Phase 3 Completed N=186 Randomized Treatment

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

Chronic Obstructive Pulmonary Disease

Source: ClinicalTrials.gov NCT00876694 ↗

Enrolled (actual)

186

Serious AEs

10.8%

Results posted

Nov 2011

Primary outcomePrimary: The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment — 1; 0; 0; 0 Participants

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY The Number of Participants With a Clinically Notable Pulse Rate During 52 Weeks of Treatment	1; 0; 0; 0	—
PRIMARY The Number of Participants With a Clinically Notable Systolic Blood Pressure During 52 Weeks of Treatment	0; 0; 1; 0	—
PRIMARY The Number of Participants With a Clinically Notable Diastolic Blood Pressure During 52 Weeks of Treatment	0; 1; 0; 0	—
PRIMARY The Number of Participants With a Clinically Notable QTc Interval Value During 52 Weeks of Treatment	6; 3; 12; 3; 0; 1	—
PRIMARY Serum Potassium (mmol/L) at Weeks 4, 8, 12, 24, 36, 44, and 52	4.26; 4.28; 4.30; 4.27; 4.28; 4.35	—
PRIMARY Blood Glucose (mmol/L) 1 Hour Post Dose at Weeks 4, 8, 12, 24, 36, 44, and 52	6.10; 5.96; 5.92; 6.30; 5.97; 6.59	—
SECONDARY Trough Forced Expiratory Volume in 1 Second (FEV1) After 12, 24 and 52 Weeks	1.40; 1.33; 1.40; 1.34; 1.39; 1.31	—

Eligibility Criteria

Inclusion Criteria

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

Patients who have been hospitalized for a COPD exacerbation in the 6 weeks prior to Visit 1 or during the run-in period
Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1
Patients with concomitant pulmonary disease
Patients with a history of asthma
Patients with diabetes Type I or uncontrolled diabetes Type II
Any patient with lung cancer or a history of lung cancer
Patients with a history of certain cardiovascular comorbid conditions
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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00876694). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.