Phase 3 Completed N=1,598 Randomized Double-blind Treatment

A Study to Compare the Lung Effect of Indacaterol and Tiotropium in Chronic Obstructive Pulmonary Disease (COPD)

Chronic Obstructive Pulmonary Disease

Source: ClinicalTrials.gov NCT00900731 ↗

Enrolled (actual)

1,598

Serious AEs

3.3%

Results posted

Aug 2011

Primary outcomePrimary: Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12) — 1.44; 1.43 Liters

Summary

This study compared the lung effects of indacaterol to those of tiotropium in patients with moderate to severe chronic obstructive pulmonary disease (COPD) over a 12 week period.

Outcome Measures

Outcome	Result	p-value
PRIMARY Trough Forced Expiratory Volume in 1 Second (FEV1) at End of Treatment (Week 12)	1.44; 1.43	—
SECONDARY Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12)	1.51; 1.52	—
SECONDARY Transition Dyspnea Index (TDI) Focal Score After 12 Weeks of Treatment	2.01; 1.43	—
SECONDARY Quality of Life Assessment With St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 Weeks of Treatment	37.1; 39.2	—
SECONDARY Change From Baseline in the Mean Number of Puffs Per Day of Rescue Medication Over the Study Duration (From Day 1 to Week 12)	-1.40; -0.85	—
SECONDARY Change From Baseline in the Mean Number Per Day of Daytime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12)	-0.90; -0.59	—
SECONDARY Change From Baseline in the Mean Number Per Day of Nighttime Puffs of Rescue Medication Over the Study Duration (From Day 1 to Week 12)	-0.52; -0.28	—
SECONDARY Percentage of Days With no Rescue Medication Use During the 12 Weeks of Treatment	46.1; 41.4	—

Eligibility Criteria

Inclusion Criteria

Diagnosis of COPD (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease (GOLD) Guidelines, 2007) and:
a) Smoking history of at least 10 pack-years
b) Post-bronchodilator forced expiratory volume in 1 second (FEV1) < 80% and ≥ 30% of the predicted normal value
c) Post-bronchodilator FEV1/FVC (forced vital capacity) < 70%

Exclusion Criteria

Patients who have received systemic corticosteroids or antibiotics and/or was hospitalized for a COPD exacerbation in the 6 weeks prior to screening
Patients who have had a respiratory tract infection within 6 weeks prior to screening
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

Other protocol-defined inclusion/exclusion criteria applied to the study.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00900731). 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.