A 1-year Multi-center, Prospective, Cohort Study in Patie... | NCT01794780 | Trialant
NCT01794780
Sponsor
Novartis Pharmaceuticals
Status
Completed
Last Update Posted
Sep 26, 2019Actual
Enrollment
2,229Actual
Phase
Phase 4
Conditions
COPD
Interventions
LABA based treatment: indacaterol
LAMA based treatment: tiotropium
LABA/ICS based treatment: salmeterol/fluticasone
LABA/ICS based treatment: budesonide/formoterol
theophylline based treatment
Other treatment
Countries
China
Protocol Section
Identification Module
NCT ID
NCT01794780
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
CQAB149BCN01
Secondary IDs
Not provided
Brief Title
A 1-year Multi-center, Prospective, Cohort Study in Patients With Chronic Obstructive Pulmonary Disease Treated With Long-acting Bronchodilator
Official Title
A 1-year Multi-center, Prospective, Cohort Study in Patients With Chronic Obstructive Pulmonary Disease Treated With Long-acting Bronchodilator
Acronym
Not provided
Organization
NovartisINDUSTRY
Status Module
Record Verification Date
Aug 2019
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Feb 5, 2013Actual
Primary Completion Date
May 25, 2015Actual
Completion Date
May 25, 2015Actual
First Submitted Date
Feb 15, 2013
First Submission Date that Met QC Criteria
Feb 15, 2013
First Posted Date
Feb 20, 2013Estimated
Results Waived
Not provided
Results First Submitted Date
Jun 1, 2017
Results First Submitted that Met QC Criteria
Aug 27, 2019
Results First Posted Date
Sep 26, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Aug 27, 2019
Last Update Posted Date
Sep 26, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Novartis PharmaceuticalsINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Not provided
Is FDA Regulated Drug
No
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
This multi-center study is designed to describe natural history of disease, treatment and health care products in physician-diagnosed COPD patients who require adding daily maintenance therapy in real world.
The study planned to enroll 550 patients in Indacaterol group and 9450 patients in non- Indacaterol group, a total of 10,000 patients. Enrollment was stopped at 2253 patients due to low recruitment in indacaterol group. Finally a total of 2229 patients were analyzed in full analysis set.
A total of 2253 patients entered into the database, of which 24 patients were exclude during the data review meetings, because they did not met the inclusion/exclusion criteria. Hence a total of 2229 patients enrolled successfully.
Detailed Description
Not provided
Conditions Module
Conditions
COPD
Keywords
COPD
Chronic obstructive pulmonary disease (COPD),
Chronic obstructive lung disease (COLD),
Chronic obstructive airway disease (COAD),
Cronchitis,
Emphysema
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 4
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
2,229Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Indacaterol
Experimental
LABA: Indacaterol, once a day, 150μg each time
Drug: LABA based treatment: indacaterol
Tiotropium Bromide
Experimental
LAMA: Tiotropium Bromide, once a day, 18 μg
Drug: LAMA based treatment: tiotropium
Salmeterol/Fluticasone
Experimental
LABA/ICS: Salmeterol/Fluticasone, twice a day, 50/250 μg, 50/500 μg
Drug: LABA/ICS based treatment: salmeterol/fluticasone
Budesonide/ formoterol
Experimental
Budesonide/formoterol, twice daily, two suction each time, 160/4.5 μg
Drug: LABA/ICS based treatment: budesonide/formoterol
Indacaterol +Tiotropium
Experimental
Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg
Drug: LABA based treatment: indacaterol
Drug: LAMA based treatment: tiotropium
LABA/ICS (Or budesonide/ formoterol)+ Tiotropium
Interventions
Name
Type
Description
Arm Group Labels
Other Names
LABA based treatment: indacaterol
Drug
LABA based treatment: indacaterol
Indacaterol
Indacaterol +Tiotropium
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. A positive change from baseline in FEV1 indicates improvement in lung function. Pulmonary function tests were performed at study visits including FEV1, and Force Vital Capacity (FVC). These were performed 30 minutes before treatment and not more than 2 hours in advance after stopping the Long-acting bronchodilators eight hours before visits. In order to reduce the variation between each test, the same instrument was used in the whole research process if condition allowed.
