A 1-year Multi-center, Prospective, Cohort Study in Patients With Chronic Obstructive Pulmonary Disease Treated With Long-acting Bronchodilator

Study Overview
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Brief Summary
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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.

Official Title
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A 1-year Multi-center, Prospective, Cohort Study in Patients With Chronic Obstructive Pulmonary Disease Treated With Long-acting Bronchodilator

Conditions
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COPD

Intervention / Treatment
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* Drug: LABA based treatment: indacaterol
* Drug: LAMA based treatment: tiotropium
* Drug: LABA/ICS based treatment: salmeterol/fluticasone
* Drug: LABA/ICS based treatment: budesonide/formoterol
* Drug: theophylline based treatment
* Drug: Other treatment


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Indacaterol<br>LABA: Indacaterol, once a day, 150μg each time | Drug: LABA based treatment: indacaterol<br>* LABA based treatment: indacaterol<br>|
| Experimental: Tiotropium Bromide<br>LAMA: Tiotropium Bromide, once a day, 18 μg | Drug: LAMA based treatment: tiotropium<br>* LAMA based treatment: tiotropium<br>|
| Experimental: Salmeterol/Fluticasone<br>LABA/ICS: Salmeterol/Fluticasone, twice a day, 50/250 μg, 50/500 μg | Drug: LABA/ICS based treatment: salmeterol/fluticasone<br>* LABA/ICS based treatment: salmeterol/fluticasone<br>|
| Experimental: Budesonide/ formoterol<br>Budesonide/formoterol, twice daily, two suction each time, 160/4.5 μg | Drug: LABA/ICS based treatment: budesonide/formoterol<br>* LABA/ICS based treatment: budesonide/formoterol<br>|
| Experimental: Indacaterol +Tiotropium<br>Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg | Drug: LABA based treatment: indacaterol<br>* LABA based treatment: indacaterol<br>Drug: LAMA based treatment: tiotropium<br>* LAMA based treatment: tiotropium<br>|
| Experimental: LABA/ICS (Or budesonide/ formoterol)+ Tiotropium<br>Salmeterol / fluticasone Or budesonide / formoterol | Drug: LAMA based treatment: tiotropium<br>* LAMA based treatment: tiotropium<br>Drug: LABA/ICS based treatment: salmeterol/fluticasone<br>* LABA/ICS based treatment: salmeterol/fluticasone<br>Drug: LABA/ICS based treatment: budesonide/formoterol<br>* LABA/ICS based treatment: budesonide/formoterol<br>|
| Experimental: Oral theophylline<br> | Drug: theophylline based treatment<br>* theophylline based treatment<br>|
| Experimental: Other treatment<br>non-long-acting bronchodilators for COPD treatment, such treatments were classified as other treatments | Drug: Other treatment<br>* non-long-acting bronchodilators for COPD treatment, such treatments were classified as other treatments<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Outcome Measures

| Outcome Measure | 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,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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, Chronic obstructive pulmonary disease (COPD),, Chronic obstructive lung disease (COLD),, Chronic obstructive airway disease (COAD),, Cronchitis,, Emphysema