This study assessed the efficacy, safety, tolerability, and pharmacokinetics of two different formulations of indacaterol, one administered via the Concept1 device and one administered via the Simoon device. The study aimed to determine whether the novel formulation (Simoon) had a similar profile to that of the established formulation (Concept1).
This study was double-blind with regards to the Concept1, where placebo for the lactose-blended indacaterol was available. However, with regards to the Simoon, neither the subject nor the investigator was blinded due to lack of a placebo to the PulmoSphere formulation. Hence, the overall designation of the study was partially-blind.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
35
Indacaterol maleate 150 μg was provided in powder filled capsules with the Concept1 dry-powder inhaler.
Indacaterol 60 μg was provided in powder filled capsules with the Simoon dry-powder inhaler.
Indacaterol 120 μg was provided in powder filled capsules with the Simoon dry-powder inhaler.
Novartis Investigative Site
Berlin, Germany
Novartis Investigative Site
Groningen, Netherlands
Novartis Investigative Site
Belfast, United Kingdom
Novartis Investigative Site
Manchester, United Kingdom
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose for Each Treatment
FEV1 was measured with spirometry conducted according to internationally accepted standards. Trough FEV1 was defined as the average of measurements made 23 hours 10 minutes and 23 hours 45 minutes post-dose for each treatment.
Time frame: Baseline and Day 1
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1) for Each Treatment
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, 4, 6, 8, and 12 hours post-dose in Day 1.
Time frame: Baseline and Day 1
Time to Peak Forced Expiratory Volume in 1 Second (FEV1) for Each Treatment
FEV1 was measured with spirometry conducted according to internationally accepted standards at 5, 15, and 30 minutes; 1 hour, 1 hour 30 minutes; and 1, 2, 4, 6, 8, and 12 hours post-dose in Day 1.
Time frame: From 5 minutes to 12 hours post-dose
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 for Each Treatment
FEV1 was measured with spirometry conducted according to internationally accepted standards. Measurements were made at 5, 15, and 30 minutes; and 1, 2, and 4 hours post-dose. The standardized AUC FEV1 was calculated as the sum of trapezoids divided by the length of time.
Time frame: From 5 minutes to 4 hours post-dose for each treatment
Indacaterol Exposure (AUC[0-24 Hours]) for Each Treatment
All patients fasted for at least 10 hours prior to administration of study medication and continued to fast for at least 4 hours thereafter. Venous blood samples for pharmacokinetic evaluation were collected at 5, 10, 15, and 30 minutes; and 1, 2, 4, 8, and 24 hours post-dose in each treatment period and were analyzed using a LC-MS/MS assay. Area under the concentration-time curve up to 24 hours (AUC\[0-24 hours\]) was calculated from concentration-time data using non-compartmental analysis.
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Placebo to indacaterol was provided in powder filled capsules with the Concept1 dry-powder inhaler.
Time frame: 0 to 24 hours post-dose
Indacaterol Exposure (Cmax) for Each Treatment
All patients fasted for at least 10 hours prior to administration of study medication and continued to fast for at least 4 hours thereafter. Venous blood samples for pharmacokinetic evaluation were collected at 5, 10, 15, and 30 minutes; and 1, 2, 4, 8, and 24 hours post-dose in each treatment period and were analyzed using a LC-MS/MS assay. Maximum (peak) plasma drug concentration after drug administration (Cmax) was calculated from concentration-time data using non-compartmental analysis.
Time frame: 0 to 24 hours post-dose