A 1-year Multi-center, Prospective, Cohort Study in Patients With Chronic Obstructive Pulmonary Disease Treated With Long-acting Bronchodilator
Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT01794780
Collaborator
(none)
2,229
2
8
27.6
1114.5
40.4
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
2229 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A 1-year Multi-center, Prospective, Cohort Study in Patients With Chronic Obstructive Pulmonary Disease Treated With Long-acting Bronchodilator
Actual Study Start Date
:
Feb 5, 2013
Actual Primary Completion Date
:
May 25, 2015
Actual Study Completion Date
:
May 25, 2015
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Indacaterol LABA: Indacaterol, once a day, 150μg each time |
Drug: LABA based treatment: indacaterol
LABA based treatment: indacaterol
|
| Experimental: Tiotropium Bromide LAMA: Tiotropium Bromide, once a day, 18 μg |
Drug: LAMA based treatment: tiotropium
LAMA based treatment: tiotropium
|
| Experimental: Salmeterol/Fluticasone LABA/ICS: Salmeterol/Fluticasone, twice a day, 50/250 μg, 50/500 μg |
Drug: LABA/ICS based treatment: salmeterol/fluticasone
LABA/ICS based treatment: salmeterol/fluticasone
|
| Experimental: Budesonide/ formoterol Budesonide/formoterol, twice daily, two suction each time, 160/4.5 μg |
Drug: LABA/ICS based treatment: budesonide/formoterol
LABA/ICS based treatment: budesonide/formoterol
|
| Experimental: Indacaterol +Tiotropium Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg |
Drug: LABA based treatment: indacaterol
LABA based treatment: indacaterol
Drug: LAMA based treatment: tiotropium
LAMA based treatment: tiotropium
|
| Experimental: LABA/ICS (Or budesonide/ formoterol)+ Tiotropium Salmeterol / fluticasone Or budesonide / formoterol |
Drug: LAMA based treatment: tiotropium
LAMA based treatment: tiotropium
Drug: LABA/ICS based treatment: salmeterol/fluticasone
LABA/ICS based treatment: salmeterol/fluticasone
Drug: LABA/ICS based treatment: budesonide/formoterol
LABA/ICS based treatment: budesonide/formoterol
|
| Experimental: Oral theophylline
|
Drug: theophylline based treatment
theophylline based treatment
|
| Experimental: Other treatment non-long-acting bronchodilators for COPD treatment, such treatments were classified as "other treatments" |
Drug: Other treatment
non-long-acting bronchodilators for COPD treatment, such treatments were classified as "other treatments"
|
Outcome Measures
Primary Outcome Measures
- Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) [Baseline,3 months]
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.
Secondary Outcome Measures
- Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) [Baseline,12 months]
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.
- COPD Exacerbation [Baseline,12 months]
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.
- Change in Health Status Questionnaire MMRC [Baseline,3,6,9,12 months]
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.
- Change From Baseline in Questionnaire COPD Assessment Test (CAT) Score [Baseline,3,6,9,12 months]
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.
- Change From Baseline Questionnaire Transition Dyspnea Index (TDI) Score [Baseline,3,6,9,12 months]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Willing and able to provide informed consent
-
Physician-diagnosis of COPD
-
COPD patients requiring long-acting bronchodilator treatment
-
Patients with spirometry available at baseline
Exclusion Criteria:
-
Patients who have a diagnosis of asthma.
-
Patients who had been hospitalized for a COPD exacerbation in the 4 weeks prior to Visit 1.
-
Current clinical diagnosis of other chronic respiratory illnesses
-
Concurrent participation in a clinical trial or use of an investigational drug.
