A Phase 2 interventional study of indacaterol maleate / mometasone furoate and placebo to indacaterol maleate/mometasone furoate in Asthma, sponsored by Novartis. Completed at 3 sites in France. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2013-04-22.
Sponsored by Novartis · Phase 2, Interventional, and Treatment
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.
3,921 studies on the registry are indexed under Asthma; 507 are open to participants now.
This study's enrollment of 28 is below the median of 83 across 2,752 interventional studies indexed under Asthma.
Browse Asthma studies →Novartis is the lead sponsor of 703 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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.
Drug: indacaterol maleate / mometasone furoate
Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
Drug: placebo to indacaterol maleate/mometasone furoate
Indacaterol maleate / mometasone furoate 250/400 μg, 2 puffs once daily delivered via the Twisthaler device.
Also known as: QMF149
Placebo to indacaterol maleate/mometasone furoate delivered via the Twisthaler device.
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
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).
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).
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).
| Milestone | Indacaterol Maleate/Mometasone Furoate | Placebo |
|---|---|---|
| Started | 14 | 14 |
| Completed | 14 | 13 |
| Not completed | 0 | 1 |
| Withdrew: Adverse event | 0 | 1 |
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.
| participants | Indacaterol Maleate/Mometasone Furoate | Placebo |
|---|---|---|
| Any adverse event | 9 | 12 |
| Serious adverse event | 0 | 0 |
| AE resulting in discontinuation | 0 | 1 |
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.
| mmol/L | Indacaterol Maleate/Mometasone Furoate | Placebo |
|---|---|---|
| Baseline (N=14, 14) | 4.271 ± 0.2867 | 4.336 ± 0.3388 |
| Day 1, pre-dose (N=14, 14) | 4.264 ± 0.2240 | 4.279 ± 0.3446 |
| Day 1, 0.25 hours post-dose (N=14, 14) | 4.293 ± 0.3583 | 4.314 ± 0.5803 |
| Day 1, 0.5 hours post-dose (N=14, 14) | 4.150 ± 0.2442 | 4.179 ± 0.3093 |
| Day 1, 1 hour post-dose (N=14, 14) | 4.143 ± 0.2174 | 4.171 ± 0.2614 |
| Day 1, 2 hours post-dose (N=14, 14) | 4.157 ± 0.2709 | 4.093 ± 0.2200 |
| Day 1, 4 hours post-dose (N=14, 14) | 3.979 ± 0.2486 | 3.929 ± 0.2494 |
| Day 2, 12 hours post-dose (N=14, 14) | 4.436 ± 0.2530 | 4.500 ± 0.2961 |
| Day 2, 24 hours post-dose (N=14, 14) | 4.293 ± 0.2786 | 4.386 ± 0.4753 |
| Day 14, pre-dose (N=14, 14) | 4.150 ± 0.3205 | 4.136 ± 0.3079 |
| Day 14, 0.25 hours post-dose (N=14, 13) | 4.064 ± 0.3522 | 4.092 ± 0.3353 |
| Day 14, 0.5 hours post-dose (N=14, 13) | 3.986 ± 0.3325 | 4.092 ± 0.3378 |
| Day 14, 1 hour post-dose (N=14, 13) | 3.986 ± 0.3880 | 4.038 ± 0.4426 |
| Day 14, 2 hours post-dose (N=14, 13) | 3.986 ± 0.2627 | 4.038 ± 0.3927 |
| Day 14, 4 hours post-dose (N=14, 13) | 3.800 ± 0.3397 | 3.792 ± 0.2397 |
| End of study (N=14, 14) | 4.364 ± 0.2373 | 4.429 ± 0.4103 |
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.
| mmol/L | Indacaterol Maleate/Mometasone Furoate | Placebo |
|---|---|---|
| Baseline (N=14, 14) | 5.079 ± 0.3239 | 5.157 ± 0.4415 |
| Day 1, pre-dose (N=14, 14) | 5.057 ± 0.2533 | 5.236 ± 0.3855 |
| Day 1, 0.25 hours post-dose (N=14, 14) | 5.007 ± 0.2786 | 5.264 ± 0.4069 |
| Day 1, 0.5 hours post-dose (N=14, 14) | 4.950 ± 0.2279 | 5.207 ± 0.3385 |
| Day 1, 1 hour post-dose (N=14, 14) | 5.036 ± 0.2620 | 5.193 ± 0.3316 |
| Day 1, 2 hours post-dose (N=14, 14) | 5.057 ± 0.2377 | 5.179 ± 0.3142 |
| Day 1, 4 hours post-dose (N=14, 14) | 7.064 ± 1.4532 | 6.793 ± 1.2344 |
| Day 2, 12 hours post-dose (N=14, 14) | 5.221 ± 0.2326 | 5.286 ± 0.3009 |
| Day 2, 24 hours post-dose (N=14, 14) | 5.293 ± 0.4463 | 5.321 ± 0.5767 |
| Day 14, pre-dose (N=14, 14) | 5.129 ± 0.4681 | 5.221 ± 0.3534 |
| Day 14, 0.25 hours post-dose (N=14, 13) | 5.136 ± 0.4986 | 4.900 ± 0.4301 |
| Day 14, 0.5 hours post-dose (N=14, 13) | 5.157 ± 0.4767 | 4.946 ± 0.4409 |
| Day 14, 1 hour post-dose (N=14, 13) | 5.136 ± 0.4448 | 4.962 ± 0.3841 |
| Day 14, 2 hours post-dose (N=14, 13) | 5.093 ± 0.3269 | 4.908 ± 0.4173 |
| Day 14, 4 hours post-dose (N=14, 13) | 6.929 ± 1.3176 | 7.408 ± 1.0649 |
| End of study (N=14, 13) | 5.257 ± 0.2821 | 5.731 ± 1.0160 |
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.
