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

NCT01794780 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2229

Last updated 2019-09-26

Study results available
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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.

Conditions

Interventions

DRUG

LABA based treatment: indacaterol

LABA based treatment: indacaterol

DRUG

LAMA based treatment: tiotropium

LAMA based treatment: tiotropium

DRUG

LABA/ICS based treatment: salmeterol/fluticasone

LABA/ICS based treatment: salmeterol/fluticasone

DRUG

LABA/ICS based treatment: budesonide/formoterol

LABA/ICS based treatment: budesonide/formoterol

DRUG

theophylline based treatment

theophylline based treatment

DRUG

Other treatment

non-long-acting bronchodilators for COPD treatment, such treatments were classified as "other treatments"

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-05
Primary Completion
2015-05-25
Completion
2015-05-25

Countries

  • China

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01794780 on ClinicalTrials.gov