-
Active malignancy or history of malignancy of any organ system
-
Pregnant or nursing (lactating) women
-
Women of child-bearing potential with no contraception Other protocol-defined inclusion/exclusion criteria may apply.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Novartis Investigative Site | Beijing | China | 100730 | |
| 2 | Novartis Investigative Site | Zhengzhou | China |
Sponsors and Collaborators
- Novartis Pharmaceuticals
Investigators
- Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01794780
Other Study ID Numbers:
- CQAB149BCN01
First Posted:
Feb 20, 2013
Last Update Posted:
Sep 26, 2019
Last Verified:
Aug 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Novartis Pharmaceuticals
Additional relevant MeSH terms:
Study Results
Participant Flow
| 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. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Indacaterol | Tiotropium Bromide | Salmeterol/Fluticasone | Budesonide/ Formoterol | Indacaterol +Tiotropium | LABA/ICS (Or Budesonide/ Formoterol)+ Tiotropium | Oral Theophylline | Other Treatment |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | LABA: Indacaterol, once a day, 150μg each time | LAMA: Tiotropium Bromide, once a day, 18 μg | LABA/ICS: Salmeterol/Fluticasone, twice a day, 50/250 μg, 50/500 μg | Budesonide/formoterol, twice daily, two suction each time, 160/4.5 μg | Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg | Salmeterol / fluticasone Or budesonide / formoterol | Oral theophylline | |
| Period Title: Overall Study | ||||||||
| STARTED | 32 | 276 | 813 | 283 | 9 | 632 | 154 | 30 |
| COMPLETED | 15 | 180 | 571 | 200 | 6 | 452 | 112 | 21 |
| NOT COMPLETED | 17 | 96 | 242 | 83 | 3 | 180 | 42 | 9 |
Baseline Characteristics
| Arm/Group Title | Indacaterol | Tiotropium Bromide | Salmeterol/Fluticasone | Budesonide/ Formoterol | Indacaterol +Tiotropium | LABA/ICS (Or Budesonide/ Formoterol)+ Tiotropium | Oral Theophylline | Other Treatment | Total |
|---|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | LABA: Indacaterol, once a day, 150μg each time | LAMA: Tiotropium Bromide, once a day, 18 μg | LABA/ICS: Salmeterol/Fluticasone, twice a day, 50/250 μg, 50/500 μg | Budesonide/formoterol, twice daily, two suction each time, 160/4.5 μg | Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg | Salmeterol / fluticasone Or budesonide / formoterol | Oral theophylline | Total of all reporting groups | |
| Overall Participants | 32 | 276 | 813 | 283 | 9 | 632 | 154 | 30 | 2229 |
| Age (Years) [Mean (Standard Deviation) ] | |||||||||
| Mean (Standard Deviation) [Years] |
66.12
(9.238)
|
68.93
(9.145)
|
67.00
(9.353)
|
67.02
(9.858)
|
69.49
(8.873)
|
67.74
(9.427)
|
67.86
(9.652)
|
66.14
(10.205)
|
67.50
(9.453)
|
| Sex: Female, Male (Count of Participants) | |||||||||
| Female |
1
3.1%
|
52
18.8%
|
154
18.9%
|
49
17.3%
|
1
11.1%
|
81
12.8%
|
35
22.7%
|
5
16.7%
|
378
17%
|
| Male |
31
96.9%
|
224
81.2%
|
659
81.1%
|
234
82.7%
|
8
88.9%
|
551
87.2%
|
119
77.3%
|
25
83.3%
|
1851
83%
|
Outcome Measures
| Title | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) |
|---|---|
| Description | 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. |
| Time Frame | Baseline,3 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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," |
