Asthma
Conditions
Keywords
Asthma, QMF149, fixed combination of indacaterol and mometasone furoate
Brief summary
This study is designed to evaluate the bronchodilatory efficacy of indacaterol maleate 500 μg/mometasone furoate 400 μg via the Twisthaler® device in adult patients with persistent asthma.
Interventions
DRUGindacaterol maleate/mometasone furoate
Indacaterol maleate 250 μg / mometasone furoate 200 μg delivered via the Twisthaler device.
Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.
DRUGfluticasone proprionate / salmeterol xinafoate
Fluticasone proprionate 250 μg / salmeterol xinafoate 50 μg delivered via the Accuhaler® device.
Sponsors
Merck Sharp & Dohme LLC
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Male and female adult patients aged 18-75 years with persistent asthma * Patients with persistent asthma, diagnosed according to the Global Initiative for Asthma guidelines (GINA) and who additionally met the following criteria: 1. Patients receiving daily treatment with inhaled corticosteroid up to the maximum dose per day indicated in the package leaflet, in a stable regimen for the month prior to Visit 1. 2. Patients with a forced expiratory volume in 1 second (FEV1) at Visit 1 of ≥ 50% of the predicted normal value. This criterion for FEV1 had to be demonstrated after a washout period of at least 6 hours during which no short acting β2-agonist had been inhaled, and a minimum of 48 hours for a long acting β2-agonist. 3. Patients who demonstrated an increase of ≥12% and ≥200 mL in FEV1 over their pre-bronchodilator value 30 minutes after inhaling a total of 200 μg of salbutamol (or albuterol) via metered dose inhaler (MDI) (the reversibility test). Reversibility had to be demonstrated after an appropriate washout period of at least 6 hrs prior to the evaluation for a shortacting β2-agonist. The administration of salbutamol (or albuterol) for the reversibility test was to be within 30 minutes after pre-bronchodilator spirometry. Reversibility had to be demonstrated at Visit 1 or between Visits 1 and 2, in order for patients to be included in the trial. 4. For each patient, the smaller value of the Visit 1 FEV1 or the Visit 2 FEV1 pre-dose value had to be at least 85% of the larger value. * Body mass index (BMI) between 18 and 32 kg/m\^2 and weight \>50 kg. * patients using local contraception
Exclusion criteria
* Pregnant or nursing women * Recent use of tobacco or history of smoking \> 10 pack years * Patients diagnosed with chronic obstructive pulmonary disease (COPD) * Patients with recent experience of severe asthma attack/exacerbation within 6-months of study start * Patients with frequent rescue medication (\>8 puffs/day for two consecutive days) * Clinically relevant laboratory abnormality or a clinically significant condition * Active cancer or a history of cancer with less than 5 years disease free survival time * History of long QT syndrome or with long QTc interval prior to dosing * History of hypersensitivity to the study drugs or to drugs with similar chemical structures * Use of certain medications * Use of other investigational drugs * A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result * History of immunodeficiency diseases, including a positive human immumodeficiency virus (HIV) test result. * History of drug or alcohol abuse or evidence of such abuse Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) | Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16). | FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from the period baseline to 24 hour post dose trough FEV1 after 1 day of treatment was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to Reach Peak or Maximum Concentration Following Drug Administration for Mometasone Furoate | Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose. | — |
| Time to Reach Peak or Maximum Concentration Following Drug Administration for Indacaterol | Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose. | — |
| Change From Period Baseline in Trough Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) | Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16). | Trough FEV1 was measured 24 hours post-dose. The FEV1 percent predicted expresses FEV1 as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. Change from baseline in trough FEV1 % predicted was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate. |
| Change From Period Baseline in Peak Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) | Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose. | Peak FEV1 was defined as the peak FEV1 up to 4 hours post-dose. The FEV1 percent predicted expresses FEV1 as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. Change from baseline in peak FEV1 % predicted was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate. |
| Change From Period Baseline in Trough Forced Vital Capacity (FVC) | Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16). | Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was measured 24 hours post-dose. Change form baseline in trough FVC was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate. |
| Change From Period Baseline in Peak Forced Vital Capacity (FVC) | Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose. | Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Peak FVC was measured up to 4 hours post-dose. Change from baseline in peak FVC was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate. |
| Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) | Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose. | FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Peak FEV1 is defined as the peak FEV1 between 0 and 4 hours post-dose. The change from baseline in peak FEV1 was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate. |
| Change From Period Baseline in Peak FEV1/FVC Ratio | Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose. | The forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio represents the proportion of a person's vital capacity that they are able to expire in the first second of an expiration. Peak FEV1/FVC was calculated from spirometry measurements taken up to 4 hours post-dose. Change from baseline in peak FEV1/FVC ratio was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate. |
| Area Under the Concentration-time Curve From Time 0 to 12 Hours Post-dose for Mometasone Furoate | Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, and 12 hours post-dose. | — |
| Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Mometasone Furoate | Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose. | — |
| Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Indacaterol | Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose. | — |
