Chronic Obstructive Pulmonary Disease MedDRA version: 12.0 Level: LLT Classification code 10009033 Term: Chronic obstructive pulmonary disease
Conditions
Interventions
Product Name: GSK573719
Product Code: GSK573719
Pharmaceutical Form: Inhalation powder, hard capsule
Current Sponsor code: GSK573719
Concentration unit: µg microgram(s)
Concentration type: equal
Conce
Sponsors
GlaxoSmithKline Research and Development LTD
Eligibility
Sex/Gender
All
Inclusion criteria
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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 Visit 1. 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 the study. 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 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. Please
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy and safety of three doses of GSK573719 (125, 250, and 500 mcg once daily) compared with placebo in subjects with COPD in order to inform the selection of an optimal effective and safe dose for future clinical development programs.;Secondary Objective: A secondary objective is to evaluate the pharmacokinetic profile of GSK573719 with repeat dosing in subjects with COPD over 28 days.;Primary end point(s): The primary endpoint is change from baseline in trough FEV1 at Day 29. Baseline is defined as the mean of the two pre-dose values obtained 30 minutes pre-dose and immediately pre-dose [time 0] on Day 1. Trough is defined as the mean of the FEV1 values obtained 23 and 24 hours after the dose administered on Day 28. | — |
Countries
Estonia, Germany, Poland
Outcome results
None listed