A Phase 4 interventional study of LABA based treatment: indacaterol and LAMA based treatment: tiotropium in COPD, sponsored by Novartis Pharmaceuticals. Completed at 2 sites in China. Per ClinicalTrials.gov, last updated 2019-09-26.
Sponsored by Novartis Pharmaceuticals · Phase 4, Interventional, and Treatment
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's enrollment of 2,229 is above the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
Browse Lung Diseases studies →Novartis Pharmaceuticals is the lead sponsor of 2,673 studies on the registry; 228 are open to participants now.
Of its 576 completed or terminated interventional studies of FDA-regulated products, 431 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
LABA: Indacaterol, once a day, 150μg each time
Drug: LABA based treatment: indacaterol
LAMA: Tiotropium Bromide, once a day, 18 μg
Drug: LAMA based treatment: tiotropium
LABA/ICS: Salmeterol/Fluticasone, twice a day, 50/250 μg, 50/500 μg
Drug: LABA/ICS based treatment: salmeterol/fluticasone
Budesonide/formoterol, twice daily, two suction each time, 160/4.5 μg
Drug: LABA/ICS based treatment: budesonide/formoterol
Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg
Drug: LABA based treatment: indacaterol · Drug: LAMA based treatment: tiotropium
Salmeterol / fluticasone Or budesonide / formoterol
Drug: LAMA based treatment: tiotropium · Drug: LABA/ICS based treatment: salmeterol/fluticasone · Drug: LABA/ICS based treatment: budesonide/formoterol
Drug: theophylline based treatment
non-long-acting bronchodilators for COPD treatment, such treatments were classified as "other treatments"
Drug: Other treatment
LABA based treatment: indacaterol
LAMA based treatment: tiotropium
LABA/ICS based treatment: salmeterol/fluticasone
LABA/ICS based treatment: budesonide/formoterol
theophylline based treatment
non-long-acting bronchodilators for COPD treatment, such treatments were classified as "other treatments"
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.
Time frame: Baseline,3 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline,3,6,9,12 months
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.
| Milestone | Indacaterol | Tiotropium Bromide | Salmeterol/Fluticasone | Budesonide/ Formoterol | Indacaterol +Tiotropium | LABA/ICS (Or Budesonide/ Formoterol)+ Tiotropium | Oral Theophylline | Other Treatment |
|---|---|---|---|---|---|---|---|---|
| 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 |
| Withdrew: Adverse event | 0 | 1 | 2 | 0 | 0 | 0 | 0 | 0 |
| Withdrew: Death | 0 | 2 | 14 | 1 | 0 | 9 | 4 | 0 |
| Withdrew: Lost to follow-up | 10 | 64 | 165 | 53 | 2 | 99 | 30 | 5 |
| Withdrew: Withdrew informed consent | 7 | 17 | 36 | 9 | 0 | 48 | 4 | 3 |
| Withdrew: Other | 0 | 12 | 25 | 20 | 1 | 24 | 4 | 1 |
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.
| Liters | Indacaterol | Tiotropium | LABA/ICS | Indacaterol + Tiotropium | LABA/ICS + Tiotropium | Oral Theophylline |
|---|---|---|---|---|---|---|
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | -0.042 ± 0.1742 | 0.006 ± 0.2537 | 0.033 ± 0.3790 | 0.022 ± 0.1157 | 0.011 ± 0.2417 | 0.012 ± 0.3405 |
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.
| Liters | Indacaterol | Tiotropium Bromide | LABA/ICS | Indacaterol +Tiotropium | LABA/ICS + Tiotropium | Oral Theophylline |
|---|---|---|---|---|---|---|
| Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) | 0.056 ± 0.2137 | -0.036 ± 0.2395 | 0.056 ± 0.4335 | 0.030 ± 0.0854 | -0.028 ± 0.2258 | 0.046 ± 0.3654 |
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.
