Chronic obstructive pulmonary disease (COPD) MedDRA version: 20.0 Level: PT Classification code 10009033 Term: Chronic obstructive pulmonary disease System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Trade Name: Incruse
Product Name: umeclidinium bromide
Product Code: GSK573719
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: UMECLIDINIUM BROMIDE
CAS Number: 869113-09-7
Current Sponsor
Sponsors
GlaxoSmithKline Research & Development Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: A subject will be eligible for inclusion in this study only if all of the following criteria apply: AGE 1. 40 years or older at date of signing informed consent at Screening Visit 1. TYPE OF SUBJECT AND DIAGNOSIS INCLUDING DISEASE SEVERITY 2. Outpatient with a diagnosis of COPD. 3. FEV1: Persistent airflow limitations as indicated by: A pre and postalbuterol/ salbutamol FEV1/FVC ratio of =65 years) yes F.1.3.1 Number of subjects for this age range 606
Exclusion criteria
Exclusion criteria: A subject will not be eligible for inclusion in this study if any of the following criteria apply: CONCURRENT CONDITIONS/MEDICAL HISTORY (INCLUDES LIVER FUNCTION 1. Asthma 2. Alpha-antitrypsin deficiency 3. Other respiratory disorder 4. Unstable liver disease 5. Unstable or life threatening cardiac disease 6. 12 Lead ECG: 7. Antimuscarinic effects 8. Other disease abnormalities 9. Hospitalization 10. Inhaled corticosteroids (ICS) 11. Exacerbation 12. Other respiratory tract infections 13. Lung Resection 14. Oxygen (For detailed list, please refer to pages 27-29 of the study protocol) CONCOMITANT MEDICATIONS 1. Medications prior to Screening: Use of the following medications according to the following defined time intervals prior to Screening (Visit 1) (Please refer to table listed on page 29 of study protocol) 2. Medication prior to spirometry: Unable to withhold albuterol/salbutamol for the 4 hour period required prior to spirometry testing at each study visit. 3. Maintenance use of short-acting bronchodilators: Regular use (prescribed for daily/ regular use, not for as-needed use) of short-acting bronchodilators (e.g. albuterol/salbutamol). RELEVANT HABITS 1. Drug or alcohol abuse: A known or suspected history of alcohol or drug abuse within 2 years prior to Screening Visit 1 that in the opinion of the investigator would prevent the subject from completing the study procedures. CONTRAINDICATIONS 1. Any history of allergy or hypersensitivity to any anticholinergic/muscarinic receptor antagonist, sympathomimetic, lactose/milk protein or magnesium stearate. DIAGNOSTIC ASSESSMENTS AND OTHER CRITERIA 1. Pulmonary Rehabilitation program: Participation in the acute phase of a pulmonary rehabilitation program within 4 weeks prior to Screening Visit 1. Subjects who are in the maintenance phase of a pulmonary rehabilitation program are not excluded. 2. Affiliation with investigator sites: Is an investigator, sub-investigator, study coordinator, employee of a participating investigator or study site, or immediate family member of the aforementioned that is involved in this study 3. Inability to read: In the opinion of the investigator, any subject who is unable to read and/or would not be able to complete questionnaires on the electronic diary. Subjects who fail to meet inclusion and exclusion criteria at the Screening Visit 1 will be considered screen failures and cannot be re-screened.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the effect of UMEC/VI (62.5/25 mcg once daily) with UMEC (62.5 mcg once daily) on lung function.;Secondary Objective: To compare UMEC/VI (62.5/25 mcg once daily), UMEC (62.5 mcg once daily) with salmeterol (50 mcg twice daily) on patient reported outcomes (PROs).;Primary end point(s): Change from baseline in trough Forced Expiratory Volume in One Second (FEV1) at week 24;Timepoint(s) of evaluation of this end point: 24 weeks post treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To compare UMEC/VI (62.5/25 mcg once daily), UMEC (62.5 mcg once daily) with salmeterol (50 mcg twice daily) on patient reported outcomes (PROs);Timepoint(s) of evaluation of this end point: over 24 weeks of treatment | — |
Countries
Argentina, Australia, Canada, Germany, Italy, Mexico, Netherlands, South Africa, Spain, Sweden, United States
Contacts
Public ContactGSK Clinical Support Help Desk
GlaxoSmithKline Research and Development Ltd
Outcome results
None listed