Clinical Trials List
Protocol Number200820
2014-05-01 - 2015-12-31
Phase III
Terminated5
ICD-10 J44.9
Chronic obstructive pulmonary disease, unspecified
ICD-9496
Chronic airways obstruction, not elsewhere classified
A 12-Week Study to Evaluate the Efficacy and Safety of Fluticasone Furoate/Vilanterol Inhalation Powder (FF/VI) 100/25 mcg Once Daily Compared with Vilanterol Inhalation Powder (VI) 25 mcg Once Daily in Subjects with Chronic Obstructive Pulmonary Disease (COPD)
-
Trial Applicant
GlaxoSmithKline
-
Sponsor
GlaxoSmithKline Research & Development Limited
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- 王振宇 Division of Thoracic Medicine
- 覃俊士 Division of Thoracic Medicine
- Wei- Chang Huang Division of Thoracic Medicine
- Ming -Cheng Chan Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chih-Ching Yen Division of Thoracic Medicine
- Bing-Ru Wu Division of Thoracic Medicine
- Chen Chia-Hung Division of Thoracic Medicine
- Yu-Chao Lin Division of Thoracic Medicine
- Chih-Yen Tu Division of Thoracic Medicine
- 梁信杰 Division of Thoracic Medicine
- Shuo-Chueh Chen Division of Thoracic Medicine
- Wei-Chun Chen Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 惠群 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 游騰仁 Division of Thoracic Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Chronic Obstructive Pulmonary Disease (COPD)
Objectives
Primary Objective
The primary objective of the study is to evaluate the contribution on lung function (as
measured by trough FEV1) of FF 100 mcg to FF/VI 100/25mcg QD by the comparison of
the latter with VI 25mcg QD (each administered via the ELLIPTA™ inhaler) and the
safety of FF/VI 100/25 mcg QD over a 12-week treatment period in subjects with COPD
Secondary Objective
Secondary objectives of the study are to:
Evaluate the effect of FF/VI 100/25 mcg QD compared with VI 25 mcg QD on
subject-recordings of rescue medication (albuterol [salbutamol]) use and
symptoms of COPD (breathlessness, cough and sputum production)
Evaluate the effect of FF/VI 100/25 mcg QD compared with VI 25 mcg QD on
health-related quality of life using the using the St. George’s Respiratory
Questionnaire – Chronic Obstructive Pulmonary Disorder (SGRQ-C)
Evaluate the effect of FF/VI 100/25 mcg QD compared with VI 25 mcg QD on
COPD health status using the COPD Assessment Test (CAT)
Test Drug
Fluticasone Furoate/Vilanterol
Active Ingredient
Fluticasone Furoate/Vilanterol
vilanterol
vilanterol
Dosage Form
inhalation powder
Dosage
100/25
25
25
Endpoints
Primary
Change from baseline in Clinic Visit trough (pre-bronchodilator and pre-dose) FEV1, (to
evaluate the contribution of FF) on Treatment Day 84 (Visit 7).
Trough FEV1 on Treatment Day 84 is defined as the mean of the FEV1 values obtained
23 and 24 hours after dosing on Treatment Day 83, measured at Visit 7.
Baseline FEV1 is the mean of the two assessments made 30 minutes pre-dose and
immediately pre-dose on Treatment Day 1.
Secondary
Percentage of rescue-free 24-hour periods over the entire 12-week Treatment
Period
Time to first moderate/severe COPD exacerbation
Change from baseline in Clinic Visit trough (pre-bronchodilator and pre-dose) FEV1, (to
evaluate the contribution of FF) on Treatment Day 84 (Visit 7).
Trough FEV1 on Treatment Day 84 is defined as the mean of the FEV1 values obtained
23 and 24 hours after dosing on Treatment Day 83, measured at Visit 7.
Baseline FEV1 is the mean of the two assessments made 30 minutes pre-dose and
immediately pre-dose on Treatment Day 1.
Secondary
Percentage of rescue-free 24-hour periods over the entire 12-week Treatment
Period
Time to first moderate/severe COPD exacerbation
Inclution Criteria
1. Type of subject: Outpatient
2. Informed consent: Subjects must give their signed and dated written informed
consent to participate.
