Conditions: COPD
Keywords: COPD Chronic obstructive pulmonary disease (COPD), Chronic obstructive lung disease (COLD), Chronic obstructive airway disease (COAD), Cronchitis, Emphysema
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 2229
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: LABA: Indacaterol, once a day, 150μg each time arm 2: LAMA: Tiotropium Bromide, once a day, 18 μg arm 3: LABA/ICS: Salmeterol/Fluticasone, twice a day, 50/250 μg, 50/500 μg arm 4: Budesonide/formoterol, twice daily, two suction each time, 160/4.5 μg arm 5: Indacaterol, once a day, 150μg each time +Tiotropium Bromide, once a day, 18 μg arm 6: Salmeterol / fluticasone Or budesonide / formoterol arm 7: None arm 8: non-long-acting bronchodilators for COPD treatment, such treatments were classified as "other treatments"

Interventions: intervention 1: LABA based treatment: indacaterol intervention 2: LAMA based treatment: tiotropium intervention 3: LABA/ICS based treatment: salmeterol/fluticasone intervention 4: LABA/ICS based treatment: budesonide/formoterol intervention 5: theophylline based treatment intervention 6: Other treatment
Intervention descriptions: intervention 1: LABA based treatment: indacaterol intervention 2: LAMA based treatment: tiotropium intervention 3: LABA/ICS based treatment: salmeterol/fluticasone intervention 4: LABA/ICS based treatment: budesonide/formoterol intervention 5: theophylline based treatment intervention 6: non-long-acting bronchodilators for COPD treatment, such treatments were classified as "other treatments"

Protocol document: