Asthma
Conditions
Keywords
Asthma, spirometry, lung function, serum cortisol, serum potassium, plasma glucose
Brief summary
This study will investigate the safety and tolerability of indacaterol maleate/mometasone furoate via the Twisthaler device after 14 days treatment in patients with mild to moderate asthma.
Interventions
Indacaterol maleate / mometasone furoate 250/400 μg, 2 puffs once daily delivered via the Twisthaler device.
Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.
Sponsors
Merck Sharp & Dohme LLC
Novartis
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male and female adult patients aged 18-65 years (inclusive) * Patients with mild-moderate asthma * Forced expiratory volume in one second (FEV1) at Visits 1 and 2 are ≥60% of the predicted normal value for the patient. * Body mass index (BMI) must be within the range of 18-32 kg/m\^2. * Non-smokers or light smokers (≤10 cigarettes per day), with a smoking history of 10 pack years or less.
Exclusion criteria
* Patients who suffer from chronic obstructive pulmonary disease (COPD) * Patients who have been hospitalized or had emergency treatment for an asthma attack in the 6 months prior to study start * QTcF interval \> 450 msec in men and \>470 msec in women * Pregnant women or nursing mothers * Females of childbearing potential, regardless of whether or not sexually active, if they are not using a reliable form of contraception (surgical contraception or double barrier methods (to be continued for at least two months following last dose) are acceptable). * History of immunocompromise, including a positive human immunodeficiency virus (HIV) * A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result. * History of drug or alcohol abuse within 12 months of dosing Other protocol-defined inclusion/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants With Adverse Events | 15 days | An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Abnormal laboratory values or test results constitute adverse events only if they induce clinical signs or symptoms, are considered clinically significant, or require intervention. A serious adverse event (SAE) is defined as an event which is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization, or is medically significant, i.e., defined as an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Levels of Serum Potassium Over Time | Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4 hours post-dose; 12 and 24 hours post-dose (Day 2); study completion (5-9 days after last dose, Day 19-23). | At the specified time-points, blood samples were collected for measurement of serum potassium and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose. |
| Levels of Plasma Glucose Over Time | Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4 hours post-dose; 12 and 24 hours post dose (Day 2); study completion (5-9 days after last dose, Day 19-23). | At the specified time-points, blood samples were collected for measurement of plasma glucose and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose. |
| Levels of Serum Cortisol Over Time | Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4, 11, 12, 13 hours post-dose; 24 hours post dose (Day 2); study completion (5-9 days after last dose, Day 19-23). | At the specified time-points, blood samples were collected for measurement of serum cortisol and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose. |
Countries
France
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Indacaterol Maleate/Mometasone Furoate Participants received 2 inhalations of indacaterol maleate / mometasone furoate 250/400 μg once daily in the evening (full dose 500/800 μg) delivered via the Twisthaler device for 14 days. | 14 |
| Placebo Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days. | 14 |
| Total | 28 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 |
Baseline characteristics
| Characteristic | Indacaterol Maleate/Mometasone Furoate | Placebo | Total |
|---|---|---|---|
| Age Continuous | 31.0 years STANDARD_DEVIATION 7.18 | 33.9 years STANDARD_DEVIATION 13.35 | 32.4 years STANDARD_DEVIATION 10.62 |
| Sex: Female, Male Female | 7 Participants | 6 Participants | 13 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 9 / 14 | 12 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
Participants With Adverse Events
An adverse event (AE) is the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after starting the study drug even if the event is not considered to be related to study drug. Abnormal laboratory values or test results constitute adverse events only if they induce clinical signs or symptoms, are considered clinically significant, or require intervention. A serious adverse event (SAE) is defined as an event which is fatal or life-threatening, results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, requires inpatient hospitalization or prolongation of existing hospitalization, or is medically significant, i.e., defined as an event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: 15 days
Population: All participants
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Indacaterol Maleate/Mometasone Furoate | Participants With Adverse Events | Any adverse event | 9 participants |
| Indacaterol Maleate/Mometasone Furoate | Participants With Adverse Events | Serious adverse event | 0 participants |
| Indacaterol Maleate/Mometasone Furoate | Participants With Adverse Events | AE resulting in discontinuation | 0 participants |
| Placebo | Participants With Adverse Events | Any adverse event | 12 participants |
| Placebo | Participants With Adverse Events | Serious adverse event | 0 participants |
| Placebo | Participants With Adverse Events | AE resulting in discontinuation | 1 participants |
Secondary
Levels of Plasma Glucose Over Time
At the specified time-points, blood samples were collected for measurement of plasma glucose and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose.
Time frame: Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4 hours post-dose; 12 and 24 hours post dose (Day 2); study completion (5-9 days after last dose, Day 19-23).
Population: All participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Indacaterol Maleate/Mometasone Furoate | Levels of Plasma Glucose Over Time | Baseline (N=14, 14) | 5.079 mmol/L | Standard Deviation 0.3239 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Plasma Glucose Over Time | Day 1, pre-dose (N=14, 14) | 5.057 mmol/L | Standard Deviation 0.2533 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Plasma Glucose Over Time | Day 1, 0.25 hours post-dose (N=14, 14) | 5.007 mmol/L | Standard Deviation 0.2786 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Plasma Glucose Over Time | Day 1, 0.5 hours post-dose (N=14, 14) | 4.950 mmol/L | Standard Deviation 0.2279 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Plasma Glucose Over Time | Day 1, 1 hour post-dose (N=14, 14) | 5.036 mmol/L | Standard Deviation 0.262 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Plasma Glucose Over Time | Day 1, 2 hours post-dose (N=14, 14) | 5.057 mmol/L | Standard Deviation 0.2377 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Plasma Glucose Over Time | Day 1, 4 hours post-dose (N=14, 14) | 7.064 mmol/L | Standard Deviation 1.4532 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Plasma Glucose Over Time | Day 2, 12 hours post-dose (N=14, 14) | 5.221 mmol/L | Standard Deviation 0.2326 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Plasma Glucose Over Time | Day 2, 24 hours post-dose (N=14, 14) | 5.293 mmol/L | Standard Deviation 0.4463 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Plasma Glucose Over Time | Day 14, pre-dose (N=14, 14) | 5.129 mmol/L | Standard Deviation 0.4681 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Plasma Glucose Over Time | Day 14, 0.25 hours post-dose (N=14, 13) | 5.136 mmol/L | Standard Deviation 0.4986 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Plasma Glucose Over Time | Day 14, 0.5 hours post-dose (N=14, 13) | 5.157 mmol/L | Standard Deviation 0.4767 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Plasma Glucose Over Time | Day 14, 1 hour post-dose (N=14, 13) | 5.136 mmol/L | Standard Deviation 0.4448 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Plasma Glucose Over Time | Day 14, 2 hours post-dose (N=14, 13) | 5.093 mmol/L | Standard Deviation 0.3269 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Plasma Glucose Over Time | Day 14, 4 hours post-dose (N=14, 13) | 6.929 mmol/L | Standard Deviation 1.3176 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Plasma Glucose Over Time | End of study (N=14, 13) | 5.257 mmol/L | Standard Deviation 0.2821 |
| Placebo | Levels of Plasma Glucose Over Time | End of study (N=14, 13) | 5.731 mmol/L | Standard Deviation 1.016 |
| Placebo | Levels of Plasma Glucose Over Time | Baseline (N=14, 14) | 5.157 mmol/L | Standard Deviation 0.4415 |
| Placebo | Levels of Plasma Glucose Over Time | Day 2, 24 hours post-dose (N=14, 14) | 5.321 mmol/L | Standard Deviation 0.5767 |
| Placebo | Levels of Plasma Glucose Over Time | Day 1, pre-dose (N=14, 14) | 5.236 mmol/L | Standard Deviation 0.3855 |
| Placebo | Levels of Plasma Glucose Over Time | Day 14, 1 hour post-dose (N=14, 13) | 4.962 mmol/L | Standard Deviation 0.3841 |
| Placebo | Levels of Plasma Glucose Over Time | Day 1, 0.25 hours post-dose (N=14, 14) | 5.264 mmol/L | Standard Deviation 0.4069 |
| Placebo | Levels of Plasma Glucose Over Time | Day 14, pre-dose (N=14, 14) | 5.221 mmol/L | Standard Deviation 0.3534 |
| Placebo | Levels of Plasma Glucose Over Time | Day 1, 0.5 hours post-dose (N=14, 14) | 5.207 mmol/L | Standard Deviation 0.3385 |
| Placebo | Levels of Plasma Glucose Over Time | Day 14, 4 hours post-dose (N=14, 13) | 7.408 mmol/L | Standard Deviation 1.0649 |
| Placebo | Levels of Plasma Glucose Over Time | Day 1, 1 hour post-dose (N=14, 14) | 5.193 mmol/L | Standard Deviation 0.3316 |
| Placebo | Levels of Plasma Glucose Over Time | Day 14, 0.25 hours post-dose (N=14, 13) | 4.900 mmol/L | Standard Deviation 0.4301 |
| Placebo | Levels of Plasma Glucose Over Time | Day 1, 2 hours post-dose (N=14, 14) | 5.179 mmol/L | Standard Deviation 0.3142 |
| Placebo | Levels of Plasma Glucose Over Time | Day 14, 2 hours post-dose (N=14, 13) | 4.908 mmol/L | Standard Deviation 0.4173 |
| Placebo | Levels of Plasma Glucose Over Time | Day 1, 4 hours post-dose (N=14, 14) | 6.793 mmol/L | Standard Deviation 1.2344 |
| Placebo | Levels of Plasma Glucose Over Time | Day 14, 0.5 hours post-dose (N=14, 13) | 4.946 mmol/L | Standard Deviation 0.4409 |
| Placebo | Levels of Plasma Glucose Over Time | Day 2, 12 hours post-dose (N=14, 14) | 5.286 mmol/L | Standard Deviation 0.3009 |
Secondary
Levels of Serum Cortisol Over Time
At the specified time-points, blood samples were collected for measurement of serum cortisol and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose.