| Arm/Group Title | Indacaterol | Tiotropium | LABA/ICS | Indacaterol + Tiotropium | LABA/ICS + Tiotropium | Oral Theophylline |
|---|---|---|---|---|---|---|
| Arm/Group Description | LABA: Indacaterol, once a day, 150μg each time | LAMA: Tiotropium Bromide, once a day, 18 μg | Salmeterol / fluticasone Or budesonide / formoterol | Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg | (Salmeterol / fluticasone Or budesonide / formoterol) + tiotropium | Oral theophylline |
| Measure Participants | 22 | 154 | 702 | 6 | 404 | 104 |
| Mean (Standard Deviation) [Liters] |
-0.042
(0.1742)
|
0.006
(0.2537)
|
0.033
(0.3790)
|
0.022
(0.1157)
|
0.011
(0.2417)
|
0.012
(0.3405)
|
| Title | Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) |
|---|---|
| Description | 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. |
| Time Frame | Baseline,12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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," |
| Arm/Group Title | Indacaterol | Tiotropium Bromide | LABA/ICS | Indacaterol +Tiotropium | LABA/ICS + Tiotropium | Oral Theophylline |
|---|---|---|---|---|---|---|
| Arm/Group Description | LABA: Indacaterol, once a day, 150μg each time | LAMA: Tiotropium Bromide, once a day, 18 μg | Salmeterol / fluticasone Or budesonide / formoterol | Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg | (Salmeterol / fluticasone Or budesonide / formoterol) + tiotropium | Oral theophylline |
| Measure Participants | 10 | 129 | 597 | 3 | 317 | 87 |
| Mean (Standard Deviation) [Liters] |
0.056
(0.2137)
|
-0.036
(0.2395)
|
0.056
(0.4335)
|
0.030
(0.0854)
|
-0.028
(0.2258)
|
0.046
(0.3654)
|
| Title | COPD Exacerbation |
|---|---|
| Description | 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. |
| Time Frame | Baseline,12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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) |
| Arm/Group Title | Indacaterol | Tiotropium Bromide | Salmeterol/Fluticasone | Budesonide/ Formoterol | LABA/ICS | Indacaterol +Tiotropium | LABA/ICS + Tiotropium | Oral Theophylline |
|---|---|---|---|---|---|---|---|---|
| Arm/Group Description | LABA: Indacaterol, once a day, 150μg each time | LAMA: Tiotropium Bromide, once a day, 18 μg | LABA/ICS: Salmeterol/Fluticasone, twice a day, 50/250 μg, 50/500 μg | Budesonide/formoterol, twice daily, two suction each time, 160/4.5 μg | Salmeterol / fluticasone Or budesonide / formoterol | Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg | (Salmeterol / fluticasone Or budesonide / formoterol) + tiotropium | Oral theophylline |
| Measure Participants | 32 | 276 | 813 | 283 | 1096 | 9 | 632 | 154 |
| Mean (Standard Deviation) [COPD Exacerbations/year] |
1.1
(3.53)
|
0.5
(1.89)
|
1.1
(7.74)
|
0.4
(1.89)
|
0.9
(6.72)
|
4.1
(5.46)
|
0.8
(3.47)
|
1.0
(3.57)
|
| Title | Change in Health Status Questionnaire MMRC |
|---|---|
| Description | 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. |
| Time Frame | Baseline,3,6,9,12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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," |
| Arm/Group Title | Indacaterol | Tiotropium Bromide | LABA/ICS | Indacaterol +Tiotropium | LABA/ICS + Tiotropium | Oral Theophylline |
|---|---|---|---|---|---|---|
| Arm/Group Description | LABA: Indacaterol, once a day, 150μg each time | LAMA: Tiotropium Bromide, once a day, 18 μg | Salmeterol / fluticasone Or budesonide / formoterol | Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg | (Salmeterol / fluticasone Or budesonide / formoterol) + tiotropium | Oral theophylline |