Baseline,3 months
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. A positive change from baseline in FEV1 indicates improvement in lung function. Pulmonary function tests were performed at study visits including FEV1, and Force Vital Capacity (FVC). These were performed 30 minutes before treatment and not more than 2 hours in advance after stopping the long-acting bronchodilators eight hours before visits. In order to reduce the variation between each test, the same instrument was used in the whole research process if condition allowed.
Han J, Dai L, Zhong N, Young D. Breathlessness or health status in chronic obstructive pulmonary disease: the impact of different definitions. COPD. 2015 Apr;12(2):115-25. doi: 10.3109/15412555.2014.974741. Epub 2014 Dec 4.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
Not provided
Recruitment Details
A total of 2253 patients entered into the database, of which 24 patients were exclude during the data review meetings, because they did not met the inclusion/exclusion criteria. Hence a total of 2229 patients enrolled successfully.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Indacaterol
LABA: Indacaterol, once a day, 150μg each time
FG001
Tiotropium Bromide
LAMA: Tiotropium Bromide, once a day, 18 μg
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Not provided
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Non-Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
None (Open Label)
Masking Description
Not provided
Who Masked
Not provided
Experimental
Salmeterol / fluticasone Or budesonide / formoterol
Drug: LAMA based treatment: tiotropium
Drug: LABA/ICS based treatment: salmeterol/fluticasone
Drug: LABA/ICS based treatment: budesonide/formoterol
Oral theophylline
Experimental
Drug: theophylline based treatment
Other treatment
Experimental
non-long-acting bronchodilators for COPD treatment, such treatments were classified as "other treatments"
Drug: Other treatment
LAMA based treatment: tiotropium
Drug
LAMA based treatment: tiotropium
Indacaterol +Tiotropium
LABA/ICS (Or budesonide/ formoterol)+ Tiotropium
Tiotropium Bromide
LABA/ICS based treatment: salmeterol/fluticasone
Drug
LABA/ICS based treatment: salmeterol/fluticasone
LABA/ICS (Or budesonide/ formoterol)+ Tiotropium
Salmeterol/Fluticasone
LABA/ICS based treatment: budesonide/formoterol
Drug
LABA/ICS based treatment: budesonide/formoterol
Budesonide/ formoterol
LABA/ICS (Or budesonide/ formoterol)+ Tiotropium
theophylline based treatment
Drug
theophylline based treatment
Oral theophylline
Other treatment
Drug
non-long-acting bronchodilators for COPD treatment, such treatments were classified as "other treatments"
Other treatment
Baseline,12 months
COPD Exacerbation
Number of COPD exacerbations evaluated over 12 months. COPD exacerbation is defined as a new onset or worsening of at least 1 respiratory major symptoms (e.g. dyspnea, cough, sputum volume or sputum purulence) for at least 3 consecutive days, which results in recorded treatment change (antibiotics/steroids/oxygen therapy) OR recorded COPD related hospitalization/Emergency visit. COPD exacerbation is not considered as adverse event, and should only be recorded in COPD e-CRF.
Baseline,12 months
Change in Health Status Questionnaire MMRC
The mMRC scale is scored from 0 (less severe) to 4 (severe). 0 Not troubled with breathlessness except with strenuous exercise; 1 Troubled by shortness of breath when hurrying on the level or walking up a slight hill; 2 Walks slower than people of the same age on the level because of breathlessness or has to stop for breath when walking at own pace on the level; 3 Stops for breath after walking about 100 yards or after a few minutes on the level; 4 Too breathless to leave the house or breathless when dressing or undressing. The modified Medical Research Council (mMRC) Dyspnea Scale , is a five-item instrument (part of the Borg scale) to assess a patient's degree of breathlessness in relation to physical activity. Participants will be required to read a brief description of an activity and then select a statement that best describes their experience with dyspnea at Visit 101. The mMRC was assessed by the investigators at the scheduled visits.
Baseline,3,6,9,12 months
Change From Baseline in Questionnaire COPD Assessment Test (CAT) Score
The COPD assessment test (CAT) is a short instrument scale used to quantify the symptom burden of COPD and will be used to assess the health status of patients in this study. It consists of eight items, each presented as a semantic 6-point differential scale, providing a total score out of 40. A higher score indicates a worse health status. Scores of 0 - 10, 11 - 20, 21 - 30 and 31 - 40 represent a mild, moderate, severe or very severe clinical impact of COPD upon the patient.
