A Phase 3 interventional study of Indacaterol 150 μg and Tiotropium 18 μg in Chronic Obstructive Pulmonary Disease, sponsored by Novartis Pharmaceuticals. Completed at 11 sites in Italy. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2016-02-17.
Sponsored by Novartis Pharmaceuticals · Phase 3, Interventional, and Treatment
This study compared the effects of a single dose of indacaterol with that of a single dose of tiotropium on inspiratory capacity.
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This study's enrollment of 54 is below the median of 72 across 2,118 interventional studies indexed under Lung Diseases.
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Diagnosis of moderate (as classified by the Global Initiative for Chronic Obstructive Lung Disease [GOLD] Guidelines, 2007) chronic obstructive pulmonary disease (COPD) and:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria applied to the study.
Patients received indacaterol 150 μg once. After a 5-9 days washout period, patients received tiotropium 18 μg once. After a second 5-9 days washout period, patients received placebo (matching indacaterol) once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
Drug: Indacaterol 150 μg · Drug: Tiotropium 18 μg · Drug: Placebo
Patients received tiotropium 18 μg once. After a 5-9 days washout period, patients received placebo (matching indacaterol) once. After a second 5-9 days washout period, patients received indacaterol 150 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
Drug: Indacaterol 150 μg · Drug: Tiotropium 18 μg · Drug: Placebo
Patients received placebo (matching indacaterol) once. After a 5-9 days washout period, patients received indacaterol 150 μg once. After a second 5-9 days washout period, patients received tiotropium 18 μg once. All treatments were delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
Drug: Indacaterol 150 μg · Drug: Tiotropium 18 μg · Drug: Placebo
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 with a single dose dry powder inhaler (SDDPI) device.
Placebo (matching indacaterol) was supplied in powder filled capsules together with a single dose dry powder inhaler (SDDPI) device.
Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment
During the 4 hours following inhalation of the study treatment, inspiratory capacity (IC) was measured with spirometry conducted according to internationally accepted standards. IC was measured 3 times each at 30, 60, 120, 180, and 240 minutes post-dose and the highest value was reported in liters.
Time frame: 4 hour period following inhalation of study treatment
Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.
Time frame: 4 hour period following inhalation of study treatment
Force Vital Capacity (FVC) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment
FVC was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.
Time frame: 4 hour period following inhalation of study treatment
| Milestone | Indacaterol 150 μg-tiotropium 18 μg-placebo | Tiotropium 18 μg-placebo-indacaterol 150 μg | Placebo-indacaterol 150 μg-tiotropium 18 μg |
|---|---|---|---|
| Started | 19 | 16 | 19 |
| Completed | 17 | 16 | 19 |
| Not completed | 2 | 0 | 0 |
| Withdrew: Subject withdrew consent | 2 | 0 | 0 |
| Milestone | Indacaterol 150 μg-tiotropium 18 μg-placebo | Tiotropium 18 μg-placebo-indacaterol 150 μg | Placebo-indacaterol 150 μg-tiotropium 18 μg |
|---|---|---|---|
| Started | 17 | 16 | 19 |
| Completed | 16 | 16 | 19 |
| Not completed | 1 | 0 | 0 |
| Withdrew: Protocol violation | 1 | 0 | 0 |
| Milestone | Indacaterol 150 μg-tiotropium 18 μg-placebo | Tiotropium 18 μg-placebo-indacaterol 150 μg | Placebo-indacaterol 150 μg-tiotropium 18 μg |
|---|---|---|---|
| Started | 16 | 16 | 19 |
| Completed | 16 | 16 | 19 |
| Not completed | 0 | 0 | 0 |
During the 4 hours following inhalation of the study treatment, inspiratory capacity (IC) was measured with spirometry conducted according to internationally accepted standards. IC was measured 3 times each at 30, 60, 120, 180, and 240 minutes post-dose and the highest value was reported in liters.
| Liters | Indacaterol 150 μg | Tiotropium 18 μg | Placebo |
|---|---|---|---|
| Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment | 2.705 ± 0.676 | 2.630 ± 0.601 | 2.557 ± 0.561 |
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.
| Liters | Indacaterol 150 μg | Tiotropium 18 μg | Placebo |
|---|---|---|---|
| Forced Expiratory Volume in 1 Second (FEV1) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment | 1.744 ± 0.419 | 1.767 ± 0.449 | 1.642 ± 0.409 |
FVC was measured with spirometry conducted according to internationally accepted standards. Measurements were made 30, 60, 120, 180, and 240 minutes post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.
| Liters | Indacaterol 150 μg | Tiotropium 18 μg | Placebo |
|---|---|---|---|
| Force Vital Capacity (FVC) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment | 3.140 ± 0.700 | 3.176 ± 0.788 | 3.048 ± 0.753 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Indacaterol 150 μg | — | 0/54 (0%) | 0/54 (0%) |
| Tiotropium 18 μg | — | 0/52 (0%) | 0/52 (0%) |
| Placebo | — | 0/51 (0%) | 0/51 (0%) |
| Age, Continuous(years) | Entire Study Population |
|---|---|
| Mean | 69.3 ± 9.2 |
| Sex: Female, Male(Participants) | Entire Study Population |
|---|---|
| Female | 5 |
| Male | 49 |
This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.
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