| COPD Exacerbations/year | Indacaterol | Tiotropium Bromide | Salmeterol/Fluticasone | Budesonide/ Formoterol | LABA/ICS | Indacaterol +Tiotropium | LABA/ICS + Tiotropium | Oral Theophylline |
|---|---|---|---|---|---|---|---|---|
| COPD Exacerbation | 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 |
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.
| Number of participants | Indacaterol | Tiotropium Bromide | LABA/ICS | Indacaterol +Tiotropium | LABA/ICS + Tiotropium | Oral Theophylline |
|---|---|---|---|---|---|---|
| Baseline scale item 0 | 4 | 40 | 161 | 1 | 63 | 31 |
| Baseline scale item 1 | 11 | 114 | 435 | 4 | 226 | 66 |
| Baseline scale item 2 | 14 | 83 | 327 | 1 | 211 | 34 |
| Baseline scale item 3 | 3 | 36 | 154 | 3 | 110 | 19 |
| Baseline scale item 4 | 0 | 3 | 19 | 0 | 22 | 4 |
| 3 month Scale item 0 | 3 | 24 | 101 | 0 | 54 | 20 |
| 3 month Scale item 1 | 9 | 69 | 364 | 4 | 157 | 52 |
| 3 month Scale item 2 | 7 | 54 | 203 | 3 | 133 | 26 |
| 3 month Scale item 3 | 1 | 18 | 67 | 0 | 58 | 11 |
| 3 month Scale item 4 | 0 | 2 | 6 | 0 | 9 | 1 |
| 6 month Scale item 0 | 2 | 23 | 96 | 0 | 37 | 15 |
| 6 month Scale item 1 | 5 | 57 | 290 | 1 | 149 | 43 |
| 6 month Scale item 2 | 8 | 45 | 138 | 4 | 105 | 20 |
| 6 month Scale item 3 | 1 | 13 | 54 | 1 | 44 | 4 |
| 6 month Scale item 4 | 0 | 3 | 5 | 0 | 11 | 0 |
| 9 month Scale item 0 | 3 | 24 | 116 | 0 | 45 | 20 |
| 9 month Scale item 1 | 5 | 52 | 256 | 1 | 127 | 40 |
| 9 month Scale item 2 | 4 | 30 | 131 | 2 | 99 | 19 |
| 9 month Scale item 3 | 1 | 14 | 42 | 0 | 41 | 5 |
| 9 month Scale item 4 | 0 | 1 | 4 | 0 | 9 | 1 |
| 12 month Scale item 0 | 1 | 24 | 150 | 0 | 47 | 20 |
| 12 month Scale item 1 | 5 | 61 | 275 | 2 | 138 | 52 |
| 12 month Scale item 2 | 2 | 33 | 127 | 1 | 102 | 12 |
| 12 month Scale item 3 | 2 | 10 | 41 | 0 | 32 | 4 |
| 12 month Scale item 4 | 0 | 3 | 9 | 0 | 9 | 1 |
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.
| Score on a scale | Indacaterol | Tiotropium Bromide | LABA/ICS | Indacaterol +Tiotropium | LABA/ICS + Tiotropium | Oral Theophylline |
|---|---|---|---|---|---|---|
| 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 |
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.