Baseline,3,6,9,12 months
Change From Baseline Questionnaire Transition Dyspnea Index (TDI) Score
Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline. BDI/TDI was used to assess dyspnea from several aspects, caused by daily activities. These were evaluated by the investigators in the study at the scheduled study visits. The indices were to be evaluated by the same investigator.as far as possible.
Baseline,3,6,9,12 months
Zhengzhou
China
FG002
Salmeterol/Fluticasone
LABA/ICS: Salmeterol/Fluticasone, twice a day, 50/250 μg, 50/500 μg
FG003
Budesonide/ Formoterol
Budesonide/formoterol, twice daily, two suction each time, 160/4.5 μg
FG004
Indacaterol +Tiotropium
Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg
FG005
LABA/ICS (Or Budesonide/ Formoterol)+ Tiotropium
Salmeterol / fluticasone Or budesonide / formoterol
FG006
Oral Theophylline
Oral theophylline
FG007
Other Treatment
FG00032 subjects
FG001276 subjects
FG002813 subjects
FG003283 subjects
FG0049 subjects
FG005632 subjects
FG006154 subjects
FG00730 subjects
COMPLETED
FG00015 subjects
FG001180 subjects
FG002571 subjects
FG003200 subjects
FG0046 subjects
FG005452 subjects
FG006112 subjects
FG00721 subjects
NOT COMPLETED
FG00017 subjects
FG00196 subjects
FG002242 subjects
FG00383 subjects
FG0043 subjects
FG005180 subjects
FG00642 subjects
FG0079 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
Death
FG0000 subjects
FG0012 subjects
FG00214 subjects
FG0031 subjects
FG004
Lost to Follow-up
FG00010 subjects
FG00164 subjects
FG002165 subjects
FG00353 subjects
FG004
Withdrew informed consent
FG0007 subjects
FG00117 subjects
FG00236 subjects
FG0039 subjects
FG004
Other
FG0000 subjects
FG00112 subjects
FG00225 subjects
FG00320 subjects
FG004
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Indacaterol
LABA: Indacaterol, once a day, 150μg each time
BG001
Tiotropium Bromide
LAMA: Tiotropium Bromide, once a day, 18 μg
BG002
Salmeterol/Fluticasone
LABA/ICS: Salmeterol/Fluticasone, twice a day, 50/250 μg, 50/500 μg
BG003
Budesonide/ Formoterol
Budesonide/formoterol, twice daily, two suction each time, 160/4.5 μg
BG004
Indacaterol +Tiotropium
Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg
BG005
LABA/ICS (Or Budesonide/ Formoterol)+ Tiotropium
Salmeterol / fluticasone Or budesonide / formoterol
BG006
Oral Theophylline
Oral theophylline
BG007
Other Treatment
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00032
BG001276
BG002813
BG003283
BG0049
BG005632
BG006154
BG00730
BG0082229
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00066.12± 9.238
BG00168.93± 9.145
BG00267.00± 9.353
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG0001
BG00152
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. A positive change from baseline in FEV1 indicates improvement in lung function. Pulmonary function tests were performed at study visits including FEV1, and Force Vital Capacity (FVC). These were performed 30 minutes before treatment and not more than 2 hours in advance after stopping the Long-acting bronchodilators eight hours before visits. In order to reduce the variation between each test, the same instrument was used in the whole research process if condition allowed.
FAS: Two Arms/Groups were grouped together in the analysis as some of the analysis required to combine the results. Per protocol it was not the intent to compare the results between different standard of care (LABA/ICS). Efficacy data were not collected separately for the "Salmeterol / fluticasone" and "budesonide / formoterol" Arms/Groups,"
Posted
Mean
Standard Deviation
Liters
Baseline,3 months
ID
Title
Description
OG000
Indacaterol
LABA: Indacaterol, once a day, 150μg each time
OG001
Tiotropium
LAMA: Tiotropium Bromide, once a day, 18 μg
OG002
LABA/ICS
Salmeterol / fluticasone Or budesonide / formoterol
OG003
Indacaterol + Tiotropium
Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg
OG004
LABA/ICS + Tiotropium
(Salmeterol / fluticasone Or budesonide / formoterol) + tiotropium
OG005
Oral Theophylline
Oral theophylline
Units
Counts
Participants
OG00022
OG001154
OG002702
OG003
Title
Denominators
Categories
Title
Measurements
OG000-0.042± 0.1742
OG0010.006± 0.2537
OG0020.033± 0.3790
OG003
Secondary
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Forced expiratory volume in 1 second (FEV1) is the amount of air that can be exhaled in one second. A positive change from baseline in FEV1 indicates improvement in lung function. Pulmonary function tests were performed at study visits including FEV1, and Force Vital Capacity (FVC). These were performed 30 minutes before treatment and not more than 2 hours in advance after stopping the long-acting bronchodilators eight hours before visits. In order to reduce the variation between each test, the same instrument was used in the whole research process if condition allowed.
