A Randomized, Double-blind, Controlled, Parallel-group, 12-week Study to Compare the Efficacy and Safety of the Combination of Indacaterol 150 µg Once Daily With Open Label Tiotropium 18 µg Once Daily Versus Open Label Tiotropium 18 µg Once Daily in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease

Novartis Pharmaceuticals5 sites in 4 countries1,134 target enrollmentMarch 2009

ConditionsChronic Obstructive Pulmonary Disease (COPD)

InterventionsIndacaterol 150 μg Tiotropium 18 μg Placebo to indacaterol

DrugsIndacaterol 150 μg Tiotropium 18 μg Placebo to indacaterol

Overview

Phase: Phase 3
Intervention: Indacaterol 150 μg
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Sponsor: Novartis Pharmaceuticals
Enrollment: 1134
Locations: 5
Primary Endpoint: Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of Treatment (Week 12)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This study assessed the efficacy and safety of indacaterol (150 µg once daily [od]) when combined with tiotropium (18 µg od) versus tiotropium (18 µg od) treatment alone in patients with chronic obstructive pulmonary disease (COPD)

Registry

clinicaltrials.gov

Start Date

March 2009

End Date

March 2010

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Novartis Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

•Diagnosis of chronic obstructive pulmonary disease (COPD) (moderate-to-severe as classified by the Global Initiative for Chronic Obstructive Lung Disease \[GOLD\] Guidelines, 2007) and:
•Smoking history of at least 10 pack-years
•Post-bronchodilator forced expiratory volume in 1 second (FEV1) ≤ 65% and ≥ 30% of the predicted normal value
•Post-bronchodilator FEV1/FVC (force vital capacity) \< 70%

Exclusion Criteria

•Patients who have had a COPD exacerbation requiring systemic glucocorticosteroid treatment or antibiotics and/or hospitalization in the 6 weeks prior to screening or during the run-in period
•Patients who have had a respiratory tract infection within 6 weeks prior to screening or during the run-in period
•Patients with a body mass index less than 15 or more than 40 kg/m\^2
•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.

Arms & Interventions

Indacaterol 150 μg and tiotropium 18 μg

Patients inhaled indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Intervention: Indacaterol 150 μg

Indacaterol 150 μg and tiotropium 18 μg

Intervention: Tiotropium 18 μg

Tiotropium 18 μg

Patients inhaled placebo to indacaterol 150 μg and tiotropium 18 μg once daily in the morning between 8:00 AM and 11:00 AM for 12 weeks. Placebo to indacaterol was delivered blinded via a single dose dry powder inhaler (SDDPI). Tiotropium was delivered open-label via the manufacturer's proprietary inhalation device (HandiHaler®). Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.

Intervention: Tiotropium 18 μg

Tiotropium 18 μg

Intervention: Placebo to indacaterol

Outcomes

Primary Outcomes

Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose at the End of Treatment (Week 12)

Time Frame: From 5 minutes to 8 hours post-dose at the end of treatment (Week 12, Day 84)

FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, 4, 6, and 8 hours post-dose at the end of the study (Week 12, Day 84). Standardized FEV1 AUC was calculated by the trapezoidal rule. The analysis included baseline FEV1, FEV1 pre-dose and 10-15 minutes post-dose of salbutamol/albuterol during screening, and FEV1 pre-dose and 1 hour post-dose of ipratropium during screening as covariates.

Secondary Outcomes

Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)(24 hours post-dose at the end of treatment (Week 12 + 1 day, Day 85))
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 8 Hours Post-dose on Day 1(From 5 minutes to 8 hours post-dose on Day 1)
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2(24 hours post-dose on Day 2)
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose on Day 1(From 5 minutes to 4 hours post-dose on Day 1)
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours Post-dose at the End of Treatment (Week 12)(From 5 minutes to 4 hours post-dose at the end of treatment (Week 12))