3. Gender: Male subjects or female subjects
Female subjects must be post-menopausal or using a highly effective method for
avoidance of pregnancy. The decision to include or exclude women of childbearing
potential may be made at the discretion of the investigator in accordance with local
practice in relation to adequate contraception.
4. Age: 40 years of age at Screening (Visit 1)
5. COPD diagnosis: Subjects with a 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 characterized 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 is also
associated with significant systemic consequences.
6. Severity of disease:
Subjects with a measured post-albuterol (salbutamol) FEV1/FVC ratio of 0.70
at Screening (Visit 1)
Subjects with a measured post- albuterol (salbutamol) FEV1 ≥30 to 70% of
predicted normal values calculated (via standardized spirometry equipment
provided by a centralized vendor) using Global Lung Function Initiative (GLI)
2012 reference equations [Quanjer, 2012] at Screening (Visit 1)
Note: For reporting purposes, in addition to the Quanjer values, the
NHANES III predicted values [Hankinson, 1999; Hankinson, 2010] at
Screening (Visit 1) will be presented for consistency with previous Phase
IIIa-b studies with FF/VI in subjects with COPD.
Post-bronchodilator spirometry will be performed approximately 10-15 minutes after
the subject has self-administered 4 inhalations (i.e., total of 400mcg) of albuterol
(salbutamol) via an MDI with a valved-holding chamber. The study-provided
standardized spirometry equipment will calculate the FEV1/FVC ratio and FEV1
percent predicted values.
7. Tobacco use: Subjects with a current or prior history of 10 pack-years of cigarette
smoking at Screening (Visit 1). Former smokers are defined as those who have
stopped smoking for at least 6 months prior to Visit 1.
Note: Pipe and/or cigar use cannot be used to calculate pack-year history.
Number of pack years = (number of cigarette per day/20)) x number of years smoked
8. History of COPD exacerbation: A documented history (e.g., medical record
verification) of at least one COPD exacerbation in the 12 months prior to Screening
(Visit 1) that required either systemic/oral corticosteroids, antibiotics and/or
hospitalization
Note: Prior use of antibiotics alone does not qualify as an exacerbation history,
unless the use was associated with treatment of worsening symptoms of COPD,
such as increased dyspnea, cough or sputum volume, or sputum purulence (color),
onset or worsening of chest tightness. Subject verbal reports are not acceptable.
9. Current symptoms of COPD: A Subject Diary combined symptom score
(combination of breathlessness, cough, sputum, and nighttime awakenings requiring
treatment with albuterol [salbutamol]) of ≥4 on at least 5 of the 7 days immediately
preceding Visit 2 (Randomization)
10. QTc Criteria: QTc <450msec or QTc <480msec for patients with bundle branch
block.
The QTc is the QT interval corrected for heart rate according to either Bazett’s
formula (QTcB), Fridericia’s formula (QTcF), or another method, machine or
manual overread.
For eligibility and withdrawal, ideally the same QT correction formula will be
used for all subjects. However, because this is not always possible, the same QT
correction formula must be used for each individual subject to determine
eligibility for and withdrawal from the study.
The specific formula that will be used to determine eligibility and
withdrawal for an individual subject should be determined prior to
initiation of the study. Note that the QT correction formula used is usually site-dependent since not all ECG machines are programmed
by the manufacturer with the same formula.
The QTc should be based on single or averaged QTc values of triplicate
electrocardiograms (ECGs) obtained over a brief recording period.
2. Informed consent: Subjects must give their signed and dated written informed
consent to participate.
3. Gender: Male subjects or female subjects
Female subjects must be post-menopausal or using a highly effective method for
avoidance of pregnancy. The decision to include or exclude women of childbearing
potential may be made at the discretion of the investigator in accordance with local
practice in relation to adequate contraception.
4. Age: 40 years of age at Screening (Visit 1)
5. COPD diagnosis: Subjects with a 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 characterized 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 is also
associated with significant systemic consequences.