FAS: Two Arms/Groups were grouped together in the analysis as some of the analysis required to combine the results. Per protocol it was not the intent to compare the results between different standard of care (LABA/ICS). Efficacy data were not collected separately for the "Salmeterol / fluticasone" and "budesonide / formoterol" Arms/Groups,"
Posted
Mean
Standard Deviation
Liters
Baseline,12 months
ID
Title
Description
OG000
Indacaterol
LABA: Indacaterol, once a day, 150μg each time
OG001
Tiotropium Bromide
LAMA: Tiotropium Bromide, once a day, 18 μg
OG002
LABA/ICS
Secondary
COPD Exacerbation
Number of COPD exacerbations evaluated over 12 months. COPD exacerbation is defined as a new onset or worsening of at least 1 respiratory major symptoms (e.g. dyspnea, cough, sputum volume or sputum purulence) for at least 3 consecutive days, which results in recorded treatment change (antibiotics/steroids/oxygen therapy) OR recorded COPD related hospitalization/Emergency visit. COPD exacerbation is not considered as adverse event, and should only be recorded in COPD e-CRF.
FAS: Two Arms/Groups were grouped together in the analysis as some of the analysis required to combine the results. Per protocol it was not the intent to compare the results between different standard of care (LABA/ICS)
Posted
Mean
Standard Deviation
COPD Exacerbations/year
Baseline,12 months
ID
Title
Description
OG000
Indacaterol
LABA: Indacaterol, once a day, 150μg each time
OG001
Tiotropium Bromide
LAMA: Tiotropium Bromide, once a day, 18 μg
OG002
Salmeterol/Fluticasone
LABA/ICS: Salmeterol/Fluticasone, twice a day, 50/250 μg, 50/500 μg
OG003
Secondary
Change in Health Status Questionnaire MMRC
The mMRC scale is scored from 0 (less severe) to 4 (severe). 0 Not troubled with breathlessness except with strenuous exercise; 1 Troubled by shortness of breath when hurrying on the level or walking up a slight hill; 2 Walks slower than people of the same age on the level because of breathlessness or has to stop for breath when walking at own pace on the level; 3 Stops for breath after walking about 100 yards or after a few minutes on the level; 4 Too breathless to leave the house or breathless when dressing or undressing. The modified Medical Research Council (mMRC) Dyspnea Scale , is a five-item instrument (part of the Borg scale) to assess a patient's degree of breathlessness in relation to physical activity. Participants will be required to read a brief description of an activity and then select a statement that best describes their experience with dyspnea at Visit 101. The mMRC was assessed by the investigators at the scheduled visits.
FAS: Two Arms/Groups were grouped together in the analysis as some of the analysis required to combine the results. Per protocol it was not the intent to compare the results between different standard of care (LABA/ICS).Efficacy data were not collected separately for the "Salmeterol / fluticasone" and "budesonide / formoterol" Arms/Groups,"
Posted
Number
Number of participants
Baseline,3,6,9,12 months
ID
Title
Description
OG000
Indacaterol
LABA: Indacaterol, once a day, 150μg each time
OG001
Tiotropium Bromide
Secondary
Change From Baseline in Questionnaire COPD Assessment Test (CAT) Score
The COPD assessment test (CAT) is a short instrument scale used to quantify the symptom burden of COPD and will be used to assess the health status of patients in this study. It consists of eight items, each presented as a semantic 6-point differential scale, providing a total score out of 40. A higher score indicates a worse health status. Scores of 0 - 10, 11 - 20, 21 - 30 and 31 - 40 represent a mild, moderate, severe or very severe clinical impact of COPD upon the patient.
