Trial Outcomes & Findings for Safety and Tolerability of Indacaterol Maleate/Mometasone Furoate Delivered Via the Twisthaler® Device After 14 Days Treatment in Patients With Mild to Moderate Asthma (NCT NCT00605306)
NCT ID: NCT00605306
Last Updated: 2013-04-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
28 participants
Primary outcome timeframe
15 days
Results posted on
2013-04-22
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
14
|
14
|
|
Overall Study
COMPLETED
|
14
|
13
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Safety and Tolerability of Indacaterol Maleate/Mometasone Furoate Delivered Via the Twisthaler® Device After 14 Days Treatment in Patients With Mild to Moderate Asthma
Baseline characteristics by cohort
| Measure |
Indacaterol Maleate/Mometasone Furoate
n=14 Participants
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.
|
Placebo
n=14 Participants
Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
31.0 years
STANDARD_DEVIATION 7.18 • n=5 Participants
|
33.9 years
STANDARD_DEVIATION 13.35 • n=7 Participants
|
32.4 years
STANDARD_DEVIATION 10.62 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 15 daysPopulation: All participants
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.
Outcome measures
| Measure |
Indacaterol Maleate/Mometasone Furoate
n=14 Participants
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.
|
Placebo
n=14 Participants
Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
|
|---|---|---|
|
Participants With Adverse Events
Any adverse event
|
9 participants
|
12 participants
|
|
Participants With Adverse Events
Serious adverse event
|
0 participants
|
0 participants
|
|
Participants With Adverse Events
AE resulting in discontinuation
|
0 participants
|
1 participants
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Indacaterol Maleate/Mometasone Furoate
n=14 Participants
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.
|
Placebo
n=14 Participants
Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
|
|---|---|---|
|
Levels of Serum Potassium Over Time
Baseline (N=14, 14)
|
4.271 mmol/L
Standard Deviation 0.2867
|
4.336 mmol/L
Standard Deviation 0.3388
|
|
Levels of Serum Potassium Over Time
Day 1, pre-dose (N=14, 14)
|
4.264 mmol/L
Standard Deviation 0.2240
|
4.279 mmol/L
Standard Deviation 0.3446
|
|
Levels of Serum Potassium Over Time
Day 1, 0.25 hours post-dose (N=14, 14)
|
4.293 mmol/L
Standard Deviation 0.3583
|
4.314 mmol/L
Standard Deviation 0.5803
|
|
Levels of Serum Potassium Over Time
Day 1, 0.5 hours post-dose (N=14, 14)
|
4.150 mmol/L
Standard Deviation 0.2442
|
4.179 mmol/L
Standard Deviation 0.3093
|
|
Levels of Serum Potassium Over Time
Day 1, 1 hour post-dose (N=14, 14)
|
4.143 mmol/L
Standard Deviation 0.2174
|
4.171 mmol/L
Standard Deviation 0.2614
|
|
Levels of Serum Potassium Over Time
Day 1, 2 hours post-dose (N=14, 14)
|
4.157 mmol/L
Standard Deviation 0.2709
|
4.093 mmol/L
Standard Deviation 0.2200
|
|
Levels of Serum Potassium Over Time
Day 1, 4 hours post-dose (N=14, 14)
|
3.979 mmol/L
Standard Deviation 0.2486
|
3.929 mmol/L
Standard Deviation 0.2494
|
|
Levels of Serum Potassium Over Time
Day 2, 12 hours post-dose (N=14, 14)
|
4.436 mmol/L
Standard Deviation 0.2530
|
4.500 mmol/L
Standard Deviation 0.2961
|
|
Levels of Serum Potassium Over Time
Day 2, 24 hours post-dose (N=14, 14)
|
4.293 mmol/L
Standard Deviation 0.2786
|
4.386 mmol/L
Standard Deviation 0.4753
|
|
Levels of Serum Potassium Over Time
Day 14, pre-dose (N=14, 14)
|
4.150 mmol/L
Standard Deviation 0.3205
|
4.136 mmol/L
Standard Deviation 0.3079
|
|
Levels of Serum Potassium Over Time
Day 14, 0.25 hours post-dose (N=14, 13)
|
4.064 mmol/L
Standard Deviation 0.3522
|
4.092 mmol/L