6. Severity of disease:
Subjects with a measured post-albuterol (salbutamol) FEV1/FVC ratio of 0.70
at Screening (Visit 1)
Subjects with a measured post- albuterol (salbutamol) FEV1 ≥30 to 70% of
predicted normal values calculated (via standardized spirometry equipment
provided by a centralized vendor) using Global Lung Function Initiative (GLI)
2012 reference equations [Quanjer, 2012] at Screening (Visit 1)
Note: For reporting purposes, in addition to the Quanjer values, the
NHANES III predicted values [Hankinson, 1999; Hankinson, 2010] at
Screening (Visit 1) will be presented for consistency with previous Phase
IIIa-b studies with FF/VI in subjects with COPD.
Post-bronchodilator spirometry will be performed approximately 10-15 minutes after
the subject has self-administered 4 inhalations (i.e., total of 400mcg) of albuterol
(salbutamol) via an MDI with a valved-holding chamber. The study-provided
standardized spirometry equipment will calculate the FEV1/FVC ratio and FEV1
percent predicted values.
7. Tobacco use: Subjects with a current or prior history of 10 pack-years of cigarette
smoking at Screening (Visit 1). Former smokers are defined as those who have
stopped smoking for at least 6 months prior to Visit 1.
Note: Pipe and/or cigar use cannot be used to calculate pack-year history.
Number of pack years = (number of cigarette per day/20)) x number of years smoked
8. History of COPD exacerbation: A documented history (e.g., medical record
verification) of at least one COPD exacerbation in the 12 months prior to Screening
(Visit 1) that required either systemic/oral corticosteroids, antibiotics and/or
hospitalization
Note: Prior use of antibiotics alone does not qualify as an exacerbation history,
unless the use was associated with treatment of worsening symptoms of COPD,
such as increased dyspnea, cough or sputum volume, or sputum purulence (color),
onset or worsening of chest tightness. Subject verbal reports are not acceptable.
9. Current symptoms of COPD: A Subject Diary combined symptom score
(combination of breathlessness, cough, sputum, and nighttime awakenings requiring
treatment with albuterol [salbutamol]) of ≥4 on at least 5 of the 7 days immediately
preceding Visit 2 (Randomization)
10. QTc Criteria: QTc <450msec or QTc <480msec for patients with bundle branch
block.
The QTc is the QT interval corrected for heart rate according to either Bazett’s
formula (QTcB), Fridericia’s formula (QTcF), or another method, machine or
manual overread.
For eligibility and withdrawal, ideally the same QT correction formula will be
used for all subjects. However, because this is not always possible, the same QT
correction formula must be used for each individual subject to determine
eligibility for and withdrawal from the study.
The specific formula that will be used to determine eligibility and
withdrawal for an individual subject should be determined prior to
initiation of the study. Note that the QT correction formula used is usually site-dependent since not all ECG machines are programmed
by the manufacturer with the same formula.
The QTc should be based on single or averaged QTc values of triplicate
electrocardiograms (ECGs) obtained over a brief recording period.
Exclusion Criteria
1. Pregnancy: Women who are pregnant or lactating or are planning on becoming
pregnant during the study.
2. Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history
of asthma are eligible if they have a current diagnosis of COPD).
3. Other respiratory disorders: Subjects with 1-antitrypsin deficiency as the
underlying cause of COPD as the underlying cause of COPD, active tuberculosis,
lung cancer, bronchiectasis (Note: focal bronchiectasis is not exclusionary),
sarcoidosis, pulmonary fibrosis (Note: focal fibrotic pulmonary lesions are not
exclusionary), primary pulmonary hypertension, interstitial lung diseases, or other
active pulmonary diseases.
4. Lung resection: Subjects with lung volume reduction surgery within the 12 months
prior to Screening (Visit 1).
5. Chest X-ray (or CT scan): Subjects with a chest X-ray (or CT scan) that reveals
evidence of clinically significant abnormalities not believed to be due to the presence
of COPD. A chest X-ray must be taken at Screening (Visit 1) if a chest X-ray or CT
scan is not available within 1 year prior to Screening (Visit 1). For sites in
Germany: if a chest X-ray (or CT scan) within 1 year of Screening (Visit 1) is not
available, approval to conduct a diagnostic chest X-ray (CT scan) will need to be
obtained from the Federal Office for Radiation Protection (BfS).