FAS: Two Arms/Groups were grouped together in the analysis as some of the analysis required to combine the results. Per protocol it was not the intent to compare the results between different standard of care (LABA/ICS). Efficacy data were not collected separately for the "Salmeterol / fluticasone" and "budesonide / formoterol" Arms/Groups,"
Posted
Mean
Standard Deviation
Score on a scale
Baseline,3,6,9,12 months
ID
Title
Description
OG000
Indacaterol
LABA: Indacaterol, once a day, 150μg each time
OG001
Tiotropium Bromide
LAMA: Tiotropium Bromide, once a day, 18 μg
OG002
LABA/ICS
Salmeterol / fluticasone Or budesonide / formoterol
Secondary
Change From Baseline Questionnaire Transition Dyspnea Index (TDI) Score
Transition Dyspnea Index (TDI) captures changes from baseline. The TDI score is based on three domains with each domain scored from -3 (major deterioration) to +3 (major improvement), to give an overall score of -9 to +9, a negative score indicating a deterioration from baseline. A TDI focal score of 1 is considered to be a clinically significant improvement from baseline. BDI/TDI was used to assess dyspnea from several aspects, caused by daily activities. These were evaluated by the investigators in the study at the scheduled study visits. The indices were to be evaluated by the same investigator.as far as possible.
FAS: Two Arms/Groups were grouped together in the analysis as some of the analysis required to combine the results. Per protocol it was not the intent to compare the results between different standard of care (LABA/ICS). Efficacy data were not collected separately for the "Salmeterol / fluticasone" and "budesonide / formoterol" Arms/Groups,"
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0021 affected813 at risk
EG0030 affected283 at risk
EG004
Malignant lung neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0021 affected813 at risk
EG003
Neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0021 affected813 at risk
EG003
Rectal cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0020 affected813 at risk
EG003
Acute coronary syndrome
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0021 affected813 at risk
EG003
Acute left ventricular failure
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0020 affected813 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0022 affected813 at risk
EG003
Atrioventricular block
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0021 affected813 at risk
EG003
Cardiac disorder
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0020 affected813 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0020 affected813 at risk
EG003
Hypertensive heart disease
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0021 affected813 at risk
EG003
Palpitations
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0020 affected813 at risk
EG003
Unstable angina
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0021 affected813 at risk
EG003
Ventricular arrhythmia
Cardiac disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0021 affected813 at risk
EG003
Positional vertigo
Ear and labyrinth disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0021 affected813 at risk
EG003
Goitre
Endocrine disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0020 affected813 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0020 affected813 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0001 affected32 at risk
EG0010 affected276 at risk
EG0020 affected813 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0020 affected813 at risk
EG003
Upper gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected276 at risk
EG0020 affected813 at risk
EG003
Death
General disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected276 at risk
EG0022 affected813 at risk
EG003
Multi-organ failure
General disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0021 affected813 at risk
EG003
Sudden cardiac death
General disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0020 affected813 at risk
EG003
Sudden death
General disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0020 affected813 at risk
EG003
Abdominal infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0021 affected813 at risk
EG003
Appendicitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected276 at risk
EG0020 affected813 at risk
EG003
Bronchitis
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected276 at risk
EG0023 affected813 at risk
EG003
Herpes zoster
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected276 at risk
EG0020 affected813 at risk
EG003
Infectious pneumonia
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0012 affected276 at risk
EG0020 affected813 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0021 affected813 at risk
EG003
Lung infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0021 affected813 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0020 affected813 at risk
EG003
Hip fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected276 at risk
EG0020 affected813 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected276 at risk
EG0020 affected813 at risk
EG003
Rheumatoid arthritis
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0020 affected813 at risk
EG003
Spondyloarthropathy
Musculoskeletal and connective tissue disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0011 affected276 at risk
EG0020 affected813 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0020 affected813 at risk
EG003
Post herpetic neuralgia
Nervous system disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0021 affected813 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0021 affected813 at risk
EG003
Bronchiectasis
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0021 affected813 at risk
EG003
Respiratory failure
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0022 affected813 at risk
EG003
Spontaneous pneumothorax
Respiratory, thoracic and mediastinal disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0020 affected813 at risk
EG003
Hypertension
Vascular disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0020 affected813 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Upper respiratory tract infection
Infections and infestations
MedDRA
Systematic Assessment
EG0002 affected32 at risk
EG0011 affected276 at risk
EG00214 affected813 at risk
EG0031 affected283 at risk
EG0040 affected9 at risk
EG0054 affected632 at risk
EG0061 affected154 at risk
EG0071 affected30 at risk
Pruritus
Skin and subcutaneous tissue disorders
MedDRA
Systematic Assessment
EG0000 affected32 at risk
EG0010 affected276 at risk
EG0020 affected813 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial or disclosure of trial results in their entirety.