Standard Deviation 0.3353
|
|
Levels of Serum Potassium Over Time
Day 14, 0.5 hours post-dose (N=14, 13)
|
3.986 mmol/L
Standard Deviation 0.3325
|
4.092 mmol/L
Standard Deviation 0.3378
|
|
Levels of Serum Potassium Over Time
Day 14, 1 hour post-dose (N=14, 13)
|
3.986 mmol/L
Standard Deviation 0.3880
|
4.038 mmol/L
Standard Deviation 0.4426
|
|
Levels of Serum Potassium Over Time
Day 14, 2 hours post-dose (N=14, 13)
|
3.986 mmol/L
Standard Deviation 0.2627
|
4.038 mmol/L
Standard Deviation 0.3927
|
|
Levels of Serum Potassium Over Time
Day 14, 4 hours post-dose (N=14, 13)
|
3.800 mmol/L
Standard Deviation 0.3397
|
3.792 mmol/L
Standard Deviation 0.2397
|
|
Levels of Serum Potassium Over Time
End of study (N=14, 14)
|
4.364 mmol/L
Standard Deviation 0.2373
|
4.429 mmol/L
Standard Deviation 0.4103
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Indacaterol Maleate/Mometasone Furoate
n=14 Participants
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.
|
Placebo
n=14 Participants
Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
|
|---|---|---|
|
Levels of Plasma Glucose Over Time
Baseline (N=14, 14)
|
5.079 mmol/L
Standard Deviation 0.3239
|
5.157 mmol/L
Standard Deviation 0.4415
|
|
Levels of Plasma Glucose Over Time
Day 1, pre-dose (N=14, 14)
|
5.057 mmol/L
Standard Deviation 0.2533
|
5.236 mmol/L
Standard Deviation 0.3855
|
|
Levels of Plasma Glucose Over Time
Day 1, 0.25 hours post-dose (N=14, 14)
|
5.007 mmol/L
Standard Deviation 0.2786
|
5.264 mmol/L
Standard Deviation 0.4069
|
|
Levels of Plasma Glucose Over Time
Day 1, 0.5 hours post-dose (N=14, 14)
|
4.950 mmol/L
Standard Deviation 0.2279
|
5.207 mmol/L
Standard Deviation 0.3385
|
|
Levels of Plasma Glucose Over Time
Day 1, 1 hour post-dose (N=14, 14)
|
5.036 mmol/L
Standard Deviation 0.2620
|
5.193 mmol/L
Standard Deviation 0.3316
|
|
Levels of Plasma Glucose Over Time
Day 1, 2 hours post-dose (N=14, 14)
|
5.057 mmol/L
Standard Deviation 0.2377
|
5.179 mmol/L
Standard Deviation 0.3142
|
|
Levels of Plasma Glucose Over Time
Day 1, 4 hours post-dose (N=14, 14)
|
7.064 mmol/L
Standard Deviation 1.4532
|
6.793 mmol/L
Standard Deviation 1.2344
|
|
Levels of Plasma Glucose Over Time
Day 2, 12 hours post-dose (N=14, 14)
|
5.221 mmol/L
Standard Deviation 0.2326
|
5.286 mmol/L
Standard Deviation 0.3009
|
|
Levels of Plasma Glucose Over Time
Day 2, 24 hours post-dose (N=14, 14)
|
5.293 mmol/L
Standard Deviation 0.4463
|
5.321 mmol/L
Standard Deviation 0.5767
|
|
Levels of Plasma Glucose Over Time
Day 14, pre-dose (N=14, 14)
|
5.129 mmol/L
Standard Deviation 0.4681
|
5.221 mmol/L
Standard Deviation 0.3534
|
|
Levels of Plasma Glucose Over Time
Day 14, 0.25 hours post-dose (N=14, 13)
|
5.136 mmol/L
Standard Deviation 0.4986
|
4.900 mmol/L
Standard Deviation 0.4301
|
|
Levels of Plasma Glucose Over Time
Day 14, 0.5 hours post-dose (N=14, 13)
|
5.157 mmol/L
Standard Deviation 0.4767
|
4.946 mmol/L
Standard Deviation 0.4409
|
|
Levels of Plasma Glucose Over Time
Day 14, 1 hour post-dose (N=14, 13)
|
5.136 mmol/L
Standard Deviation 0.4448
|
4.962 mmol/L
Standard Deviation 0.3841
|
|
Levels of Plasma Glucose Over Time
Day 14, 2 hours post-dose (N=14, 13)
|
5.093 mmol/L
Standard Deviation 0.3269
|
4.908 mmol/L
Standard Deviation 0.4173
|
|
Levels of Plasma Glucose Over Time
Day 14, 4 hours post-dose (N=14, 13)
|
6.929 mmol/L
Standard Deviation 1.3176
|
7.408 mmol/L
Standard Deviation 1.0649
|
|
Levels of Plasma Glucose Over Time
End of study (N=14, 13)
|
5.257 mmol/L
Standard Deviation 0.2821
|
5.731 mmol/L
Standard Deviation 1.0160
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Indacaterol Maleate/Mometasone Furoate
n=14 Participants
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.