| Maximum (Peak) Plasma Concentration (Cmax) of Mometasone Furoate | Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose. | — |
| Maximum (Peak) Plasma Concentration (Cmax) of Indacaterol | Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose. | — |
| Change From Period Baseline in Trough FEV1/FVC Ratio | Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16). | The forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio represents the proportion of a person's vital capacity that they are able to expire in the first second of an expiration. Trough FEV1/FVC was calculated from measurements taken 24 hours post-dose. Change from baseline in trough FEV1/FVC ratio was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate. |
Countries
France, Germany
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Indacaterol/Mometasone - Placebo In Treatment Period 1 (Day 1) participants received 2 inhalations of indacaterol maleate 250 μg/mometasone furoate 200 μg once a day in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of placebo via the Twisthaler device once a day in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg/salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days. | 16 |
| Placebo - Indacaterol/Mometasone In Treatment Period 1 (Day 1) participants received 2 inhalations of placebo in the morning via the Twisthaler device. In Treatment Period 2 (Day 8) participants received 2 inhalations of indacaterol maleate 250 μg/mometasone furoate 200 μg via the Twisthaler device in the morning. In Treatment Period 3 (Day 15) participants received fluticasone proprionate 250 μg/salmeterol xinafoate 50 μg twice a day delivered via dry-powder inhaler. Each treatment period was separated by a minimum washout period of 7 days. | 15 |
| Total | 31 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol deviation | 3 | 2 |
Baseline characteristics
| Characteristic | Indacaterol/Mometasone - Placebo | Placebo - Indacaterol/Mometasone | Total |
|---|---|---|---|
| Age Continuous | 39.1 years STANDARD_DEVIATION 11.93 | 41.5 years STANDARD_DEVIATION 7.23 | 40.3 years STANDARD_DEVIATION 9.85 |
| Sex: Female, Male Female | 9 Participants | 6 Participants | 15 Participants |
| Sex: Female, Male Male | 7 Participants | 9 Participants | 16 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 10 / 29 | 6 / 28 | 2 / 26 |
| serious Total, serious adverse events | 0 / 29 | 0 / 28 | 0 / 26 |
Outcome results
Primary
Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1)
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Change from the period baseline to 24 hour post dose trough FEV1 after 1 day of treatment was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate.
Time frame: Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).
Population: Pharmacodynamic population included all patients randomized that received at least one dose of study drug and completed the first two treatment periods with evaluable data for the primary efficacy variable, and with no major protocol deviations. 7 patients who were inadvertently unblinded by the investigator were excluded from the PD analysis.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Indacaterol/Mometasone | Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) | 0.27 liters |
| Placebo | Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) | -0.12 liters |
| Fluticasone/Salmeterol | Change From Period Baseline to 24 Hour Post-dose (Trough) Forced Expiratory Volume in 1 Second (FEV1) | 0.37 liters |
Comparison: The primary hypothesis tested was that the change from period baseline of trough FEV1 for placebo and indacaterol/mometasone was equal. The one-sided alternative was that the increase from period baseline of trough FEV1 for indacaterol/mometasone was higher than for placebo.p-value: <0.000190% CI: [0.28, 0.51]1-sided
Secondary
Area Under the Concentration-time Curve From Time 0 to 12 Hours Post-dose for Mometasone Furoate
Time frame: Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, and 12 hours post-dose.
Population: All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Indacaterol/Mometasone | Area Under the Concentration-time Curve From Time 0 to 12 Hours Post-dose for Mometasone Furoate | 287 pg*h/mL | Standard Deviation 140 |
Secondary
Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Indacaterol
Time frame: Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.
Population: All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Indacaterol/Mometasone | Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Indacaterol | 1331 pg*h/mL | Standard Deviation 712 |
Secondary
Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Mometasone Furoate
Time frame: Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.
Population: All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Indacaterol/Mometasone | Area Under the Concentration-time Curve From Time 0 to 24 Hours Post-dose for Mometasone Furoate | 389 pg*h/mL | Standard Deviation 191 |
Secondary
Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1)
FEV1 is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. Peak FEV1 is defined as the peak FEV1 between 0 and 4 hours post-dose. The change from baseline in peak FEV1 was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose FEV1 as covariate.
Time frame: Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.
Population: Pharmacodynamic population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Indacaterol/Mometasone | Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) | 0.64 liters |
| Placebo | Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) | 0.26 liters |
| Fluticasone/Salmeterol | Change From Baseline in Peak Forced Expiratory Volume in One Second (FEV1) | 0.62 liters |
Secondary
Change From Period Baseline in Peak FEV1/FVC Ratio
The forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio represents the proportion of a person's vital capacity that they are able to expire in the first second of an expiration. Peak FEV1/FVC was calculated from spirometry measurements taken up to 4 hours post-dose. Change from baseline in peak FEV1/FVC ratio was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.
Time frame: Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.
Population: Pharmacodynamic population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Indacaterol/Mometasone | Change From Period Baseline in Peak FEV1/FVC Ratio | 2.86 ratio |
| Placebo | Change From Period Baseline in Peak FEV1/FVC Ratio | 2.53 ratio |
| Fluticasone/Salmeterol | Change From Period Baseline in Peak FEV1/FVC Ratio | 2.90 ratio |
Secondary
Change From Period Baseline in Peak Forced Vital Capacity (FVC)
Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Peak FVC was measured up to 4 hours post-dose. Change from baseline in peak FVC was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.