Point of Contact
Title
Organization
Phone
Extension
Email
Study Director
Novartis Pharmaceutical
862-778-8300
ID
Term
D029424
Pulmonary Disease, Chronic Obstructive
D004646
Emphysema
Ancestor Terms
ID
Term
D008173
Lung Diseases, Obstructive
D008171
Lung Diseases
D012140
Respiratory Tract Diseases
D002908
Chronic Disease
D020969
Disease Attributes
D010335
Pathologic Processes
D013568
Pathological Conditions, Signs and Symptoms
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
D000068298
Fluticasone
D000068759
Formoterol Fumarate
Ancestor Terms
ID
Term
D000730
Androstadienes
D000736
Androstenes
D000731
Androstanes
D013256
Steroids
D000072473
Fused-Ring Compounds
D011083
Polycyclic Compounds
D004983
Ethanolamines
D000605
Amino Alcohols
D000438
Alcohols
D009930
Organic Chemicals
D000588
Amines
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0059 subjects
FG0064 subjects
FG0070 subjects
2 subjects
FG00599 subjects
FG00630 subjects
FG0075 subjects
0 subjects
FG00548 subjects
FG0064 subjects
FG0073 subjects
1 subjects
FG00524 subjects
FG0064 subjects
FG0071 subjects
67.02
± 9.858
BG00469.49± 8.873
BG00567.74± 9.427
BG00667.86± 9.652
BG00766.14± 10.205
BG00867.50± 9.453
154
BG00349
BG0041
BG00581
BG00635
BG0075
BG008378
Male
BG00031
BG001224
BG002659
BG003234
BG0048
BG005551
BG006119
BG00725
BG0081851
6
OG004404
OG005104
0.022
± 0.1157
OG0040.011± 0.2417
OG0050.012± 0.3405
Salmeterol / fluticasone Or budesonide / formoterol
OG003
Indacaterol +Tiotropium
Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg
OG004
LABA/ICS + Tiotropium
(Salmeterol / fluticasone Or budesonide / formoterol) + tiotropium
OG005
Oral Theophylline
Oral theophylline
Units
Counts
Participants
OG00010
OG001129
OG002597
OG0033
OG004317
OG00587
Title
Denominators
Categories
Title
Measurements
OG0000.056± 0.2137
OG001-0.036± 0.2395
OG0020.056± 0.4335
OG0030.030± 0.0854
OG004-0.028± 0.2258
OG0050.046± 0.3654
Budesonide/ Formoterol
Budesonide/formoterol, twice daily, two suction each time, 160/4.5 μg
OG004
LABA/ICS
Salmeterol / fluticasone Or budesonide / formoterol
OG005
Indacaterol +Tiotropium
Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg
OG006
LABA/ICS + Tiotropium
(Salmeterol / fluticasone Or budesonide / formoterol) + tiotropium
OG007
Oral Theophylline
Oral theophylline
Units
Counts
Participants
OG00032
OG001276
OG002813
OG003283
OG0041096
OG0059
OG006632
OG007154
Title
Denominators
Categories
Title
Measurements
OG0001.1± 3.53
OG0010.5± 1.89
OG0021.1± 7.74
OG0030.4± 1.89
OG0040.9± 6.72
OG0054.1± 5.46
OG0060.8± 3.47
OG0071.0± 3.57
LAMA: Tiotropium Bromide, once a day, 18 μg
OG002
LABA/ICS
Salmeterol / fluticasone Or budesonide / formoterol
OG003
Indacaterol +Tiotropium
Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg
OG004
LABA/ICS + Tiotropium
(Salmeterol / fluticasone Or budesonide / formoterol) + tiotropium
OG005
Oral Theophylline
Oral theophylline
Units
Counts
Participants
OG00032
OG001276
OG0021096
OG0039
OG004632
OG005154
Title
Denominators
Categories
Baseline scale item 0
ParticipantsOG00032
ParticipantsOG001276
ParticipantsOG0021096
ParticipantsOG0039
ParticipantsOG004632
ParticipantsOG005154
Title
Measurements
OG0004
OG00140
OG002161
OG003
Baseline scale item 1
ParticipantsOG00032
ParticipantsOG001276
ParticipantsOG0021096
ParticipantsOG0039
Baseline scale item 2
ParticipantsOG00032