|
Placebo
n=14 Participants
Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
|
|---|---|---|
|
Levels of Serum Cortisol Over Time
Baseline (N=14, 14)
|
466.214 mmol/L
Standard Deviation 178.2311
|
441.143 mmol/L
Standard Deviation 97.5365
|
|
Levels of Serum Cortisol Over Time
Day 1, pre-dose (N=14, 14)
|
159.643 mmol/L
Standard Deviation 100.4533
|
140.714 mmol/L
Standard Deviation 47.2024
|
|
Levels of Serum Cortisol Over Time
Day 1, 0.25 hours post-dose (N=14, 14)
|
153.786 mmol/L
Standard Deviation 87.5313
|
151.000 mmol/L
Standard Deviation 91.2798
|
|
Levels of Serum Cortisol Over Time
Day 1, 0.5 hours post-dose (N=14, 14)
|
130.143 mmol/L
Standard Deviation 74.2375
|
130.571 mmol/L
Standard Deviation 63.6779
|
|
Levels of Serum Cortisol Over Time
Day 1, 1 hour post-dose (N=14, 14)
|
99.143 mmol/L
Standard Deviation 54.5412
|
131.929 mmol/L
Standard Deviation 51.4923
|
|
Levels of Serum Cortisol Over Time
Day 1, 2 hours post-dose (N=14, 14)
|
65.357 mmol/L
Standard Deviation 33.1143
|
84.286 mmol/L
Standard Deviation 27.1220
|
|
Levels of Serum Cortisol Over Time
Day 1, 4 hours post-dose (N=14, 14)
|
55.929 mmol/L
Standard Deviation 24.6716
|
102.071 mmol/L
Standard Deviation 54.8248
|
|
Levels of Serum Cortisol Over Time
Day 2, 11 hours post-dose (N=14, 14)
|
362.500 mmol/L
Standard Deviation 159.3891
|
478.214 mmol/L
Standard Deviation 121.2272
|
|
Levels of Serum Cortisol Over Time
Day 2, 12 hours post-dose (N=14, 14)
|
289.929 mmol/L
Standard Deviation 96.3906
|
404.214 mmol/L
Standard Deviation 123.4623
|
|
Levels of Serum Cortisol Over Time
Day 2, 13 hours post-dose (N=14, 14)
|
335.214 mmol/L
Standard Deviation 150.7811
|
370.071 mmol/L
Standard Deviation 105.2451
|
|
Levels of Serum Cortisol Over Time
Day 2, 24 hours post-dose (N=14, 14)
|
136.857 mmol/L
Standard Deviation 75.4442
|
193.500 mmol/L
Standard Deviation 87.5238
|
|
Levels of Serum Cortisol Over Time
Day 14, pre-dose (N=14, 14)
|
126.071 mmol/L
Standard Deviation 65.6546
|
122.857 mmol/L
Standard Deviation 71.5379
|
|
Levels of Serum Cortisol Over Time
Day 14, 0.25 hours post-dose (N=14, 13)
|
111.500 mmol/L
Standard Deviation 82.9001
|
127.231 mmol/L
Standard Deviation 104.5834
|
|
Levels of Serum Cortisol Over Time
Day 14, 0.5 hours post-dose (N=14, 13)
|
99.500 mmol/L
Standard Deviation 68.5608
|
121.154 mmol/L
Standard Deviation 112.2726
|
|
Levels of Serum Cortisol Over Time
Day 14, 1 hour post-dose (N=14, 13)
|
82.786 mmol/L
Standard Deviation 57.7663
|
106.385 mmol/L
Standard Deviation 118.7936
|
|
Levels of Serum Cortisol Over Time
Day 14, 2 hours post-dose (N=14, 13)
|
62.071 mmol/L
Standard Deviation 44.5861
|
94.154 mmol/L
Standard Deviation 133.8300
|
|
Levels of Serum Cortisol Over Time
Day 14, 4 hours post-dose (N=14, 13)
|
48.214 mmol/L