6. Hospitalization: Subjects who are hospitalized due to poorly controlled COPD that
has not resolved at least 4 weeks prior to Screening (Visit 1) and at least 6 weeks
following the last dose of systemic corticosteroids.
7. Poorly controlled COPD: Subjects with poorly controlled COPD, defined as the
occurrence of any of the following in the 6 weeks prior to Screening (Visit 1):
Acute worsening of COPD that is managed by subject with systemic
corticosteroids or antibiotics or that requires treatment prescribed by a physician.
8. Lower respiratory tract infection: Subjects with lower respiratory tract infection
that required the use of antibiotics within 6 weeks prior to Screening (Visit 1).
9. COPD exacerbation/lower respiratory tract infection during Run-In Period:
Subjects who experience a moderate/severe COPD exacerbation (See definition in
“COPD Exacerbations and Pneumonia” Section 6.2.6) and/or a lower respiratory tract
infection (including pneumonia) during the Run-In Period.Note: Subjects who
experience a moderate/severe exacerbation and/or pneumonia during the Run-In
period must not be randomized at the randomization visit (Visit 2), but may be rescreened at a later time provided that the COPD exacerbation and/or pneumonia has
resolved prior to the re-screening visit. At the re-screening visit, chest x-ray should
confirm resolution of pneumonia. The re-screening visit must be conducted at least 6
weeks following the resolution date of the exacerbation and/or pneumonia and at least
6 weeks following the last dose of systemic corticosteroids (if applicable).
10. Abnormal clinically significant laboratory finding: Subjects who have an
abnormal clinical significant finding in any liver chemistry test at Screening (Visit 1)
or upon repeat prior to randomization.
11. Abnormal clinically significant 12-Lead ECG at Screening (Visit 1): Subjects who
have an abnormal, clinically significant ECG finding at Screening (Visit 1) or upon
repeat prior to randomization.
12. Other diseases/abnormalities: Subjects with historical or current evidence of
clinically significant and unstable disease such as cardiovascular (e.g., patients
requiring ICD, pacemaker requiring a rate set >60bpm, uncontrolled hypertension,
New Your Heart Association Class IV [New York Heart Association, 1994], known
left ventricular ejection fraction <30%) neurological, psychiatric, renal, hepatic,
immunological, endocrine (including uncontrolled diabetes or thyroid disease), peptic
ulcer disease, or hematological abnormalities. 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.
13. Liver Disease: Subjects who have unstable liver disease (as defined by the presence
of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric
varices or persistent jaundice), cirrhosis, known biliary abnormalities (with the
exception of Gilbert’s syndrome or asymptomatic gallstones)
14. Cancer: Subjects with carcinoma that has not been in complete remission for at least
5 years. Carcinoma in situ of the cervix, squamous cell carcinoma and basal cell
carcinoma of the skin would not be excluded if the subject has been considered cured
within 5 years since diagnosis.
15. Contraindications: Subjects with a history of allergy or hypersensitivity to any of
the study medications (e.g. beta-agonists, corticosteroids) or components of the
inhalation powder (e.g., lactose, magnesium stearate). In addition, subjects with a
history of severe milk protein allergy that, in the opinion of the investigator,
contraindicates the subject’s participation will also be excluded.
16. Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug
abuse within the last 2 years
17. Medication prior to spirometry: Subjects who are medically unable to withhold
their albuterol (salbutamol) or their ipratropium bromide for the 4-hour period
required prior to spirometry testing at each study visit.
18. Additional medication: Use of the following medications within the following time
intervals prior to Screening (Visit 1) or during the study.
19. Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy
(LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day.
Oxygen prn use (i.e., 12 hours per day) is not exclusionary.
20. Sleep apnea: Subjects with clinically significant sleep apnea who require use of
continuous positive airway pressure (CPAP) device or non-invasive positive pressure
ventilation (NIPPV).
21. Pulmonary rehabilitation: Subjects who have participated in the acute phase of a
Pulmonary Rehabilitation Program within 4 weeks prior to Screening (Visit 1) or who
will enter the acute phase of a Pulmonary Rehabilitation Program during the study.