| Measure Participants | 32 | 276 | 1096 | 9 | 632 | 154 |
| Baseline scale item 0 |
4
12.5%
|
40
14.5%
|
161
19.8%
|
1
0.4%
|
63
700%
|
31
4.9%
|
| Baseline scale item 1 |
11
34.4%
|
114
41.3%
|
435
53.5%
|
4
1.4%
|
226
2511.1%
|
66
10.4%
|
| Baseline scale item 2 |
14
43.8%
|
83
30.1%
|
327
40.2%
|
1
0.4%
|
211
2344.4%
|
34
5.4%
|
| Baseline scale item 3 |
3
9.4%
|
36
13%
|
154
18.9%
|
3
1.1%
|
110
1222.2%
|
19
3%
|
| Baseline scale item 4 |
0
0%
|
3
1.1%
|
19
2.3%
|
0
0%
|
22
244.4%
|
4
0.6%
|
| 3 month Scale item 0 |
3
9.4%
|
24
8.7%
|
101
12.4%
|
0
0%
|
54
600%
|
20
3.2%
|
| 3 month Scale item 1 |
9
28.1%
|
69
25%
|
364
44.8%
|
4
1.4%
|
157
1744.4%
|
52
8.2%
|
| 3 month Scale item 2 |
7
21.9%
|
54
19.6%
|
203
25%
|
3
1.1%
|
133
1477.8%
|
26
4.1%
|
| 3 month Scale item 3 |
1
3.1%
|
18
6.5%
|
67
8.2%
|
0
0%
|
58
644.4%
|
11
1.7%
|
| 3 month Scale item 4 |
0
0%
|
2
0.7%
|
6
0.7%
|
0
0%
|
9
100%
|
1
0.2%
|
| 6 month Scale item 0 |
2
6.3%
|
23
8.3%
|
96
11.8%
|
0
0%
|
37
411.1%
|
15
2.4%
|
| 6 month Scale item 1 |
5
15.6%
|
57
20.7%
|
290
35.7%
|
1
0.4%
|
149
1655.6%
|
43
6.8%
|
| 6 month Scale item 2 |
8
25%
|
45
16.3%
|
138
17%
|
4
1.4%
|
105
1166.7%
|
20
3.2%
|
| 6 month Scale item 3 |
1
3.1%
|
13
4.7%
|
54
6.6%
|
1
0.4%
|
44
488.9%
|
4
0.6%
|
| 6 month Scale item 4 |
0
0%
|
3
1.1%
|
5
0.6%
|
0
0%
|
11
122.2%
|
0
0%
|
| 9 month Scale item 0 |
3
9.4%
|
24
8.7%
|
116
14.3%
|
0
0%
|
45
500%
|
20
3.2%
|
| 9 month Scale item 1 |
5
15.6%
|
52
18.8%
|
256
31.5%
|
1
0.4%
|
127
1411.1%
|
40
6.3%
|
| 9 month Scale item 2 |
4
12.5%
|
30
10.9%
|
131
16.1%
|
2
0.7%
|
99
1100%
|
19
3%
|
| 9 month Scale item 3 |
1
3.1%
|
14
5.1%
|
42
5.2%
|
0
0%
|
41
455.6%
|
5
0.8%
|
| 9 month Scale item 4 |
0
0%
|
1
0.4%
|
4
0.5%
|
0
0%
|
9
100%
|
1
0.2%
|
| 12 month Scale item 0 |
1
3.1%
|
24
8.7%
|
150
18.5%
|
0
0%
|
47
522.2%
|
20
3.2%
|
| 12 month Scale item 1 |
5
15.6%
|
61
22.1%
|
275
33.8%
|
2
0.7%
|
138
1533.3%
|
52
8.2%
|
| 12 month Scale item 2 |
2
6.3%
|
33
12%
|
127
15.6%
|
1
0.4%
|
102
1133.3%
|
12
1.9%
|
| 12 month Scale item 3 |
2
6.3%
|
10
3.6%
|
41
5%
|
0
0%
|
32
355.6%
|
4
0.6%
|
| 12 month Scale item 4 |
0
0%
|
3
1.1%
|
9
1.1%
|
0
0%
|
9
100%
|
1
0.2%
|
| Title | Change From Baseline in Questionnaire COPD Assessment Test (CAT) Score |
|---|---|
| Description | 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. |
| Time Frame | Baseline,3,6,9,12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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," |
| Arm/Group Title | Indacaterol | Tiotropium Bromide | LABA/ICS | Indacaterol +Tiotropium | LABA/ICS + Tiotropium | Oral Theophylline |
|---|---|---|---|---|---|---|
| Arm/Group Description | LABA: Indacaterol, once a day, 150μg each time | LAMA: Tiotropium Bromide, once a day, 18 μg | Salmeterol / fluticasone Or budesonide / formoterol | Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg | (Salmeterol / fluticasone Or budesonide / formoterol) + tiotropium | Oral theophylline |
| Measure Participants | 32 | 276 | 1096 | 9 | 632 | 154 |
| 3 Month |
-1.9
(5.12)
|
-2.1
(5.58)
|
-2.3
(5.68)
|
-1.9
(2.67)
|
-1.8
(5.96)
|
-1.8
(4.07)
|
| 6 Month |
-1.9
(5.80)
|
-2.7
(5.78)
|
-2.7
(5.89)
|
-2.7
(5.01)
|
-2.2
(6.46)
|
-2.5
(5.65)
|
| 9 Month |
-4.4