| Units on a scale | Indacaterol | Tiotropium Bromide | LABA/ICS | Indacaterol +Tiotropium | LABA/ICS + Tiotropium | Oral Theophylline |
|---|---|---|---|---|---|---|
| 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 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Indacaterol | — | 1/32 (3.1%) | 2/32 (6.3%) |
| Tiotropium | — | 9/276 (3.3%) | 1/276 (0.4%) |
| Salemeterol/Fluticasone | — | 22/813 (2.7%) | 14/813 (1.7%) |
| Budesonide/Formoterol | — | 2/283 (0.7%) | 1/283 (0.4%) |
| Indacaterol + Tiotropium | — | 2/9 (22.2%) | 1/9 (11.1%) |
| Salemeterol/Fluticasone(or Budesonide/Formoterol)+Tiotropium | — | 11/632 (1.7%) | 5/632 (0.8%) |
| Oral Theophylline | — | 6/154 (3.9%) | 1/154 (0.6%) |
| Other | — | 1/30 (3.3%) | 1/30 (3.3%) |
| Event | Indacaterol | Tiotropium | Salemeterol/Fluticasone | Budesonide/Formoterol | Indacaterol + Tiotropium | Salemeterol/Fluticasone(or Budesonide/Formoterol)+Tiotropium | Oral Theophylline | Other |
|---|---|---|---|---|---|---|---|---|
| Cardiac disorderCardiac disorders | 0/32 | 0/276 | 0/813 | 0/283 | 1/9 | 0/632 | 0/154 | 0/30 |
| Infectious pneumoniaInfections and infestations | 0/32 | 2/276 | 0/813 | 0/283 | 1/9 | 0/632 | 0/154 | 0/30 |
| HypertensionVascular disorders | 0/32 | 0/276 | 0/813 | 0/283 | 1/9 | 0/632 | 0/154 | 0/30 |
| GoitreEndocrine disorders | 0/32 | 0/276 | 0/813 | 0/283 | 0/9 | 0/632 | 0/154 | 1/30 |
| Inguinal herniaGastrointestinal disorders | 1/32 | 0/276 | 0/813 | 0/283 | 0/9 | 0/632 | 0/154 | 0/30 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 0/32 | 0/276 | 2/813 | 0/283 | 0/9 | 0/632 | 2/154 | 0/30 |
| Acute left ventricular failureCardiac disorders | 0/32 | 0/276 | 0/813 | 0/283 | 0/9 | 0/632 | 1/154 | 0/30 |
| Coronary artery diseaseCardiac disorders | 0/32 | 0/276 | 0/813 | 0/283 | 0/9 | 0/632 | 1/154 | 0/30 |
| Unstable anginaCardiac disorders | 0/32 | 0/276 | 1/813 | 0/283 | 0/9 | 1/632 | 1/154 | 0/30 |
| GastritisGastrointestinal disorders | 0/32 | 0/276 | 0/813 | 0/283 | 0/9 | 0/632 | 1/154 | 0/30 |
| Event | Indacaterol | Tiotropium | Salemeterol/Fluticasone | Budesonide/Formoterol | Indacaterol + Tiotropium | Salemeterol/Fluticasone(or Budesonide/Formoterol)+Tiotropium | Oral Theophylline | Other |
|---|---|---|---|---|---|---|---|---|
| PruritusSkin and subcutaneous tissue disorders | 0/32 | 0/276 | 0/813 | 0/283 | 1/9 | 1/632 | 0/154 | 0/30 |
| Upper respiratory tract infectionInfections and infestations | 2/32 | 1/276 | 14/813 | 1/283 | 0/9 | 4/632 | 1/154 | 1/30 |
| Age, Continuous(Years) | Indacaterol | Tiotropium Bromide | Salmeterol/Fluticasone | Budesonide/ Formoterol | Indacaterol +Tiotropium | LABA/ICS (Or Budesonide/ Formoterol)+ Tiotropium | Oral Theophylline | Other Treatment | Total |
|---|---|---|---|---|---|---|---|---|---|
| Mean | 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(Participants) | Indacaterol | Tiotropium Bromide | Salmeterol/Fluticasone | Budesonide/ Formoterol | Indacaterol +Tiotropium | LABA/ICS (Or Budesonide/ Formoterol)+ Tiotropium | Oral Theophylline | Other Treatment | Total |
|---|---|---|---|---|---|---|---|---|---|
| Female | 1 | 52 | 154 | 49 | 1 | 81 | 35 | 5 | 378 |
| Male | 31 | 224 | 659 | 234 | 8 | 551 | 119 | 25 | 1851 |
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Novartis Pharmaceuticals