Trial Outcomes & Findings for Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Maleate Via Concept1 or Simoon Devices (NCT NCT01012739)
NCT ID: NCT01012739
Last Updated: 2011-08-29
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
35 participants
Primary outcome timeframe
Baseline and Day 1
Results posted on
2011-08-29
Participant Flow
Participant milestones
| Measure |
Indacaterol 150μg-placebo-Indacaterol 60μg-Indacaterol 120μg
In treatment period 1, patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI); in treatment period 2, patients received placebo to indacaterol via the Concept1 DPI; in treatment period 3, patients received indacaterol 60 μg via the Simoon DPI; and in treatment period 4, patients received indacaterol 120 μg via the Simoon DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 60μg-Indacaterol 150μg-Indacaterol 120μg-placebo
In treatment period 1, patients received indacaterol 60 μg via the Simoon dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 150 μg via the Concept1 DPI; in treatment period 3, patients received indacaterol 120 μg via the Simoon DPI; and in treatment period 4, patients received placebo to indacaterol via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 120μg-Indacaterol 60μg-placebo-Indacaterol 150μg
In treatment period 1, patients received indacaterol 120 μg via the Simoon dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 60 μg via the Simoon DPI; in treatment period 3, patients received placebo to indacaterol via the Concept1 DPI; and in treatment period 4, patients received indacaterol 150 μg via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Placebo-Indacaterol 120μg- Indacaterol 150μg- Indacaterol 60μg
In treatment period 1, patients received placebo to indacaterol via the Concept1 dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 120 μg via the Simoon DPI; in treatment period 3, patients received indacaterol 150 μg via the Concept1 DPI; and in treatment period 4, patients received indacaterol 60 μg via the Simoon DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Treatment Period 1
STARTED
|
9
|
8
|
9
|
9
|
|
Treatment Period 1
COMPLETED
|
9
|
8
|
9
|
8
|
|
Treatment Period 1
NOT COMPLETED
|
0
|
0
|
0
|
1
|
|
Treatment Period 2
STARTED
|
9
|
8
|
9
|
8
|
|
Treatment Period 2
COMPLETED
|
9
|
8
|
9
|
7
|
|
Treatment Period 2
NOT COMPLETED
|
0
|
0
|
0
|
1
|
|
Treatment Period 3
STARTED
|
9
|
8
|
9
|
7
|
|
Treatment Period 3
COMPLETED
|
9
|
8
|
9
|
7
|
|
Treatment Period 3
NOT COMPLETED
|
0
|
0
|
0
|
0
|
|
Treatment Period 4
STARTED
|
9
|
8
|
9
|
7
|
|
Treatment Period 4
COMPLETED
|
9
|
8
|
9
|
7
|
|
Treatment Period 4
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
Indacaterol 150μg-placebo-Indacaterol 60μg-Indacaterol 120μg
In treatment period 1, patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI); in treatment period 2, patients received placebo to indacaterol via the Concept1 DPI; in treatment period 3, patients received indacaterol 60 μg via the Simoon DPI; and in treatment period 4, patients received indacaterol 120 μg via the Simoon DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 60μg-Indacaterol 150μg-Indacaterol 120μg-placebo
In treatment period 1, patients received indacaterol 60 μg via the Simoon dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 150 μg via the Concept1 DPI; in treatment period 3, patients received indacaterol 120 μg via the Simoon DPI; and in treatment period 4, patients received placebo to indacaterol via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 120μg-Indacaterol 60μg-placebo-Indacaterol 150μg
In treatment period 1, patients received indacaterol 120 μg via the Simoon dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 60 μg via the Simoon DPI; in treatment period 3, patients received placebo to indacaterol via the Concept1 DPI; and in treatment period 4, patients received indacaterol 150 μg via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Placebo-Indacaterol 120μg- Indacaterol 150μg- Indacaterol 60μg
In treatment period 1, patients received placebo to indacaterol via the Concept1 dry-powder inhaler (DPI); in treatment period 2, patients received indacaterol 120 μg via the Simoon DPI; in treatment period 3, patients received indacaterol 150 μg via the Concept1 DPI; and in treatment period 4, patients received indacaterol 60 μg via the Simoon DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Treatment Period 1
Adverse Event
|
0
|
0
|
0
|
1
|
|
Treatment Period 2
Abnormal test procedure results
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Efficacy, Safety, Tolerability, and Pharmacokinetics of Indacaterol Maleate Via Concept1 or Simoon Devices
Baseline characteristics by cohort
| Measure |
Entire Study Population
n=35 Participants
The entire study population included all 4 treatment groups who received indacaterol 150 µg via the Concept1 dry-powder inhaler (DPI), indacaterol 60 µg via the Simoon DPI, indacaterol 120 µg via the Simoon DPI, and placebo to indacaterol via the Concept1 DPI. Patients received each treatment only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
|---|---|
|
Age Continuous
|
42.6 years
STANDARD_DEVIATION 11.42 • n=93 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=93 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=93 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 1Population: Pharmacodynamic analysis set: All randomized patients that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.
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.
Outcome measures
| Measure |
Indacaterol 150 μg
n=33 Participants
Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI) only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 60 μg
n=33 Participants
Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 120 μg
n=34 Participants
Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Placebo to Indacaterol
n=35 Participants
Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Change From Baseline in Trough Forced Expiratory Volume in 1 Second (FEV1) 24 Hours Post-dose for Each Treatment
|
2.97 Liters
Standard Deviation 0.695
|
2.93 Liters
Standard Deviation 0.688
|
2.91 Liters
Standard Deviation 0.734
|
2.77 Liters
Standard Deviation 0.67
|
SECONDARY outcome
Timeframe: Baseline and Day 1Population: Pharmacodynamic analysis set: All randomized patients that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.
