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Safety and Tolerability of Indacaterol Maleate/Mometasone Furoate Delivered Via the Twisthaler® Device After 14 Days Treatment in Patients With Mild to Moderate Asthma

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ClinicalTrials.gov Identifier: NCT00605306
Recruitment Status : Completed
First Posted : January 31, 2008
Results First Posted : April 22, 2013
Last Update Posted : April 22, 2013
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Asthma
Interventions Drug: indacaterol maleate / mometasone furoate
Drug: placebo to indacaterol maleate/mometasone furoate
Enrollment 28
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Indacaterol Maleate/Mometasone Furoate Placebo
Hide Arm/Group Description 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. Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
Period Title: Overall Study
Started 14 14
Completed 14 13
Not Completed 0 1
Reason Not Completed
Adverse Event             0             1
Arm/Group Title Indacaterol Maleate/Mometasone Furoate Placebo Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 14 14 28
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 14 participants 14 participants 28 participants
31.0  (7.18) 33.9  (13.35) 32.4  (10.62)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 14 participants 14 participants 28 participants
Female
7
  50.0%
6
  42.9%
13
  46.4%
Male
7
  50.0%
8
  57.1%
15
  53.6%
1.Primary Outcome
Title Participants With Adverse Events
Hide Description

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
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Indacaterol Maleate/Mometasone Furoate Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 14 14
Measure Type: Number
Unit of Measure: participants
Any adverse event 9 12
Serious adverse event 0 0
AE resulting in discontinuation 0 1
2.Secondary Outcome
Title Levels of Serum Potassium Over Time
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Indacaterol Maleate/Mometasone Furoate Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: mmol/L
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)
3.Secondary Outcome
Title Levels of Plasma Glucose Over Time
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Indacaterol Maleate/Mometasone Furoate Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: mmol/L
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)
4.Secondary Outcome
Title Levels of Serum Cortisol Over Time
Hide Description 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).
Hide Outcome Measure Data
Hide Analysis Population Description
All participants
Arm/Group Title Indacaterol Maleate/Mometasone Furoate Placebo
Hide Arm/Group Description:
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.
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 Number of Participants Analyzed 14 14
Mean (Standard Deviation)
Unit of Measure: mmol/L
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)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Indacaterol Maleate/Mometasone Furoate Placebo
Hide Arm/Group Description 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. Participants received 2 inhalations of placebo to indacaterol maleate / mometasone furoate once daily in the evening delivered via the Twisthaler device for 14 days.
All-Cause Mortality
Indacaterol Maleate/Mometasone Furoate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Indacaterol Maleate/Mometasone Furoate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/14 (0.00%)   0/14 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Indacaterol Maleate/Mometasone Furoate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   9/14 (64.29%)   12/14 (85.71%) 
Eye disorders     
Blepharitis   0/14 (0.00%)  1/14 (7.14%) 
Conjunctivitis   0/14 (0.00%)  1/14 (7.14%) 
General disorders     
Chest discomfort   0/14 (0.00%)  2/14 (14.29%) 
Chills   0/14 (0.00%)  1/14 (7.14%) 
Infections and infestations     
Bronchitis   2/14 (14.29%)  0/14 (0.00%) 
Nasopharyngitis   1/14 (7.14%)  0/14 (0.00%) 
Rhinitis   2/14 (14.29%)  2/14 (14.29%) 
Tracheitis   1/14 (7.14%)  0/14 (0.00%) 
Investigations     
Peak expiratory flow rate decreased   0/14 (0.00%)  1/14 (7.14%) 
Musculoskeletal and connective tissue disorders     
Arthralgia   0/14 (0.00%)  1/14 (7.14%) 
Myalgia   1/14 (7.14%)  0/14 (0.00%) 
Pain in extremity   0/14 (0.00%)  1/14 (7.14%) 
Nervous system disorders     
Aphonia   1/14 (7.14%)  0/14 (0.00%) 
Headache   5/14 (35.71%)  2/14 (14.29%) 
Syncope vasovagal   0/14 (0.00%)  1/14 (7.14%) 
Tremor   0/14 (0.00%)  1/14 (7.14%) 
Respiratory, thoracic and mediastinal disorders     
Asthma   0/14 (0.00%)  2/14 (14.29%) 
Asthmatic crisis   0/14 (0.00%)  3/14 (21.43%) 
Cough   5/14 (35.71%)  2/14 (14.29%) 
Dyspnoea   1/14 (7.14%)  4/14 (28.57%) 
Painful respiration   0/14 (0.00%)  1/14 (7.14%) 
Oropharyngeal pain   1/14 (7.14%)  0/14 (0.00%) 
Wheezing   0/14 (0.00%)  1/14 (7.14%) 
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Layout table for additonal information
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00605306    
Other Study ID Numbers: CQMF149A2203
First Submitted: January 18, 2008
First Posted: January 31, 2008
Results First Submitted: March 11, 2013
Results First Posted: April 22, 2013
Last Update Posted: April 22, 2013