Clinical trial NCT01794780: A 1-year Multi-center, Prospective, Cohort Study in Patients With Chronic Obstructive Pulmonary Disease Treated With Long-acting Bronchodilator
Official title: A 1-year Multi-center, Prospective, Cohort Study in Patients With Chronic Obstructive Pulmonary Disease Treated With Long-acting Bronchodilator
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: COPD
Keywords: COPD
Chronic obstructive pulmonary disease (COPD),
Chronic obstructive lung disease (COLD),
Chronic obstructive airway disease (COAD),
Cronchitis,
Emphysema
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-02-20
Enrollment: 2229
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline,3 months
Secondary outcomes:
measure: Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline,12 months
measure: COPD Exacerbation
timeFrame: Baseline,12 months
measure: Change in Health Status Questionnaire MMRC
timeFrame: Baseline,3,6,9,12 months
measure: Change From Baseline in Questionnaire COPD Assessment Test (CAT) Score
timeFrame: Baseline,3,6,9,12 months
measure: Change From Baseline Questionnaire Transition Dyspnea Index (TDI) Score
timeFrame: Baseline,3,6,9,12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: Novartis Investigative Site
city: Zhengzhou
country: China
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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.