A Phase 3 interventional study of Indacaterol 150 μg and Tiotropium 18 μg in Chronic Obstructive Pulmonary Disease (COPD), sponsored by Novartis Pharmaceuticals. Completed at 138 sites in 12 countries. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2011-08-18.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
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)
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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:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria applied to the study.
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.
Drug: Indacaterol 150 μg · Drug: 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.
Drug: Tiotropium 18 μg · Drug: Placebo to indacaterol
Indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Tiotropium was supplied in powder filled capsules together the manufacture's proprietary inhalation device (HandiHaler®).
Placebo to indacaterol was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
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)
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.
Time frame: From 5 minutes to 8 hours post-dose at the end of treatment (Week 12, Day 84)
Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85)
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of the study (Week 12 + 1 day, Day 85). 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.
Time frame: 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
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 on Day 1. 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.
Time frame: 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
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 2. 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.
Time frame: 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
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose on Day 1. 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.
Time frame: 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)
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose at the end of treatment (Week 12). 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.
Time frame: From 5 minutes to 4 hours post-dose at the end of treatment (Week 12)
| Milestone | Indacaterol 150 μg and Tiotropium 18 μg | Tiotropium 18 μg |
|---|---|---|
| Started | 570 | 564 |
| Received study drug | 570 | 561 |
| Completed | 531 | 529 |
| Not completed | 39 | 35 |
| Withdrew: Adverse event | 20 | 10 |
| Withdrew: Subject withdrew consent | 8 | 10 |
| Withdrew: Administrative problems | 5 | 4 |
| Withdrew: Death | 2 | 0 |
| Withdrew: Protocol deviation | 2 | 6 |
| Withdrew: Abnormal test procedure result(s) | 1 | 0 |
| Withdrew: Lost to follow-up | 1 | 4 |
| Withdrew: Unsatisfactory therapeutic effect | 0 | 1 |
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.
| Liters | Indacaterol 150 μg and Tiotropium 18 μg | Tiotropium 18 μg |
|---|---|---|
| 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) | 1.50 ± 0.014 | 1.38 ± 0.014 |
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 23 hours 10 minutes and 23 hours 45 minutes post-dose at the end of the study (Week 12 + 1 day, Day 85). 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.
| Liters | Indacaterol 150 μg and Tiotropium 18 μg | Tiotropium 18 μg |
|---|---|---|
| Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose at the End of Treatment (Week 12 + 1 Day, Day 85) | 1.38 ± 0.014 | 1.30 ± 0.014 |
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 on Day 1. 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.
| Liters | Indacaterol 150 μg and Tiotropium 18 μg | Tiotropium 18 μg |
|---|---|---|
| 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 | 1.40 ± 0.009 | 1.32 ± 0.009 |
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 23 hours 10 minutes and 23 hours 45 minutes post-dose on Day 2. 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.
| Liters | Indacaterol 150 μg and Tiotropium 18 μg | Tiotropium 18 μg |
|---|---|---|
| Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose on Day 2 | 1.36 ± 0.011 | 1.27 ± 0.012 |
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose on Day 1. 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.
| Liters | Indacaterol 150 μg and Tiotropium 18 μg | Tiotropium 18 μg |
|---|---|---|
| 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 | 1.38 ± 0.008 | 1.31 ± 0.008 |
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5 and 30 minutes; and 1, 2, 3, and 4 hours post-dose at the end of treatment (Week 12). 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.
| Liters | Indacaterol 150 μg and Tiotropium 18 μg | Tiotropium 18 μg |
|---|---|---|
| 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) | 1.52 ± 0.013 | 1.38 ± 0.013 |
Collected over Baseline to the end of the study (Week 12). Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Indacaterol 150 μg and Tiotropium 18 μg | — | 21/570 (3.7%) | 99/570 (17.4%) |
| Tiotropium 18 μg | — | 17/561 (3%) | 69/561 (12.3%) |
| Event | Indacaterol 150 μg and Tiotropium 18 μg | Tiotropium 18 μg |
|---|---|---|
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 6/570 | 11/561 |
| Atrial flutterCardiac disorders | 1/570 | 2/561 |
| PneumoniaInfections and infestations | 2/570 | 2/561 |
| Angina pectorisCardiac disorders | 2/570 | 0/561 |
| Upper respiratory tract infection bacterialInfections and infestations | 2/570 | 0/561 |
| Acute myocardial infarctionCardiac disorders | 1/570 | 1/561 |
| Cardiac failureCardiac disorders | 0/570 | 1/561 |
| Sick sinus syndromeCardiac disorders | 0/570 | 1/561 |
| Upper respiratory tract infectionInfections and infestations | 0/570 | 1/561 |
| Viral upper respiratory tract infectionInfections and infestations | 0/570 | 1/561 |
| Event | Indacaterol 150 μg and Tiotropium 18 μg | Tiotropium 18 μg |
|---|---|---|
| CoughRespiratory, thoracic and mediastinal disorders | 59/570 | 21/561 |
| Chronic obstructive pulmonary diseaseRespiratory, thoracic and mediastinal disorders | 48/570 | 51/561 |
| Age Continuous(years) | Indacaterol 150 μg and Tiotropium 18 μg | Tiotropium 18 μg | Total |
|---|---|---|---|
| Mean | 64.0 ± 9.07 | 63.4 ± 9.22 | 63.7 ± 9.14 |
| Sex: Female, Male(Participants) | Indacaterol 150 μg and Tiotropium 18 μg | Tiotropium 18 μg | Total |
|---|---|---|---|
| Female | 171 | 183 | 354 |
| Male | 399 | 378 | 777 |
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