ParticipantsOG001276
ParticipantsOG0021096
ParticipantsOG0039
Baseline scale item 3
ParticipantsOG00032
ParticipantsOG001276
ParticipantsOG0021096
ParticipantsOG0039
Baseline scale item 4
ParticipantsOG00032
ParticipantsOG001276
ParticipantsOG0021096
ParticipantsOG0039
3 month Scale item 0
ParticipantsOG00020
ParticipantsOG001167
ParticipantsOG002741
ParticipantsOG0037
3 month Scale item 1
ParticipantsOG00020
ParticipantsOG001167
ParticipantsOG002741
ParticipantsOG0037
3 month Scale item 2
ParticipantsOG00020
ParticipantsOG001167
ParticipantsOG002741
ParticipantsOG0037
3 month Scale item 3
ParticipantsOG00020
ParticipantsOG001167
ParticipantsOG002741
ParticipantsOG0037
3 month Scale item 4
ParticipantsOG00020
ParticipantsOG001167
ParticipantsOG002741
ParticipantsOG0037
6 month Scale item 0
ParticipantsOG00016
ParticipantsOG001141
ParticipantsOG002583
ParticipantsOG0036
6 month Scale item 1
ParticipantsOG00016
ParticipantsOG001141
ParticipantsOG002583
ParticipantsOG0036
6 month Scale item 2
ParticipantsOG00016
ParticipantsOG001141
ParticipantsOG002583
ParticipantsOG0036
6 month Scale item 3
ParticipantsOG00016
ParticipantsOG001141
ParticipantsOG002583
ParticipantsOG0036
6 month Scale item 4
ParticipantsOG00016
ParticipantsOG001141
ParticipantsOG002583
ParticipantsOG0036
9 month Scale item 0
ParticipantsOG00013
ParticipantsOG001121
ParticipantsOG002549
ParticipantsOG0033
9 month Scale item 1
ParticipantsOG00013
ParticipantsOG001121
ParticipantsOG002549
ParticipantsOG0033
9 month Scale item 2
ParticipantsOG00013
ParticipantsOG001121
ParticipantsOG002549
ParticipantsOG0033
9 month Scale item 3
ParticipantsOG00013
ParticipantsOG001121
ParticipantsOG002549
ParticipantsOG0033
9 month Scale item 4
ParticipantsOG00013
ParticipantsOG001121
ParticipantsOG002549
ParticipantsOG0033
12 month Scale item 0
ParticipantsOG00010
ParticipantsOG001131
ParticipantsOG002602
ParticipantsOG0033
12 month Scale item 1
ParticipantsOG00010
ParticipantsOG001131
ParticipantsOG002602
ParticipantsOG0033
12 month Scale item 2
ParticipantsOG00010
ParticipantsOG001131
ParticipantsOG002602
ParticipantsOG0033
12 month Scale item 3
ParticipantsOG00010
ParticipantsOG001131
ParticipantsOG002602
ParticipantsOG0033
12 month Scale item 4
ParticipantsOG00010
ParticipantsOG001131
ParticipantsOG002602
ParticipantsOG0033
OG003
Indacaterol +Tiotropium
Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg
OG004
LABA/ICS + Tiotropium
(Salmeterol / fluticasone Or budesonide / formoterol) + tiotropium
OG005
Oral Theophylline
Oral theophylline
Units
Counts
Participants
OG00032
OG001276
OG0021096
OG0039
OG004632
OG005154
Title
Denominators
Categories
3 Month
ParticipantsOG00020
ParticipantsOG001167
ParticipantsOG002741
ParticipantsOG0037
ParticipantsOG004411
ParticipantsOG005110
Title
Measurements
OG000-1.9± 5.12
OG001-2.1± 5.58
OG002-2.3± 5.68
OG003
6 Month
ParticipantsOG00016
ParticipantsOG001140
ParticipantsOG002582
ParticipantsOG0036
9 Month
ParticipantsOG00013
ParticipantsOG001121
ParticipantsOG002549
ParticipantsOG0033
12 Month
ParticipantsOG00010
ParticipantsOG001131
ParticipantsOG002603
ParticipantsOG0033
Salmeterol / fluticasone Or budesonide / formoterol
OG003
Indacaterol +Tiotropium
Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg
OG004
LABA/ICS + Tiotropium
Salmeterol / fluticasone Or budesonide / formoterol) + tiotropium