(5.27)
|
-3.1
(6.02)
|
-3.5
(6.66)
|
-9.0
(2.65)
|
-3.1
(6.49)
|
-3.1
(6.27)
|
| 12 Month |
-5.1
(3.98)
|
-2.6
(6.74)
|
-4.1
(7.09)
|
-7.7
(0.58)
|
-3.7
(6.45)
|
-2.4
(7.25)
|
| Title | Change From Baseline Questionnaire Transition Dyspnea Index (TDI) Score |
|---|---|
| Description | 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. |
| Time Frame | Baseline,3,6,9,12 months |
Outcome Measure Data
| Analysis Population Description |
|---|
| 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," |
| Arm/Group Title | Indacaterol | Tiotropium Bromide | LABA/ICS | Indacaterol +Tiotropium | LABA/ICS + Tiotropium | Oral Theophylline |
|---|---|---|---|---|---|---|
| Arm/Group Description | LABA: Indacaterol, once a day, 150μg each time | LAMA: Tiotropium Bromide, once a day, 18 μg | Salmeterol / fluticasone Or budesonide / formoterol | Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg | Salmeterol / fluticasone Or budesonide / formoterol) + tiotropium | Oral theophylline |
| Measure Participants | 32 | 276 | 1096 | 9 | 632 | 154 |
| Baseline |
6.7
(2.27)
|
6.6
(2.66)
|
6.7
(2.66)
|
5.4
(2.24)
|
6.2
(2.60)
|
7.1
(2.81)
|
| 3 Month |
1.4
(2.61)
|
1.2
(2.43)
|
1.3
(2.59)
|
0.4
(2.07)
|
1.1
(2.50)
|
0.9
(2.57)
|
| 6 Month |
0.0
(2.45)
|
1.0
(2.67)
|
1.4
(2.59)
|
-0.5
(2.26)
|
0.9
(2.36)
|
1.2
(2.03)
|
| 9 Month |
0.7
(1.23)
|
0.9
(2.48)
|
1.6
(2.78)
|
1.0
(1.73)
|
0.9
(2.32)
|
1.4
(2.68)
|
| 12 Month |
0.3
(1.70)
|
1.0
(2.91)
|
1.7
(3.09)
|
1.0
(1.73)
|
1.0
(2.57)
|
1.6
(2.44)
|
Adverse Events
| Time Frame | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||||||||||
| Arm/Group Title | Indacaterol | Tiotropium | Salemeterol/Fluticasone | Budesonide/Formoterol | Indacaterol + Tiotropium | Salemeterol/Fluticasone(or Budesonide/Formoterol)+Tiotropium | Oral Theophylline | Other | ||||||||
| Arm/Group Description | Indacaterol | Tiotropium | Salemeterol/Fluticasone | Budesonide/Formoterol | Indacaterol + Tiotropium | Salemeterol/Fluticasone(or Budesonide/Formoterol)+Tiotropium | Oral Theophylline | Other | ||||||||
All Cause Mortality |
||||||||||||||||
| Indacaterol | Tiotropium | Salemeterol/Fluticasone | Budesonide/Formoterol | Indacaterol + Tiotropium | Salemeterol/Fluticasone(or Budesonide/Formoterol)+Tiotropium | Oral Theophylline | Other | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | / (NaN) | ||||||||
Serious Adverse Events |
||||||||||||||||
| Indacaterol | Tiotropium | Salemeterol/Fluticasone | Budesonide/Formoterol | Indacaterol + Tiotropium | Salemeterol/Fluticasone(or Budesonide/Formoterol)+Tiotropium | Oral Theophylline | Other | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 1/32 (3.1%) | 9/276 (3.3%) | 22/813 (2.7%) | 2/283 (0.7%) | 2/9 (22.2%) | 11/632 (1.7%) | 6/154 (3.9%) | 1/30 (3.3%) | ||||||||
| Cardiac disorders | ||||||||||||||||
| Acute coronary syndrome | 0/32 (0%) | 0/276 (0%) | 1/813 (0.1%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Acute left ventricular failure | 0/32 (0%) | 0/276 (0%) | 0/813 (0%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 1/154 (0.6%) | 0/30 (0%) | ||||||||
| Acute myocardial infarction | 0/32 (0%) | 0/276 (0%) | 2/813 (0.2%) | 0/283 (0%) | 0/9 (0%) | 2/632 (0.3%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Atrioventricular block | 0/32 (0%) | 0/276 (0%) | 1/813 (0.1%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Cardiac disorder | 0/32 (0%) | 0/276 (0%) | 0/813 (0%) | 0/283 (0%) | 1/9 (11.1%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Coronary artery disease | 0/32 (0%) | 0/276 (0%) | 0/813 (0%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 1/154 (0.6%) | 0/30 (0%) | ||||||||