Subjects who are in the maintenance phase of a Pulmonary Rehabilitation Program
are not excluded.
22. Non-Compliance during Run-In Period: Failure to demonstrate adequate
compliance defined as completion of Diary Card (completed all diary entries on at
least 5 of the last 7 consecutive days), the ability to withhold anti-COPD medications
and to keep clinic visit appointments. In addition, subjects must have recorded the
Run-In study medication use on at least 5 of the last 7, consecutive days of the Run-In
period to continue in the study.
23. Potential of non-compliance: Subjects at risk of non-compliance, or unable to
comply with the study procedures. Any infirmity, disability, or geographic location
that would limit compliance for scheduled visits.
24. Questionable validity of consent: Subjects with a history of psychiatric disease,
intellectual deficiency, poor motivation or other conditions that will limit the validity
of informed consent to participate in the study.
25. Prior use of study medication/other investigational drugs: Subjects who have
received an investigational drug within 30 days of entry into this study (Screening), or
within 5 drug half-lives of the investigational drug, whichever is longer.
26. Affiliation with investigator site: Study investigators, sub-investigators, study
coordinators, employees of a participating investigator or immediate family members
of the aforementioned are excluded from participating in this study
pregnant during the study.
2. Asthma: Subjects with a current diagnosis of asthma. (Subjects with a prior history
of asthma are eligible if they have a current diagnosis of COPD).
3. Other respiratory disorders: Subjects with 1-antitrypsin deficiency as the
underlying cause of COPD as the underlying cause of COPD, active tuberculosis,
lung cancer, bronchiectasis (Note: focal bronchiectasis is not exclusionary),
sarcoidosis, pulmonary fibrosis (Note: focal fibrotic pulmonary lesions are not
exclusionary), primary pulmonary hypertension, interstitial lung diseases, or other
active pulmonary diseases.
4. Lung resection: Subjects with lung volume reduction surgery within the 12 months
prior to Screening (Visit 1).
5. Chest X-ray (or CT scan): Subjects with a chest X-ray (or CT scan) that reveals
evidence of clinically significant abnormalities not believed to be due to the presence
of COPD. A chest X-ray must be taken at Screening (Visit 1) if a chest X-ray or CT
scan is not available within 1 year prior to Screening (Visit 1). For sites in
Germany: if a chest X-ray (or CT scan) within 1 year of Screening (Visit 1) is not
available, approval to conduct a diagnostic chest X-ray (CT scan) will need to be
obtained from the Federal Office for Radiation Protection (BfS).
6. Hospitalization: Subjects who are hospitalized due to poorly controlled COPD that
has not resolved at least 4 weeks prior to Screening (Visit 1) and at least 6 weeks
following the last dose of systemic corticosteroids.
7. Poorly controlled COPD: Subjects with poorly controlled COPD, defined as the
occurrence of any of the following in the 6 weeks prior to Screening (Visit 1):
Acute worsening of COPD that is managed by subject with systemic
corticosteroids or antibiotics or that requires treatment prescribed by a physician.
8. Lower respiratory tract infection: Subjects with lower respiratory tract infection
that required the use of antibiotics within 6 weeks prior to Screening (Visit 1).
9. COPD exacerbation/lower respiratory tract infection during Run-In Period:
Subjects who experience a moderate/severe COPD exacerbation (See definition in
“COPD Exacerbations and Pneumonia” Section 6.2.6) and/or a lower respiratory tract
infection (including pneumonia) during the Run-In Period.Note: Subjects who
experience a moderate/severe exacerbation and/or pneumonia during the Run-In
period must not be randomized at the randomization visit (Visit 2), but may be rescreened at a later time provided that the COPD exacerbation and/or pneumonia has
resolved prior to the re-screening visit. At the re-screening visit, chest x-ray should
confirm resolution of pneumonia. The re-screening visit must be conducted at least 6
weeks following the resolution date of the exacerbation and/or pneumonia and at least
6 weeks following the last dose of systemic corticosteroids (if applicable).