| mmol/L | Indacaterol Maleate/Mometasone Furoate | Placebo |
|---|---|---|
| Baseline (N=14, 14) | 466.214 ± 178.2311 | 441.143 ± 97.5365 |
| Day 1, pre-dose (N=14, 14) | 159.643 ± 100.4533 | 140.714 ± 47.2024 |
| Day 1, 0.25 hours post-dose (N=14, 14) | 153.786 ± 87.5313 | 151.000 ± 91.2798 |
| Day 1, 0.5 hours post-dose (N=14, 14) | 130.143 ± 74.2375 | 130.571 ± 63.6779 |
| Day 1, 1 hour post-dose (N=14, 14) | 99.143 ± 54.5412 | 131.929 ± 51.4923 |
| Day 1, 2 hours post-dose (N=14, 14) | 65.357 ± 33.1143 | 84.286 ± 27.1220 |
| Day 1, 4 hours post-dose (N=14, 14) | 55.929 ± 24.6716 | 102.071 ± 54.8248 |
| Day 2, 11 hours post-dose (N=14, 14) | 362.500 ± 159.3891 | 478.214 ± 121.2272 |
| Day 2, 12 hours post-dose (N=14, 14) | 289.929 ± 96.3906 | 404.214 ± 123.4623 |
| Day 2, 13 hours post-dose (N=14, 14) | 335.214 ± 150.7811 | 370.071 ± 105.2451 |
| Day 2, 24 hours post-dose (N=14, 14) | 136.857 ± 75.4442 | 193.500 ± 87.5238 |
| Day 14, pre-dose (N=14, 14) | 126.071 ± 65.6546 | 122.857 ± 71.5379 |
| Day 14, 0.25 hours post-dose (N=14, 13) | 111.500 ± 82.9001 | 127.231 ± 104.5834 |
| Day 14, 0.5 hours post-dose (N=14, 13) | 99.500 ± 68.5608 | 121.154 ± 112.2726 |
| Day 14, 1 hour post-dose (N=14, 13) | 82.786 ± 57.7663 | 106.385 ± 118.7936 |
| Day 14, 2 hours post-dose (N=14, 13) | 62.071 ± 44.5861 | 94.154 ± 133.8300 |
| Day 14, 4 hours post-dose (N=14, 13) | 48.214 ± 34.5280 | 102.154 ± 80.7051 |
| Day 15, 11 hours post-dose (N=14, 14) | 242.143 ± 177.3739 | 417.000 ± 100.8312 |
| Day 15, 12 hours post-dose (N=14, 13) | 255.500 ± 154.1442 | 388.769 ± 104.6885 |
| Day 15, 13 hours post-dose (N=14, 13) | 324.857 ± 179.8713 | 385.769 ± 126.2301 |
| End of study (N=14, 14) | 495.286 ± 259.2054 | 417.786 ± 164.1046 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Indacaterol Maleate/Mometasone Furoate | — | 0/14 (0%) | 9/14 (64.3%) |
| Placebo | — | 0/14 (0%) | 12/14 (85.7%) |
| Event | Indacaterol Maleate/Mometasone Furoate | Placebo |
|---|---|---|
| HeadacheNervous system disorders | 5/14 | 2/14 |
| CoughRespiratory, thoracic and mediastinal disorders | 5/14 | 2/14 |
| DyspnoeaRespiratory, thoracic and mediastinal disorders | 1/14 | 4/14 |
| Asthmatic crisisRespiratory, thoracic and mediastinal disorders | 0/14 | 3/14 |
| Chest discomfortGeneral disorders | 0/14 | 2/14 |
| BronchitisInfections and infestations | 2/14 | 0/14 |
| RhinitisInfections and infestations | 2/14 | 2/14 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 0/14 | 2/14 |
| BlepharitisEye disorders | 0/14 | 1/14 |
| ConjunctivitisEye disorders | 0/14 | 1/14 |
| Age Continuous(years) | Indacaterol Maleate/Mometasone Furoate | Placebo | Total |
|---|---|---|---|
| Mean | 31.0 ± 7.18 | 33.9 ± 13.35 | 32.4 ± 10.62 |
| Sex: Female, Male(Participants) | Indacaterol Maleate/Mometasone Furoate | Placebo | Total |
|---|---|---|---|
| Female | 7 | 6 | 13 |
| Male | 7 | 8 | 15 |
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