A 1-year Multi-center, Prospective, Cohort Study in Patients With Chronic Obstructive Pulmonary Disease Treated With Long-acting Bronchodilator
1 other identifier
interventional
2,229
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Feb 2013
Typical duration for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 5, 2013
CompletedFirst Submitted
Initial submission to the registry
February 15, 2013
CompletedFirst Posted
Study publicly available on registry
February 20, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 25, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 25, 2015
CompletedResults Posted
Study results publicly available
September 26, 2019
CompletedSeptember 26, 2019
August 1, 2019
2.3 years
February 15, 2013
June 1, 2017
August 27, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 (5)
Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
Baseline,12 months
COPD Exacerbation
Baseline,12 months
Change in Health Status Questionnaire MMRC
Baseline,3,6,9,12 months
Change From Baseline in Questionnaire COPD Assessment Test (CAT) Score
Baseline,3,6,9,12 months
Change From Baseline Questionnaire Transition Dyspnea Index (TDI) Score
Baseline,3,6,9,12 months
Study Arms (8)
Indacaterol
EXPERIMENTALLABA: Indacaterol, once a day, 150μg each time
Tiotropium Bromide
EXPERIMENTALLAMA: Tiotropium Bromide, once a day, 18 μg
Salmeterol/Fluticasone
EXPERIMENTALLABA/ICS: Salmeterol/Fluticasone, twice a day, 50/250 μg, 50/500 μg
Budesonide/ formoterol
EXPERIMENTALBudesonide/formoterol, twice daily, two suction each time, 160/4.5 μg
Indacaterol +Tiotropium
EXPERIMENTALIndacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg
LABA/ICS (Or budesonide/ formoterol)+ Tiotropium
EXPERIMENTALSalmeterol / fluticasone Or budesonide / formoterol
Oral theophylline
EXPERIMENTALOther treatment
EXPERIMENTALnon-long-acting bronchodilators for COPD treatment, such treatments were classified as "other treatments"
Interventions
LABA based treatment: indacaterol
LAMA based treatment: tiotropium
LABA/ICS based treatment: salmeterol/fluticasone
LABA/ICS based treatment: budesonide/formoterol
non-long-acting bronchodilators for COPD treatment, such treatments were classified as "other treatments"
Eligibility Criteria
You may qualify if:
- Willing and able to provide informed consent
- Physician-diagnosis of COPD
- COPD patients requiring long-acting bronchodilator treatment
- Patients with spirometry available at baseline
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Novartis Investigative Site
Beijing, 100730, China
Novartis Investigative Site
Zhengzhou, China
Related Publications (1)
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.
PMID: 25474373DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study Director
- Organization
- Novartis Pharmaceutical
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2013
First Posted
February 20, 2013
Study Start
February 5, 2013
Primary Completion
May 25, 2015
Study Completion
May 25, 2015
Last Updated
September 26, 2019
Results First Posted
September 26, 2019
Record last verified: 2019-08