10. Abnormal clinically significant laboratory finding: Subjects who have an
abnormal clinical significant finding in any liver chemistry test at Screening (Visit 1)
or upon repeat prior to randomization.
11. Abnormal clinically significant 12-Lead ECG at Screening (Visit 1): Subjects who
have an abnormal, clinically significant ECG finding at Screening (Visit 1) or upon
repeat prior to randomization.
12. Other diseases/abnormalities: Subjects with historical or current evidence of
clinically significant and unstable disease such as cardiovascular (e.g., patients
requiring ICD, pacemaker requiring a rate set >60bpm, uncontrolled hypertension,
New Your Heart Association Class IV [New York Heart Association, 1994], known
left ventricular ejection fraction <30%) neurological, psychiatric, renal, hepatic,
immunological, endocrine (including uncontrolled diabetes or thyroid disease), peptic
ulcer disease, or hematological abnormalities. 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.
13. Liver Disease: Subjects who have unstable liver disease (as defined by the presence
of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric
varices or persistent jaundice), cirrhosis, known biliary abnormalities (with the
exception of Gilbert’s syndrome or asymptomatic gallstones)
14. Cancer: Subjects with carcinoma that has not been in complete remission for at least
5 years. Carcinoma in situ of the cervix, squamous cell carcinoma and basal cell
carcinoma of the skin would not be excluded if the subject has been considered cured
within 5 years since diagnosis.
15. Contraindications: Subjects with a history of allergy or hypersensitivity to any of
the study medications (e.g. beta-agonists, corticosteroids) or components of the
inhalation powder (e.g., lactose, magnesium stearate). In addition, subjects with a
history of severe milk protein allergy that, in the opinion of the investigator,
contraindicates the subject’s participation will also be excluded.
16. Drug/alcohol abuse: Subjects with a known or suspected history of alcohol or drug
abuse within the last 2 years
17. Medication prior to spirometry: Subjects who are medically unable to withhold
their albuterol (salbutamol) or their ipratropium bromide for the 4-hour period
required prior to spirometry testing at each study visit.
18. Additional medication: Use of the following medications within the following time
intervals prior to Screening (Visit 1) or during the study.
19. Oxygen therapy: Subjects receiving treatment with long-term oxygen therapy
(LTOT) or nocturnal oxygen therapy required for greater than 12 hours a day.
Oxygen prn use (i.e., 12 hours per day) is not exclusionary.
20. Sleep apnea: Subjects with clinically significant sleep apnea who require use of
continuous positive airway pressure (CPAP) device or non-invasive positive pressure
ventilation (NIPPV).
21. Pulmonary rehabilitation: Subjects who have participated in the acute phase of a
Pulmonary Rehabilitation Program within 4 weeks prior to Screening (Visit 1) or who
will enter the acute phase of a Pulmonary Rehabilitation Program during the study.
Subjects who are in the maintenance phase of a Pulmonary Rehabilitation Program
are not excluded.
22. Non-Compliance during Run-In Period: Failure to demonstrate adequate
compliance defined as completion of Diary Card (completed all diary entries on at
least 5 of the last 7 consecutive days), the ability to withhold anti-COPD medications
and to keep clinic visit appointments. In addition, subjects must have recorded the
Run-In study medication use on at least 5 of the last 7, consecutive days of the Run-In
period to continue in the study.
23. Potential of non-compliance: Subjects at risk of non-compliance, or unable to
comply with the study procedures. Any infirmity, disability, or geographic location
that would limit compliance for scheduled visits.
24. Questionable validity of consent: Subjects with a history of psychiatric disease,
intellectual deficiency, poor motivation or other conditions that will limit the validity
of informed consent to participate in the study.
25. Prior use of study medication/other investigational drugs: Subjects who have
received an investigational drug within 30 days of entry into this study (Screening), or
within 5 drug half-lives of the investigational drug, whichever is longer.
26. Affiliation with investigator site: Study investigators, sub-investigators, study
coordinators, employees of a participating investigator or immediate family members
of the aforementioned are excluded from participating in this study
The Estimated Number of Participants
-
Taiwan
42 participants
-
Global
1582 participants