| Hypertensive heart disease | 0/32 (0%) | 0/276 (0%) | 1/813 (0.1%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Palpitations | 0/32 (0%) | 0/276 (0%) | 0/813 (0%) | 0/283 (0%) | 0/9 (0%) | 1/632 (0.2%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Unstable angina | 0/32 (0%) | 0/276 (0%) | 1/813 (0.1%) | 0/283 (0%) | 0/9 (0%) | 1/632 (0.2%) | 1/154 (0.6%) | 0/30 (0%) | ||||||||
| Ventricular arrhythmia | 0/32 (0%) | 0/276 (0%) | 1/813 (0.1%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Ear and labyrinth disorders | ||||||||||||||||
| Positional vertigo | 0/32 (0%) | 0/276 (0%) | 1/813 (0.1%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Endocrine disorders | ||||||||||||||||
| Goitre | 0/32 (0%) | 0/276 (0%) | 0/813 (0%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 0/154 (0%) | 1/30 (3.3%) | ||||||||
| Gastrointestinal disorders | ||||||||||||||||
| Gastritis | 0/32 (0%) | 0/276 (0%) | 0/813 (0%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 1/154 (0.6%) | 0/30 (0%) | ||||||||
| Inguinal hernia | 1/32 (3.1%) | 0/276 (0%) | 0/813 (0%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Intestinal obstruction | 0/32 (0%) | 0/276 (0%) | 0/813 (0%) | 1/283 (0.4%) | 0/9 (0%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Upper gastrointestinal haemorrhage | 0/32 (0%) | 1/276 (0.4%) | 0/813 (0%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| General disorders | ||||||||||||||||
| Death | 0/32 (0%) | 1/276 (0.4%) | 2/813 (0.2%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Multi-organ failure | 0/32 (0%) | 0/276 (0%) | 1/813 (0.1%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Sudden cardiac death | 0/32 (0%) | 0/276 (0%) | 0/813 (0%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 1/154 (0.6%) | 0/30 (0%) | ||||||||
| Sudden death | 0/32 (0%) | 0/276 (0%) | 0/813 (0%) | 0/283 (0%) | 0/9 (0%) | 2/632 (0.3%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Infections and infestations | ||||||||||||||||
| Abdominal infection | 0/32 (0%) | 0/276 (0%) | 1/813 (0.1%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Appendicitis | 0/32 (0%) | 1/276 (0.4%) | 0/813 (0%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Bronchitis | 0/32 (0%) | 1/276 (0.4%) | 3/813 (0.4%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Herpes zoster | 0/32 (0%) | 1/276 (0.4%) | 0/813 (0%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Infectious pneumonia | 0/32 (0%) | 2/276 (0.7%) | 0/813 (0%) | 0/283 (0%) | 1/9 (11.1%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Lower respiratory tract infection | 0/32 (0%) | 0/276 (0%) | 1/813 (0.1%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Lung infection | 0/32 (0%) | 0/276 (0%) | 1/813 (0.1%) | 0/283 (0%) | 0/9 (0%) | 1/632 (0.2%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Respiratory tract infection | 0/32 (0%) | 0/276 (0%) | 0/813 (0%) | 0/283 (0%) | 0/9 (0%) | 1/632 (0.2%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Injury, poisoning and procedural complications | ||||||||||||||||
