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

• Status: Completed
• Trial end date: 2015-05-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Bronchodilator Agents; Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Fluticasone; Formoterol Fumarate; Salmeterol Xinafoate; Theophylline; Tiotropium Bromide

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.