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Safety of QMF149 Twisthaler® in Adolescent and Adult Patients With Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00941798
First received: July 14, 2009
Last updated: August 21, 2012
Last verified: August 2012
History of Changes
Results First Received: May 3, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: QMF149 Twisthaler®
Drug: Mometasone Twisthaler®

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
2283 patients were screened. 1518 patients were randomized.

Reporting Groups
  Description
QMF149 Twisthaler® 500/400 QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
Mometasone Twisthaler® Mometasone Twisthaler®, 400 µg QD

Participant Flow:   Overall Study
    QMF149 Twisthaler® 500/400     Mometasone Twisthaler®  
STARTED     755     763  
Full Analysis Set     749     759  
COMPLETED     561     578  
NOT COMPLETED     194     185  
Withdrawal by Subject                 72                 74  
Adverse Event                 43                 23  
Lost to Follow-up                 29                 23  
Protocol Violation                 17                 20  
Administrative problems                 13                 23  
Lack of Efficacy                 10                 17  
Patient's inability to use device                 6                 1  
Abnormal test procedure results                 3                 1  
Abnormal laboratory values                 1                 2  
Death                 0                 1  



  Baseline Characteristics
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Reporting Groups
  Description
QMF149 Twisthaler® 500/400 QMF149 Twisthaler® (indacaterol maleate 500 µg/mometasone furoate 400 µg), once daily (QD)
Mometasone Twisthaler® Mometasone Twisthaler®, 400 µg QD
Total Total of all reporting groups

Baseline Measures
    QMF149 Twisthaler® 500/400     Mometasone Twisthaler®     Total  
Number of Participants  
[units: participants]
 		  749     759     1508  
Age  
[units: years]
Mean ± Standard Deviation 		  42.4  ± 14.75     42.3  ± 14.58     42.3  ± 14.66  
Gender  
[units: participants]
 		     
Female     436     449     885  
Male     313     310     623  



  Outcome Measures
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1.  Primary:   Time to First Serious Asthma Exacerbation   [ Time Frame: Up to 21 months ]
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2.  Secondary:   Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death.   [ Time Frame: up to 21 months ]
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3.  Secondary:   Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids   [ Time Frame: Up to 21 months ]
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4.  Secondary:   Number of Patients With at Least One Asthma Worsening Post-baseline   [ Time Frame: Up to 21 months ]
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5.  Secondary:   Change From Baseline in Trough Forced Expiration Volume in 1 Second (FEV1) at Final Visit   [ Time Frame: Baseline to the end of treatment (varying durations, up to 21 months) ]
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6.  Secondary:   Change From Baseline in Forced Expiration Volume in 1 Second (FEV1) at Final Visit   [ Time Frame: Baseline to the end of treatment (varying durations, up to 21 months). At the following timepoints: 5 minutes post-dose, 30 minutes post-dose, 1 hour post-dose and 2 hours post-dose ]
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7.  Secondary:   Change From Baseline in Forced Vital Capacity (FVC) at Final Visit   [ Time Frame: Baseline to the end of treatment (varying durations, up to 21 months). At the following timepoints: 5 minutes post-dose, 30 minutes post-dose, 1 hour post-dose and 2 hours post-dose ]
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8.  Secondary:   Changes From Baseline in Morning Peak Expiratory Flow (PEF) and Trough Evening PEF Averaged Over the Entire Post-baseline Period   [ Time Frame: Baseline to the end of treatment (varying durations, up to 21 months) ]
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9.  Secondary:   Change From Baseline in Percentage of Days With no Asthma Symptoms During the Morning, Daytime and Nighttime   [ Time Frame: Baseline to the end of treatment (varying durations, up to 21 months) ]
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10.  Secondary:   Change From Baseline in Average Asthma Symptom Score Total, Daytime and Nighttime   [ Time Frame: Baseline to the end of treatment (varying durations, up to 21 months) ]
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11.  Secondary:   Change From Baseline in Percentage of Days With no Rescue Medication Use During 24 Hours, Daytime and Nighttime   [ Time Frame: Baseline to the end of treatment (varying durations, up to 21 months) ]
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12.  Secondary:   Change From Baseline in Asthma Control Questionnaire (ACQ) at Final Visit   [ Time Frame: Baseline to the end of treatment (varying durations, up to 21 months) ]
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  Serious Adverse Events
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  Other Adverse Events
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  More Information
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