Chronic Obstructive Pulmonary Disease (COPD) MedDRA version: 14.1 Level: LLT Classification code 10010952 Term: COPD System Organ Class: 100000004855
Conditions
Interventions
Product Name: Umeclidinium Bromide (UMEC)
Product Code: GSK573719
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: GSK573719
Current Sponsor code: GSK573719
Concentration uni
Sponsors
GlaxoSmithKline Research & Development Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Type of subject: Outpatient. 2. Informed Consent: A signed and dated written informed consent prior to study participation. 3. Age: Subjects 40 years of age or older at Visit 1. 4. Gender: Male or female subjects. A female is eligible to enter and participate in the study if she is of: Non-child bearing potential OR Child bearing potential agreeing to one of the following contraceptive methods: • Abstinence • Oral Contraceptive, either combined or progestogen alone • Injectable progestogen • Implants of levonorgestrel • Estrogenic vaginal ring • Percutaneous contraceptive patches • Intrauterine device (IUD) or intrauterine system (IUS) that meets the SOP effectiveness criteria as stated in the product label • Male partner sterilization (vasectomy with documentation of azoospermia) prior to the female subject's entry into the study, and this male is the sole partner for that subject. For this definition, “documented” refers to the outcome of the investigator's/designee’s medical examination of the subject or review of the subject's medical history for study eligibility, as obtained via a verbal interview with the subject or from the subject’s medical records. • Double barrier method: condom and an occlusive cap (diaphragm or cervical/vault caps) with a vaginal spermicidal agent (foam/gel/film/cream/suppository). 5. Diagnosis: An established clinical history of COPD in accordance with the definition by the American Thoracic Society/European Respiratory Society. 6. Smoking History: Current or former cigarette smokers with a history of cigarette smoking of =10 pack-years [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)]. Former smokers are defined as those who have stopped smoking for at least 6 months prior to Visit 1. Pipe and/or cigar use cannot be used to calculate pack year history. 7. Severity of Disease: A pre and post-albuterol/salbutamol FEV1/FVC ratio of =65 years) yes F.1.3.1 Number of subjects for this age range 100
Exclusion criteria
Exclusion criteria: 1. Pregnancy: Women who are pregnant or lactating or are planning on becoming pregnant during the study. 2. Asthma: A current diagnosis of asthma. 3. Other Respiratory Disorders: Known a-1 antitrypsin deficiency, active lung infections (such as tuberculosis), and lung cancer are absolute exclusionary conditions. A subject who, in the opinion of the investigator, has any other significant respiratory conditions in addition to COPD should be excluded. Examples may include clinically significant bronchiectasis, pulmonary hypertension, sarcoidosis, or interstitial lung disease. 4. Other Diseases/Abnormalities: Subjects with historical or current evidence of clinically significant cardiovascular, neurological, psychiatric, renal, hepatic, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or hematological abnormalities that are uncontrolled and/or a previous history of cancer in remission for <5 years prior to Visit 1 (localized carcinoma of the skin that has been resected for cure is not exclusionary). Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through participation, or which would affect the efficacy or safety analysis if the disease/condition exacerbated during the study. 5. Contraindications: Any history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist, sympathomimetic, corticosteroid (intranasal, inhaled or systemic) lactose/milk protein or magnesium stearate, or a medical condition such as narrow-angle glaucoma, prostatic hypertrophy or bladder neck obstruction that, in the opinion of the study physician contraindicates study participation or use of an inhaled anticholingeric. 6. Hospitalization: Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1. 7. Lung Resection: Subjects with lung volume reduction surgery within the 12 months prior to Visit 1. 8. 12-Lead ECG: An abnormal and significant ECG finding from the 12-lead ECG conducted at Visit 1. Investigators will be provided with ECG reviews conducted by a centralized independent cardiologist to assist in evaluation of subject eligibility. Specific ECG findings that preclude subject eligibility are listed in Appendix 4 of the study protocol. The study investigator will determine the medical significance of any ECG abnormalities not listed in Appendix 4 of the study protocol. 9. Medication Prior to Spirometry: Unable to withhold albuterol/salbutamol for the 4 our period required prior to spirometry testing at each study visit. 10. Medications Prior to Screening: Use of the following medications according to the following defined time intervals prior to Visit 1: *Please see table listed within study protocol, p20. 11. Oxygen: Use of long-term oxygen therapy (LTOT) described as oxygen therapy prescribed for greater than 12 hours a day. As-needed oxygen use (i.e., =12 hours per day) is not exclusionary. 12. Nebulized Therapy: Regular use (prescribed for use every day, not for as-needed use) of short-acting bronchodilators (e.g., albuterol/salbutamol) via nebulized therapy. 13. Pulmonary Rehabilitation Program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded. 14. Drug or Alcohol Abuse: A known or suspected history of alcohol or drug abuse within 2
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to compare the efficacy and safety of the addition of UMEC (62.5mcg) once-daily to FSC (250/50mcg) twice-daily, UMEC (125mcg) once-daily to FSC (250/50mcg) twice-daily with placebo to FSC (250/50mcg) twice-daily over 12 weeks for the treatment of subjects with COPD.;Secondary Objective: The secondary objective is to compare the effect of the addition of UMEC (62.5mcg) once-daily to FSC (250/50mcg) twice-daily, UMEC (125mcg) once-daily to FSC (250/50mcg) twice-daily with placebo to FSC (250/50mcg) twice-daily on COPD-related health status assessments over 12 weeks in subjects with COPD.;Primary end point(s): The primary endpoint is trough FEV1 on treatment day 85. ;Timepoint(s) of evaluation of this end point: Visit 7/ Day 85 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 0-6 hour weighted mean FEV1 Rescue albuterol/salbutamol usage ;Timepoint(s) of evaluation of this end point: Visit 6 / Day 84 Summary at end of the 12 week treatment period | — |
Countries
Chile, Czech Republic, Korea, Republic of, Poland, Romania, United States
Contacts
Public ContactGSK Clinical Support HelpDesk
GlaxoSmithKline Research & Development Limited
Outcome results
None listed