Time frame: Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4, 11, 12, 13 hours post-dose; 24 hours post dose (Day 2); study completion (5-9 days after last dose, Day 19-23).
Population: All participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Cortisol Over Time | Day 1, pre-dose (N=14, 14) | 159.643 mmol/L | Standard Deviation 100.4533 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Cortisol Over Time | Day 2, 24 hours post-dose (N=14, 14) | 136.857 mmol/L | Standard Deviation 75.4442 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Cortisol Over Time | Day 1, 1 hour post-dose (N=14, 14) | 99.143 mmol/L | Standard Deviation 54.5412 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Cortisol Over Time | Day 14, pre-dose (N=14, 14) | 126.071 mmol/L | Standard Deviation 65.6546 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Cortisol Over Time | Baseline (N=14, 14) | 466.214 mmol/L | Standard Deviation 178.2311 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Cortisol Over Time | Day 14, 0.25 hours post-dose (N=14, 13) | 111.500 mmol/L | Standard Deviation 82.9001 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Cortisol Over Time | Day 1, 2 hours post-dose (N=14, 14) | 65.357 mmol/L | Standard Deviation 33.1143 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Cortisol Over Time | Day 14, 0.5 hours post-dose (N=14, 13) | 99.500 mmol/L | Standard Deviation 68.5608 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Cortisol Over Time | Day 1, 0.25 hours post-dose (N=14, 14) | 153.786 mmol/L | Standard Deviation 87.5313 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Cortisol Over Time | Day 14, 1 hour post-dose (N=14, 13) | 82.786 mmol/L | Standard Deviation 57.7663 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Cortisol Over Time | Day 1, 4 hours post-dose (N=14, 14) | 55.929 mmol/L | Standard Deviation 24.6716 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Cortisol Over Time | Day 14, 2 hours post-dose (N=14, 13) | 62.071 mmol/L | Standard Deviation 44.5861 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Cortisol Over Time | Day 15, 12 hours post-dose (N=14, 13) | 255.500 mmol/L | Standard Deviation 154.1442 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Cortisol Over Time | Day 14, 4 hours post-dose (N=14, 13) | 48.214 mmol/L | Standard Deviation 34.528 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Cortisol Over Time | Day 2, 11 hours post-dose (N=14, 14) | 362.500 mmol/L | Standard Deviation 159.3891 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Cortisol Over Time | Day 15, 11 hours post-dose (N=14, 14) | 242.143 mmol/L | Standard Deviation 177.3739 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Cortisol Over Time | Day 2, 12 hours post-dose (N=14, 14) | 289.929 mmol/L | Standard Deviation 96.3906 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Cortisol Over Time | Day 15, 13 hours post-dose (N=14, 13) | 324.857 mmol/L | Standard Deviation 179.8713 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Cortisol Over Time | Day 1, 0.5 hours post-dose (N=14, 14) | 130.143 mmol/L | Standard Deviation 74.2375 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Cortisol Over Time | End of study (N=14, 14) | 495.286 mmol/L | Standard Deviation 259.2054 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Cortisol Over Time | Day 2, 13 hours post-dose (N=14, 14) | 335.214 mmol/L | Standard Deviation 150.7811 |
