Phase 4
Completed N=2,229
A 1-year Multi-center, Prospective, Cohort Study in Patients With Chronic Obstructive Pulmonary Disease Treated With Long-acting Bronchodilator
Source: ClinicalTrials.gov NCT01794780 ↗Enrolled (actual)
2,229
Serious AEs
2.4%
Results posted
Sep 2019
Primary outcomePrimary: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) — -0.042; 0.006; 0.033; 0.022 Liters
◆ Published Evidence
Established
26citations · ~2 / year
Breathlessness or health status in chronic obstructive pulmonary disease: the impact of different definitions.
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.
Linked Publications
-
Breathlessness or health status in chronic obstructive pulmonary disease: the impact of different definitions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) |
0.056; -0.036; 0.056; 0.030; -0.028; 0.046 | — |
| SECONDARY Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) |
0.056; -0.036; 0.056; 0.030; -0.028; 0.046 | — |
| SECONDARY COPD Exacerbation |
1.1; 0.5; 1.1; 0.4; 0.9; 4.1 | — |
| SECONDARY Change in Health Status Questionnaire MMRC |
4; 40; 161; 1; 63; 31 | — |
| SECONDARY Change From Baseline in Questionnaire COPD Assessment Test (CAT) Score |
-1.9; -2.1; -2.3; -1.9; -1.8; -1.8 | — |
| SECONDARY Change From Baseline Questionnaire Transition Dyspnea Index (TDI) Score |
6.7; 6.6; 6.7; 5.4; 6.2; 7.1 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01794780) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.