Standard Deviation 34.5280
|
102.154 mmol/L
Standard Deviation 80.7051
|
|
Levels of Serum Cortisol Over Time
Day 15, 11 hours post-dose (N=14, 14)
|
242.143 mmol/L
Standard Deviation 177.3739
|
417.000 mmol/L
Standard Deviation 100.8312
|
|
Levels of Serum Cortisol Over Time
Day 15, 12 hours post-dose (N=14, 13)
|
255.500 mmol/L
Standard Deviation 154.1442
|
388.769 mmol/L
Standard Deviation 104.6885
|
|
Levels of Serum Cortisol Over Time
Day 15, 13 hours post-dose (N=14, 13)
|
324.857 mmol/L
Standard Deviation 179.8713
|
385.769 mmol/L
Standard Deviation 126.2301
|
|
Levels of Serum Cortisol Over Time
End of study (N=14, 14)
|
495.286 mmol/L
Standard Deviation 259.2054
|
417.786 mmol/L
Standard Deviation 164.1046
|
Adverse Events
Indacaterol Maleate/Mometasone Furoate
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Indacaterol Maleate/Mometasone Furoate
n=14 participants at risk
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.
|
Placebo
n=14 participants at risk
Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
|
|---|---|---|
|
Eye disorders
Blepharitis
|
0.00%
0/14
|
7.1%
1/14
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/14
|
7.1%
1/14
|
|
General disorders
Chest discomfort
|
0.00%
0/14
|
14.3%
2/14
|
|
General disorders
Chills
|
0.00%
0/14
|
7.1%
1/14
|
|
Infections and infestations
Bronchitis
|
14.3%
2/14
|
0.00%
0/14
|
|
Infections and infestations
Nasopharyngitis
|
7.1%
1/14
|
0.00%
0/14
|
|
Infections and infestations
Rhinitis
|
14.3%
2/14
|
14.3%
2/14
|
|
Infections and infestations
Tracheitis
|
7.1%
1/14
|
0.00%
0/14
|
|
Investigations
Peak expiratory flow rate decreased
|
0.00%
0/14
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/14
|
7.1%
1/14
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
7.1%
1/14
|
0.00%
0/14
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/14
|
7.1%
1/14
|
|
Nervous system disorders
Aphonia
|
7.1%
1/14
|
0.00%
0/14
|
|
Nervous system disorders
Headache
|
35.7%
5/14
|
14.3%
2/14
|
|
Nervous system disorders
Syncope vasovagal
|
0.00%
0/14
|
7.1%
1/14
|
|
Nervous system disorders
Tremor
|
0.00%
0/14
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/14
|
14.3%
2/14
|
|
Respiratory, thoracic and mediastinal disorders
Asthmatic crisis
|
0.00%
0/14
|
21.4%
3/14
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
35.7%
5/14
|
14.3%
2/14
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.1%
1/14
|
28.6%
4/14
|
|
Respiratory, thoracic and mediastinal disorders
Painful respiration
|
0.00%
0/14
|
7.1%
1/14
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
7.1%
1/14
|
0.00%
0/14
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/14
|
7.1%
1/14
|
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 (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER