Trial Outcomes & Findings for Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity (NCT NCT00999908)

Last Updated: 2016-02-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

54 participants

Primary outcome timeframe

4 hour period following inhalation of study treatment

Results posted on

2016-02-17

Participant Flow

Participant milestones

Participant milestones
Measure	Indacaterol 150 μg-tiotropium 18 μg-placebo 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.	Tiotropium 18 μg-placebo-indacaterol 150 μg 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.	Placebo-indacaterol 150 μg-tiotropium 18 μg 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.
Treatment Period 1 STARTED	19	16	19
Treatment Period 1 COMPLETED	17	16	19
Treatment Period 1 NOT COMPLETED	2	0	0
Treatment Period 2 STARTED	17	16	19
Treatment Period 2 COMPLETED	16	16	19
Treatment Period 2 NOT COMPLETED	1	0	0
Treatment Period 3 STARTED	16	16	19
Treatment Period 3 COMPLETED	16	16	19
Treatment Period 3 NOT COMPLETED	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Indacaterol 150 μg-tiotropium 18 μg-placebo 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.	Tiotropium 18 μg-placebo-indacaterol 150 μg 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.	Placebo-indacaterol 150 μg-tiotropium 18 μg 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.
Treatment Period 1 Subject withdrew consent	2	0	0
Treatment Period 2 Protocol Violation	1	0	0

Baseline Characteristics

Comparison of the Effects of Indacaterol and Tiotropium on Inspiratory Capacity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Entire Study Population n=54 Participants The entire study population includes the 3 groups of patients who received indacaterol 150 μg, tiotropium 18 μg, and placebo (matching indacaterol) once each in 1 of 3 different orders in this crossover study. 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.
Age, Continuous	69.3 years STANDARD_DEVIATION 9.2 • n=93 Participants
Sex: Female, Male Female	5 Participants n=93 Participants
Sex: Female, Male Male	49 Participants n=93 Participants

PRIMARY outcome

Timeframe: 4 hour period following inhalation of study treatment

Population: Per protocol population: All randomized patients who received all the study drugs and had at least 1 post-dose inspiratory capacity measurement within 4 hours after inhalation in each treatment period and who were compliant with the protocol and without any major deviation likely to affect the analysis of pulmonary function measurements.

Outcome measures

Outcome measures
Measure	Indacaterol 150 μg n=44 Participants Patients received indacaterol 150 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.	Tiotropium 18 μg n=44 Participants Patients received tiotropium 18 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.	Placebo n=44 Participants Patients received placebo (matching indacaterol) once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
Peak Inspiratory Capacity Assessed With Spirometry in the 4 Hours After Treatment	2.705 Liters Standard Deviation 0.676	2.630 Liters Standard Deviation 0.601	2.557 Liters Standard Deviation 0.561

SECONDARY outcome

Timeframe: 4 hour period following inhalation of study treatment

Population: Intent-to-treat population: All randomized patients who received all the study drugs and had at least 1 post-dose inspiratory capacity measurement within 4 hours after inhalation in each treatment period.

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.

Outcome measures

Outcome measures
Measure	Indacaterol 150 μg n=49 Participants Patients received indacaterol 150 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.	Tiotropium 18 μg n=49 Participants Patients received tiotropium 18 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.	Placebo n=49 Participants Patients received placebo (matching indacaterol) once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
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 Liters Standard Deviation 0.419	1.767 Liters Standard Deviation 0.449	1.642 Liters Standard Deviation 0.409

SECONDARY outcome

Timeframe: 4 hour period following inhalation of study 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.

Outcome measures

Outcome measures
Measure	Indacaterol 150 μg n=49 Participants Patients received indacaterol 150 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.	Tiotropium 18 μg n=49 Participants Patients received tiotropium 18 μg once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.	Placebo n=49 Participants Patients received placebo (matching indacaterol) once, delivered via a single dose dry powder inhaler (SDDPI). The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
Force Vital Capacity (FVC) Standardized (With Respect to Length of Time) Area Under the Curve (AUC) in the 4 Hours After Treatment	3.140 Liters Standard Deviation 0.700	3.176 Liters Standard Deviation 0.788	3.048 Liters Standard Deviation 0.753

Adverse Events

Indacaterol 150 μg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Tiotropium 18 μg

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Study Director

Novartis Pharmaceuticals

Phone: 862 778-8300

Results disclosure agreements

Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (ie, data from all sites) in the clinical trial.
Publication restrictions are in place

Restriction type: OTHER