| Placebo | Levels of Serum Cortisol Over Time | End of study (N=14, 14) | 417.786 mmol/L | Standard Deviation 164.1046 |
| Placebo | Levels of Serum Cortisol Over Time | Day 15, 11 hours post-dose (N=14, 14) | 417.000 mmol/L | Standard Deviation 100.8312 |
| Placebo | Levels of Serum Cortisol Over Time | Baseline (N=14, 14) | 441.143 mmol/L | Standard Deviation 97.5365 |
| Placebo | Levels of Serum Cortisol Over Time | Day 1, pre-dose (N=14, 14) | 140.714 mmol/L | Standard Deviation 47.2024 |
| Placebo | Levels of Serum Cortisol Over Time | Day 1, 0.25 hours post-dose (N=14, 14) | 151.000 mmol/L | Standard Deviation 91.2798 |
| Placebo | Levels of Serum Cortisol Over Time | Day 1, 0.5 hours post-dose (N=14, 14) | 130.571 mmol/L | Standard Deviation 63.6779 |
| Placebo | Levels of Serum Cortisol Over Time | Day 1, 1 hour post-dose (N=14, 14) | 131.929 mmol/L | Standard Deviation 51.4923 |
| Placebo | Levels of Serum Cortisol Over Time | Day 1, 2 hours post-dose (N=14, 14) | 84.286 mmol/L | Standard Deviation 27.122 |
| Placebo | Levels of Serum Cortisol Over Time | Day 1, 4 hours post-dose (N=14, 14) | 102.071 mmol/L | Standard Deviation 54.8248 |
| Placebo | Levels of Serum Cortisol Over Time | Day 2, 12 hours post-dose (N=14, 14) | 404.214 mmol/L | Standard Deviation 123.4623 |
| Placebo | Levels of Serum Cortisol Over Time | Day 2, 13 hours post-dose (N=14, 14) | 370.071 mmol/L | Standard Deviation 105.2451 |
| Placebo | Levels of Serum Cortisol Over Time | Day 2, 24 hours post-dose (N=14, 14) | 193.500 mmol/L | Standard Deviation 87.5238 |
| Placebo | Levels of Serum Cortisol Over Time | Day 14, pre-dose (N=14, 14) | 122.857 mmol/L | Standard Deviation 71.5379 |
| Placebo | Levels of Serum Cortisol Over Time | Day 14, 0.25 hours post-dose (N=14, 13) | 127.231 mmol/L | Standard Deviation 104.5834 |
| Placebo | Levels of Serum Cortisol Over Time | Day 14, 0.5 hours post-dose (N=14, 13) | 121.154 mmol/L | Standard Deviation 112.2726 |
| Placebo | Levels of Serum Cortisol Over Time | Day 14, 1 hour post-dose (N=14, 13) | 106.385 mmol/L | Standard Deviation 118.7936 |
| Placebo | Levels of Serum Cortisol Over Time | Day 14, 2 hours post-dose (N=14, 13) | 94.154 mmol/L | Standard Deviation 133.83 |
| Placebo | Levels of Serum Cortisol Over Time | Day 14, 4 hours post-dose (N=14, 13) | 102.154 mmol/L | Standard Deviation 80.7051 |
| Placebo | Levels of Serum Cortisol Over Time | Day 15, 12 hours post-dose (N=14, 13) | 388.769 mmol/L | Standard Deviation 104.6885 |
| Placebo | Levels of Serum Cortisol Over Time | Day 15, 13 hours post-dose (N=14, 13) | 385.769 mmol/L | Standard Deviation 126.2301 |
| Placebo | Levels of Serum Cortisol Over Time | Day 2, 11 hours post-dose (N=14, 14) | 478.214 mmol/L | Standard Deviation 121.2272 |
Secondary
Levels of Serum Potassium Over Time
At the specified time-points, blood samples were collected for measurement of serum potassium and the samples analyzed by a central laboratory. The end of study visit was conducted approximately 5-9 days after the last dose.
Time frame: Baseline; Days 1 and 14 at pre-dose, 0.25, 0.5, 1, 2, 4 hours post-dose; 12 and 24 hours post-dose (Day 2); study completion (5-9 days after last dose, Day 19-23).