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.
Outcome measures
| Measure |
Indacaterol 150 μg
n=33 Participants
Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI) only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 60 μg
n=33 Participants
Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 120 μg
n=34 Participants
Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Placebo to Indacaterol
n=35 Participants
Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Change From Baseline in Peak Forced Expiratory Volume in 1 Second (FEV1) for Each Treatment
|
3.19 Liters
Standard Deviation 0.747
|
3.15 Liters
Standard Deviation 0.745
|
3.15 Liters
Standard Deviation 0.717
|
2.96 Liters
Standard Deviation 0.682
|
SECONDARY outcome
Timeframe: From 5 minutes to 12 hours post-dosePopulation: Pharmacodynamic analysis set: All randomized patients that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.
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.
Outcome measures
| Measure |
Indacaterol 150 μg
n=33 Participants
Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI) only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 60 μg
n=33 Participants
Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 120 μg
n=34 Participants
Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Placebo to Indacaterol
n=35 Participants
Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Time to Peak Forced Expiratory Volume in 1 Second (FEV1) for Each Treatment
|
6.80 Hours
Standard Deviation 7.614
|
8.22 Hours
Standard Deviation 7.990
|
7.50 Hours
Standard Deviation 7.370
|
7.93 Hours
Standard Deviation 7.747
|
SECONDARY outcome
Timeframe: From 5 minutes to 4 hours post-dose for each treatmentPopulation: Pharmacodynamic analysis set: All randomized patients that received at least 1 dose of study drug and had a baseline and at least 1 post-baseline measurement of FEV1.
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.
Outcome measures
| Measure |
Indacaterol 150 μg
n=33 Participants
Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI) only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 60 μg
n=33 Participants
Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 120 μg
n=34 Participants
Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Placebo to Indacaterol
n=35 Participants
Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. 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) From 5 Minutes to 4 Hours Post-dose for Each Treatment
|
3.03 Liters
Standard Deviation 0.743
|
2.96 Liters
Standard Deviation 0.732
|
2.99 Liters
Standard Deviation 0.722
|
2.78 Liters
Standard Deviation 0.651
|
SECONDARY outcome
Timeframe: 0 to 24 hours post-dosePopulation: Pharmacokinetic analysis set: All randomized patients with evaluable pharmacokinetic data, ie, from which at least one pharmacokinetic parameter could be determined and sampling time information was available, from at least one treatment period.
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.
Outcome measures
| Measure |
Indacaterol 150 μg
n=15 Participants
Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI) only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 60 μg
n=14 Participants
Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 120 μg
n=14 Participants
Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Placebo to Indacaterol
Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Indacaterol Exposure (AUC[0-24 Hours]) for Each Treatment
|
1119.2 pg*hr/mL
Standard Deviation 379.1
|
435.8 pg*hr/mL
Standard Deviation 245.7
|
849.4 pg*hr/mL
Standard Deviation 272.7
|
—
|
SECONDARY outcome
Timeframe: 0 to 24 hours post-dosePopulation: Pharmacokinetic analysis set: All randomized patients with evaluable pharmacokinetic data, ie, from which at least one pharmacokinetic parameter could be determined and sampling time information was available, from at least one treatment period.
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.
Outcome measures
| Measure |
Indacaterol 150 μg
n=15 Participants
Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI) only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 60 μg
n=14 Participants
Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 120 μg
n=14 Participants
Patients received Indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Placebo to Indacaterol
Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Indacaterol Exposure (Cmax) for Each Treatment
|
150.5 pg/mL
Standard Deviation 30.4
|
95.2 pg/mL
Standard Deviation 57.3
|
141.7 pg/mL
Standard Deviation 55.0
|
—
|
Adverse Events
Indacaterol 150 μg
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Indacaterol 60 μg
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Indacaterol 120 μg
Serious events: 0 serious events
Other events: 21 other events
Deaths: 0 deaths
Placebo to Indacaterol
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Indacaterol 150 μg
n=33 participants at risk
Patients received indacaterol 150 μg via the Concept1 dry-powder inhaler (DPI)only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 60 μg
n=33 participants at risk
Patients received Indacaterol 60 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Indacaterol 120 μg
n=34 participants at risk
Patients received indacaterol 120 μg via the Simoon dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
Placebo to Indacaterol
n=35 participants at risk
Patients received placebo to indacaterol via the Concept1 dry-powder inhaler only once. There was a washout period of 14-17 days between treatments for patients undergoing pharmacokinetic (PK) assessments; for patients not undergoing PK assessments, the washout period was 7-10 days. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol was available for rescue use throughout the study.
|
|---|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/33
Safety population included all randomized patients that received at least one dose of study drug.
|
0.00%
0/33
Safety population included all randomized patients that received at least one dose of study drug.
|
2.9%
1/34
Safety population included all randomized patients that received at least one dose of study drug.
|
5.7%
2/35
Safety population included all randomized patients that received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
15.2%
5/33
Safety population included all randomized patients that received at least one dose of study drug.
|
12.1%
4/33
Safety population included all randomized patients that received at least one dose of study drug.
|
8.8%
3/34
Safety population included all randomized patients that received at least one dose of study drug.
|
8.6%
3/35
Safety population included all randomized patients that received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
48.5%
16/33
Safety population included all randomized patients that received at least one dose of study drug.
|
45.5%
15/33
Safety population included all randomized patients that received at least one dose of study drug.
|
55.9%
19/34
Safety population included all randomized patients that received at least one dose of study drug.
|
17.1%
6/35
Safety population included all randomized patients that received at least one dose of study drug.
|
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