Confirmatory Study of Indacaterol in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Novartis

Status and phase: Completed; Phase 3

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Treatments: Drug: Indacaterol 300 µg; Drug: Salmeterol 50 µg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00876694

CQAB149B1303

Details and patient eligibility

About

This study is designed to collect long term safety data of indacaterol (300 µg o.d.) in Japanese patients with moderate to severe COPD. Data from this study will be used for the registration of indacaterol in Japan.

Enrollment: 186 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines) and:

• Smoking history of at least 20 pack-years
• Post-bronchodilator FEV1 <80% and ≥30% of the predicted normal value
• Post-bronchodilator FEV1/FVC (forced vital capacity) <70%

Exclusion criteria

1. Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
2. Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1
3. Patients with concomitant pulmonary disease
4. Patients with a history of asthma
5. Patients with diabetes Type I or uncontrolled diabetes Type II
6. Any patient with lung cancer or a history of lung cancer
7. Patients with a history of certain cardiovascular comorbid conditions
8. Patients who have been exposed to indacaterol previously. (Except for any patient who enrolled in Study CQAB149B1302)

Other protocol-defined inclusion/exclusion criteria may apply

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

186 participants in 2 patient groups

Indacaterol 300 µg

Experimental group

Description:

Indacaterol 300 μg once a day (o.d.) delivered via single dose dry powder inhaler (SDDPI). Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.

Treatment:

Drug: Indacaterol 300 µg

Salmeterol 50 µg

Active Comparator group

Description:

Salmeterol 50 μg twice a day (b.i.d.) delivered via Diskus®. Daily ICS monotherapy, if needed, was allowed to remain stable throughout study. Salbutamol was available for rescue use throughout study.

Treatment:

Drug: Salmeterol 50 µg