tuberculosis, lung
- •cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, and
- •interstitial lung disease. Allergic rhinitis is not exclusionary.
- •3. Lung Resection: Any previous lung resection surgery (e.g., lung volume reduction
- •surgery or lobectomy)
- •4. Chest X-Ray: A chest X-ray or computed tomography (CT) scan which reveals
- •evidence of clinically significant abnormalities not believed to be due to the presence
- •of COPD. A chest X-ray must be taken at Visit 1 if a chest X-ray or CT scan is not
- •available within 6 months prior to Visit 1. For subjects in Germany, if a chest X-ray
- •(or CT scan) is not available in the 6 months prior to Visit 1 the subject will not be
- •eligible for the study.
- •5. COPD Medications: Use of oral corticosteroids or antibiotics for an exacerbation of
- •COPD or a lower respiratory tract infection within 6 weeks prior to Visit 1.
- •6. Hospitalization: Hospitalization for COPD or pneumonia within 3 months prior to
- •7. Other Diseases/Abnormalities: Any significant disease that, in the opinion of the
- •investigator, would put the safety of the subject at risk through study participation, or which would affect the efficacy analysis if the disease/condition exacerbated during
- •8. Morbid Obesity: A body mass index (BMI) value of >35kg/m2.
- •9. Pacemaker: The presence of a paced rhythm on a 12-lead electrocardiogram (ECG)
- •which causes the underlying rhythm and ECG to be obscured.
- •10. 12-Lead ECG: A significantly abnormal 12-lead ECG that results in an active
- •medical problem. For the purposes of this study, a significantly abnormal ECG that
- •would preclude a subject from entering the trial is defined as a 12-lead tracing which
- •is interpreted with, but not limited to, any of the following:
- •i. Sinus bradycardia <45 beats per minute (bpm) or sinus tachycardia =110 bpm
- •ii. Multifocal atrial tachycardia (wandering atrial pacemaker with rate >100 bpm)
- •iii. PR interval >240msec
- •iv. Evidence of Mobitz II second degree or third degree atrioventricular (AV) block
- •v. Pathological Q waves (defined as wide [>0.04 seconds] and deep [>0.4 mV
- •(4mm with 10 mm/mV setting)] or >25% of the height of the corresponding R
- •wave, providing the R wave was >0.5 mV [5 mm with 10 mm/mV setting],
- •appearing in at least two contiguous leads.
- •Note: prior evidence (i.e., ECG obtained at least 12 months prior) of
- •pathological QT waves that are unchanged are not exclusionary.
- •vi. Evidence of ventricular ectopic couplets, bigeminy, trigeminy or multifocal
- •premature ventricular complexes.
- •vii. QTc(F) =450 msec or uncorrected QT > 600 msec or an ECG that is unsuitable
- •for QT measurements (e.g., poor defined termination of the T wave)
- •Note: QTc(F) =450 msec or uncorrected QT >600 msec should be confirmed by
- •three readings at least 5 minutes apart.
- •viii. ST-T wave abnormalities (excluding non-specific ST-T wave abnormalities)
- •ix. Right or left complete bundle branch block
- •x. Clinically significant conduction abnormalities (e.g., left bundle branch block,
- •Wolff-Parkinson-White syndrome)
- •xi. Clinically significant arrhythmias (e.g., atrial fibrillation with rapid ventricular
- •response, ventricular tachycardia)
- •Investigators will be provided with ECG reviews conducted by an independent
- •cardiologist to assist in evaluation of subject eligibility.
Investigators
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