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

Novartis

Status and phase: Completed; Phase 4

Conditions: COPD

Treatments: Drug: theophylline based treatment; Drug: LAMA based treatment: tiotropium; Drug: LABA/ICS based treatment: budesonide/formoterol; Drug: LABA based treatment: indacaterol; Drug: LABA/ICS based treatment: salmeterol/fluticasone; Drug: Other treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT01794780

CQAB149BCN01

Details and patient eligibility

About

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.

Enrollment: 2,229 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,229 participants in 8 patient groups

Indacaterol

Experimental group

Description:

LABA: Indacaterol, once a day, 150μg each time

Treatment:

Drug: LABA based treatment: indacaterol

Tiotropium Bromide

Experimental group

Description:

LAMA: Tiotropium Bromide, once a day, 18 μg

Treatment:

Drug: LAMA based treatment: tiotropium

Salmeterol/Fluticasone

Experimental group

Description:

LABA/ICS: Salmeterol/Fluticasone, twice a day, 50/250 μg, 50/500 μg

Treatment:

Drug: LABA/ICS based treatment: salmeterol/fluticasone

Budesonide/ formoterol

Experimental group

Description:

Budesonide/formoterol, twice daily, two suction each time, 160/4.5 μg

Treatment:

Drug: LABA/ICS based treatment: budesonide/formoterol

Indacaterol +Tiotropium

Experimental group

Description:

Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg

Treatment:

Drug: LABA based treatment: indacaterol

Drug: LAMA based treatment: tiotropium

LABA/ICS (Or budesonide/ formoterol)+ Tiotropium

Experimental group

Description:

Salmeterol / fluticasone Or budesonide / formoterol

Treatment:

Drug: LABA/ICS based treatment: budesonide/formoterol

Drug: LAMA based treatment: tiotropium

Drug: LABA/ICS based treatment: salmeterol/fluticasone

Oral theophylline

Experimental group

Treatment:

Drug: theophylline based treatment

Other treatment

Experimental group

Description:

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

Treatment:

Drug: Other treatment