Population: All participants
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Potassium Over Time | Baseline (N=14, 14) | 4.271 mmol/L | Standard Deviation 0.2867 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Potassium Over Time | Day 1, pre-dose (N=14, 14) | 4.264 mmol/L | Standard Deviation 0.224 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Potassium Over Time | Day 1, 0.25 hours post-dose (N=14, 14) | 4.293 mmol/L | Standard Deviation 0.3583 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Potassium Over Time | Day 1, 0.5 hours post-dose (N=14, 14) | 4.150 mmol/L | Standard Deviation 0.2442 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Potassium Over Time | Day 1, 1 hour post-dose (N=14, 14) | 4.143 mmol/L | Standard Deviation 0.2174 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Potassium Over Time | Day 1, 2 hours post-dose (N=14, 14) | 4.157 mmol/L | Standard Deviation 0.2709 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Potassium Over Time | Day 1, 4 hours post-dose (N=14, 14) | 3.979 mmol/L | Standard Deviation 0.2486 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Potassium Over Time | Day 2, 12 hours post-dose (N=14, 14) | 4.436 mmol/L | Standard Deviation 0.253 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Potassium Over Time | Day 2, 24 hours post-dose (N=14, 14) | 4.293 mmol/L | Standard Deviation 0.2786 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Potassium Over Time | Day 14, pre-dose (N=14, 14) | 4.150 mmol/L | Standard Deviation 0.3205 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Potassium Over Time | Day 14, 0.25 hours post-dose (N=14, 13) | 4.064 mmol/L | Standard Deviation 0.3522 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Potassium Over Time | Day 14, 0.5 hours post-dose (N=14, 13) | 3.986 mmol/L | Standard Deviation 0.3325 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Potassium Over Time | Day 14, 1 hour post-dose (N=14, 13) | 3.986 mmol/L | Standard Deviation 0.388 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Potassium Over Time | Day 14, 2 hours post-dose (N=14, 13) | 3.986 mmol/L | Standard Deviation 0.2627 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Potassium Over Time | Day 14, 4 hours post-dose (N=14, 13) | 3.800 mmol/L | Standard Deviation 0.3397 |
| Indacaterol Maleate/Mometasone Furoate | Levels of Serum Potassium Over Time | End of study (N=14, 14) | 4.364 mmol/L | Standard Deviation 0.2373 |
| Placebo | Levels of Serum Potassium Over Time | End of study (N=14, 14) | 4.429 mmol/L | Standard Deviation 0.4103 |
| Placebo | Levels of Serum Potassium Over Time | Baseline (N=14, 14) | 4.336 mmol/L | Standard Deviation 0.3388 |
| Placebo | Levels of Serum Potassium Over Time | Day 2, 24 hours post-dose (N=14, 14) | 4.386 mmol/L | Standard Deviation 0.4753 |
| Placebo | Levels of Serum Potassium Over Time | Day 1, pre-dose (N=14, 14) | 4.279 mmol/L | Standard Deviation 0.3446 |
| Placebo | Levels of Serum Potassium Over Time | Day 14, 1 hour post-dose (N=14, 13) | 4.038 mmol/L | Standard Deviation 0.4426 |
| Placebo | Levels of Serum Potassium Over Time | Day 1, 0.25 hours post-dose (N=14, 14) | 4.314 mmol/L | Standard Deviation 0.5803 |
| Placebo | Levels of Serum Potassium Over Time | Day 14, pre-dose (N=14, 14) | 4.136 mmol/L | Standard Deviation 0.3079 |
| Placebo | Levels of Serum Potassium Over Time | Day 1, 0.5 hours post-dose (N=14, 14) | 4.179 mmol/L | Standard Deviation 0.3093 |
| Placebo | Levels of Serum Potassium Over Time | Day 14, 4 hours post-dose (N=14, 13) | 3.792 mmol/L | Standard Deviation 0.2397 |
| Placebo | Levels of Serum Potassium Over Time | Day 1, 1 hour post-dose (N=14, 14) | 4.171 mmol/L | Standard Deviation 0.2614 |
| Placebo | Levels of Serum Potassium Over Time | Day 14, 0.25 hours post-dose (N=14, 13) | 4.092 mmol/L | Standard Deviation 0.3353 |
| Placebo | Levels of Serum Potassium Over Time | Day 1, 2 hours post-dose (N=14, 14) | 4.093 mmol/L | Standard Deviation 0.22 |
| Placebo | Levels of Serum Potassium Over Time | Day 14, 2 hours post-dose (N=14, 13) | 4.038 mmol/L | Standard Deviation 0.3927 |
| Placebo | Levels of Serum Potassium Over Time | Day 1, 4 hours post-dose (N=14, 14) | 3.929 mmol/L | Standard Deviation 0.2494 |
| Placebo | Levels of Serum Potassium Over Time | Day 14, 0.5 hours post-dose (N=14, 13) | 4.092 mmol/L | Standard Deviation 0.3378 |
| Placebo | Levels of Serum Potassium Over Time | Day 2, 12 hours post-dose (N=14, 14) | 4.500 mmol/L | Standard Deviation 0.2961 |