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
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
No text entered.

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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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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 ]

2.  Secondary:   Cumulative Incidence of the First Serious Asthma Exacerbation Resulting in Hospitalization, Intubation or Death.   [ Time Frame: up to 21 months ]

3.  Secondary:   Patients With Asthma Exacerbations That Required Treatment With Systemic Corticosteroids   [ Time Frame: Up to 21 months ]

4.  Secondary:   Number of Patients With at Least One Asthma Worsening Post-baseline   [ Time Frame: Up to 21 months ]

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) ]

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 ]

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 ]

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) ]

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) ]

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) ]

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) ]

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) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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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 agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00941798     History of Changes
Other Study ID Numbers: CQMF149A2210, EudraCT number 2009-011539-10
Study First Received: July 14, 2009
Results First Received: May 3, 2012
Last Updated: August 21, 2012
Health Authority: United States: Food and Drug Administration
India: Drugs Controller General of India
Slovakia: State Institute for Drug Control
Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Korea: Food and Drug Administration