Safety and Efficacy of Mometasone Furoate Delivered Via Concept1 Device or Twisthaler® Device in Adult and Adolescent Patients With Persistent Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01555151
First received: March 13, 2012
Last updated: September 14, 2014
Last verified: September 2014
Results First Received: July 6, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: Mometasone furoate
Device: Concept 1
Device: 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
No text entered.

Reporting Groups
  Description
Mometasone Furoate 80 ug Daily Via the Concept1 Device Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
Mometasone Furoate 200 ug Daily Via the Twisthaler® Device Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
Mometasone Furoate 320 ug Daily Via the Concept1 Device Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
Mometasone Furoate 800 ug Via the Twisthaler® Device Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening

Participant Flow:   Overall Study
    Mometasone Furoate 80 ug Daily Via the Concept1 Device     Mometasone Furoate 200 ug Daily Via the Twisthaler® Device     Mometasone Furoate 320 ug Daily Via the Concept1 Device     Mometasone Furoate 800 ug Via the Twisthaler® Device  
STARTED     188     181     184     186  
Safety Set (SAF)     186     180     183     186  
COMPLETED     175     173     178     176  
NOT COMPLETED     13     8     6     10  
Withdrawal by Subject                 6                 2                 0                 2  
Administrative                 3                 1                 2                 0  
Protocol Violation                 3                 3                 3                 5  
Adverse Event                 1                 2                 1                 2  
Lost to Follow-up                 0                 0                 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.
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Reporting Groups
  Description
Mometasone Furoate 80 ug Daily Via the Concept1 Device Mometasone furoate (MF) delivered via Concept1, 80 μg daily in the evening
Mometasone Furoate 200 ug Daily Via the Twisthaler® Device Mometasone furoate delivered via Twisthaler®, 200 μg daily in the evening
Mometasone Furoate 320 ug Daily Via the Concept1 Device Mometasone furoate (MF) delivered via Concept1, 320 μg daily in the evening
Mometasone Furoate 800 ug Via the Twisthaler® Device Mometasone furoate delivered via Twisthaler®, 800 μg daily in the evening
Total Total of all reporting groups

Baseline Measures
    Mometasone Furoate 80 ug Daily Via the Concept1 Device     Mometasone Furoate 200 ug Daily Via the Twisthaler® Device     Mometasone Furoate 320 ug Daily Via the Concept1 Device     Mometasone Furoate 800 ug Via the Twisthaler® Device     Total  
Number of Participants  
[units: participants]
  188     181     184     186     739  
Age  
[units: years]
Mean ± Standard Deviation
  44.4  ± 16.33     45.9  ± 15.56     46.0  ± 16.18     45.5  ± 16.57     45.4  ± 16.15  
Gender  
[units: participants]
         
Female     98     94     113     97     402  
Male     90     87     71     89     337  



  Outcome Measures
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1.  Primary:   Trough Forced Expiratory Volume in 1 Second (FEV1)   [ Time Frame: Day 29 ]

2.  Secondary:   Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment   [ Time Frame: Days 8, 15 and 22 ]

3.  Secondary:   Forced Vital Capacity (FVC) at All Time Points   [ Time Frame: Days 1, 8, 15, 22, 28 and 29 at all time points ]

4.  Secondary:   Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points   [ Time Frame: Days 1, 8, 15, 22, 28 and 29 at all time points ]

5.  Secondary:   Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points   [ Time Frame: Days 1, 8, 15, 22, 28 and 29 at all time points ]

6.  Secondary:   Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment   [ Time Frame: Baseline and week 4 ]

7.  Secondary:   Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit   [ Time Frame: Baseline, days 8,15,22 and 29 ]

8.  Secondary:   Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over 4 Weeks of Treatment   [ Time Frame: Baseline and 4 weeks ]

9.  Secondary:   Percentage of Days With no Rescue Medication Use Over 4 Weeks of Treatment   [ Time Frame: 4 weeks ]

10.  Secondary:   Fractional Exhaled Nitric Oxide (FeNO)   [ Time Frame: Days 15 and 29 ]

11.  Secondary:   Plasma Cortisol Concentrations   [ Time Frame: Baseline, days 1 and 28 ]


  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: Clinical Disclosure Office
Organization: Novartis Pharmaceuticals
phone: +1(862)778-8300


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01555151     History of Changes
Other Study ID Numbers: CQMF149E2201, 2011-005100-14
Study First Received: March 13, 2012
Results First Received: July 6, 2014
Last Updated: September 14, 2014
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Estonia: The State Agency of Medicine
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute for Quality - and Organizational Development in Healthcare and Medicines/National Institute of Pharmacy
India: Drugs Controller General of India
Japan: Pharmaceuticals and Medical Devices Agency
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Expert Board (FSBI Scientific Center of Medical Application Expertise of Ministry of Health and Social Development of the Russian Federation)
Slovakia: State Institute for Drug Con
Thailand: Food and Drug Administration
Turkey: Ministry of Health
Ukraine: Ministry of Health