Time frame: Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.
Population: Pharmacodynamic population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Indacaterol/Mometasone | Change From Period Baseline in Peak Forced Vital Capacity (FVC) | 0.47 liters |
| Placebo | Change From Period Baseline in Peak Forced Vital Capacity (FVC) | 0.20 liters |
| Fluticasone/Salmeterol | Change From Period Baseline in Peak Forced Vital Capacity (FVC) | 0.35 liters |
Secondary
Change From Period Baseline in Peak Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)
Peak FEV1 was defined as the peak FEV1 up to 4 hours post-dose. The FEV1 percent predicted expresses FEV1 as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. Change from baseline in peak FEV1 % predicted was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.
Time frame: Days 1, 8 and 15, pre-dose (Baseline) and 5, 15, and 30 minutes, 1, 2, 3, and 4 hours post-dose.
Population: Pharmacodynamic population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Indacaterol/Mometasone | Change From Period Baseline in Peak Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) | 16.27 Percent of predicted |
| Placebo | Change From Period Baseline in Peak Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) | 6.85 Percent of predicted |
| Fluticasone/Salmeterol | Change From Period Baseline in Peak Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) | 16.49 Percent of predicted |
Secondary
Change From Period Baseline in Trough FEV1/FVC Ratio
The forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ratio represents the proportion of a person's vital capacity that they are able to expire in the first second of an expiration. Trough FEV1/FVC was calculated from measurements taken 24 hours post-dose. Change from baseline in trough FEV1/FVC ratio was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.
Time frame: Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).
Population: Pharmacodynamic population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Indacaterol/Mometasone | Change From Period Baseline in Trough FEV1/FVC Ratio | 2.50 ratio |
| Placebo | Change From Period Baseline in Trough FEV1/FVC Ratio | 2.15 ratio |
| Fluticasone/Salmeterol | Change From Period Baseline in Trough FEV1/FVC Ratio | 2.65 ratio |
Secondary
Change From Period Baseline in Trough Forced Vital Capacity (FVC)
Vital capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Trough FVC was measured 24 hours post-dose. Change form baseline in trough FVC was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.
Time frame: Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).
Population: Pharmacodynamic population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Indacaterol/Mometasone | Change From Period Baseline in Trough Forced Vital Capacity (FVC) | 0.22 liters |
| Placebo | Change From Period Baseline in Trough Forced Vital Capacity (FVC) | -0.14 liters |
| Fluticasone/Salmeterol | Change From Period Baseline in Trough Forced Vital Capacity (FVC) | 0.17 liters |
Secondary
Change From Period Baseline in Trough Percent Predicted Forced Expiratory Volume in 1 Second (FEV1)
Trough FEV1 was measured 24 hours post-dose. The FEV1 percent predicted expresses FEV1 as a percentage of the predicted values for participants of similar characteristics (height, age, sex, and sometimes race and weight). A positive change from baseline in FEV1 % predicted indicates improvement in lung function. Change from baseline in trough FEV1 % predicted was modeled using a linear mixed effect model fitting treatment, sequence and period as fixed factors, patient within sequence as a random factor and pre-dose value as covariate.
Time frame: Pre-dose for each Treatment Period (Days 1, 8 and 15) and 24-hours post-dose for each Treatment Period (Days 2, 9 and 16).
Population: Pharmacodynamic population
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Indacaterol/Mometasone | Change From Period Baseline in Trough Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) | 6.95 Percent of predicted |
| Placebo | Change From Period Baseline in Trough Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) | -2.87 Percent of predicted |
| Fluticasone/Salmeterol | Change From Period Baseline in Trough Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) | 9.85 Percent of predicted |
Secondary
Maximum (Peak) Plasma Concentration (Cmax) of Indacaterol
Time frame: Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.
Population: All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Indacaterol/Mometasone | Maximum (Peak) Plasma Concentration (Cmax) of Indacaterol | 289 pg/mL | Standard Deviation 133 |
Secondary
Maximum (Peak) Plasma Concentration (Cmax) of Mometasone Furoate
Time frame: Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.
Population: All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Indacaterol/Mometasone | Maximum (Peak) Plasma Concentration (Cmax) of Mometasone Furoate | 47.3 pg/mL | Standard Deviation 20.9 |
Secondary
Time to Reach Peak or Maximum Concentration Following Drug Administration for Indacaterol
Time frame: Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.
Population: All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Indacaterol/Mometasone | Time to Reach Peak or Maximum Concentration Following Drug Administration for Indacaterol | 0.325 hours |
Secondary
Time to Reach Peak or Maximum Concentration Following Drug Administration for Mometasone Furoate
Time frame: Samples were taken pre-dose and at 15 and 30 minutes and 1, 2, 4, 12 and 24 hours post-dose.
Population: All participants with evaluable pharmacokinetic (PK) parameter data were included in the PK data analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Indacaterol/Mometasone | Time to Reach Peak or Maximum Concentration Following Drug Administration for Mometasone Furoate | 1.05 hours |