CompletedPhase 4

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

China2,229 participantsStarted 2013-02-05

Plain-language 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.

Who can participate

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1)

Timeframe: Baseline,3 months

Trial details

NCT IDNCT01794780

SponsorNovartis Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2015-05-25

Results submitted2017-06-01

View on ClinicalTrials.gov More COPD trials

Plain-language summary

Who can participate

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.