| Hip fracture | 0/32 (0%) | 1/276 (0.4%) | 0/813 (0%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Radius fracture | 0/32 (0%) | 1/276 (0.4%) | 0/813 (0%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Musculoskeletal and connective tissue disorders | ||||||||||||||||
| Rheumatoid arthritis | 0/32 (0%) | 0/276 (0%) | 0/813 (0%) | 0/283 (0%) | 0/9 (0%) | 1/632 (0.2%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Spondyloarthropathy | 0/32 (0%) | 1/276 (0.4%) | 0/813 (0%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||||||||||
| Brain neoplasm | 0/32 (0%) | 0/276 (0%) | 1/813 (0.1%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Malignant lung neoplasm | 0/32 (0%) | 0/276 (0%) | 1/813 (0.1%) | 0/283 (0%) | 0/9 (0%) | 1/632 (0.2%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Neoplasm | 0/32 (0%) | 0/276 (0%) | 1/813 (0.1%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Rectal cancer | 0/32 (0%) | 0/276 (0%) | 0/813 (0%) | 1/283 (0.4%) | 0/9 (0%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Nervous system disorders | ||||||||||||||||
| Cerebral haemorrhage | 0/32 (0%) | 0/276 (0%) | 0/813 (0%) | 0/283 (0%) | 0/9 (0%) | 1/632 (0.2%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Post herpetic neuralgia | 0/32 (0%) | 0/276 (0%) | 1/813 (0.1%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Reproductive system and breast disorders | ||||||||||||||||
| Benign prostatic hyperplasia | 0/32 (0%) | 0/276 (0%) | 1/813 (0.1%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Respiratory, thoracic and mediastinal disorders | ||||||||||||||||
| Bronchiectasis | 0/32 (0%) | 0/276 (0%) | 1/813 (0.1%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Respiratory failure | 0/32 (0%) | 0/276 (0%) | 2/813 (0.2%) | 0/283 (0%) | 0/9 (0%) | 0/632 (0%) | 2/154 (1.3%) | 0/30 (0%) | ||||||||
| Spontaneous pneumothorax | 0/32 (0%) | 0/276 (0%) | 0/813 (0%) | 1/283 (0.4%) | 0/9 (0%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
| Vascular disorders | ||||||||||||||||
| Hypertension | 0/32 (0%) | 0/276 (0%) | 0/813 (0%) | 0/283 (0%) | 1/9 (11.1%) | 0/632 (0%) | 0/154 (0%) | 0/30 (0%) | ||||||||
Other (Not Including Serious) Adverse Events |
||||||||||||||||
| Indacaterol | Tiotropium | Salemeterol/Fluticasone | Budesonide/Formoterol | Indacaterol + Tiotropium | Salemeterol/Fluticasone(or Budesonide/Formoterol)+Tiotropium | Oral Theophylline | Other | |||||||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 2/32 (6.3%) | 1/276 (0.4%) | 14/813 (1.7%) | 1/283 (0.4%) | 1/9 (11.1%) | 5/632 (0.8%) | 1/154 (0.6%) | 1/30 (3.3%) | ||||||||
| Infections and infestations | ||||||||||||||||
| Upper respiratory tract infection | 2/32 (6.3%) | 1/276 (0.4%) | 14/813 (1.7%) | 1/283 (0.4%) | 0/9 (0%) | 4/632 (0.6%) | 1/154 (0.6%) | 1/30 (3.3%) | ||||||||
| Skin and subcutaneous tissue disorders | ||||||||||||||||
| Pruritus | 0/32 (0%) | 0/276 (0%) | 0/813 (0%) | 0/283 (0%) | 1/9 (11.1%) | 1/632 (0.2%) | 0/154 (0%) | 0/30 (0%) | ||||||||
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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.
Results Point of Contact
| Name/Title | Study Director |
|---|---|
| Organization | Novartis Pharmaceutical |
| Phone | 862-778-8300 |
Responsible Party:
Novartis Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01794780
Other Study ID Numbers:
- CQAB149BCN01
First Posted:
Feb 20, 2013
Last Update Posted:
Sep 26, 2019
Last Verified:
Aug 1, 2019