Efficacy, Safety and Pharmacokinetics of Indacaterol Acetate in Patients With Persistent Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01609478
First received: April 23, 2012
Last updated: August 27, 2014
Last verified: August 2014
Results First Received: June 27, 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: indacaterol
Drug: placebo
Drug: mometasone furoate

  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
Indacaterol Acetate 75 µg indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
Indacaterol Acetate 150 µg indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
Placebo placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od

Participant Flow:   Overall Study
    Indacaterol Acetate 75 µg     Indacaterol Acetate 150 µg     Placebo  
STARTED     111     108     116  
Full Analysis Set (FAS)     110     108     115  
COMPLETED     104     106     107  
NOT COMPLETED     7     2     9  
Adverse Event                 3                 1                 5  
Protocol Deviation                 0                 1                 1  
Non-Compliance with study treatment                 1                 0                 0  
Physician Decision                 1                 0                 1  
Withdrawal by Subject                 2                 0                 2  



  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
Indacaterol Acetate 75 µg indacaterol acetate 75 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
Indacaterol Acetate 150 µg indacaterol acetate 150 µg od delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
Placebo placebo delivered via Concept 1 inhaler Background therapy: mometasone furoate 200 mcg od
Total Total of all reporting groups

Baseline Measures
    Indacaterol Acetate 75 µg     Indacaterol Acetate 150 µg     Placebo     Total  
Number of Participants  
[units: participants]
  111     108     116     335  
Age  
[units: years]
Mean ± Standard Deviation
  50.7  ± 14.74     48.1  ± 13.53     49.8  ± 12.96     49.6  ± 13.76  
Gender  
[units: participants]
       
Female     59     60     61     180  
Male     52     48     55     155  



  Outcome Measures
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1.  Primary:   Trough Forced Expiratory Volume in One Second (FEV1) After 12 Weeks (Day 85)   [ Time Frame: after 12 weeks (Day 85) ]

2.  Secondary:   Asthma Control Questionnaire 5 (ACQ-5) After 12 Weeks (Day 85)   [ Time Frame: aftert 12 weeks (Day 85) ]

3.  Secondary:   Trough Forced Expiratory Volume in One Second (FEV1) After 2 Weeks (Day 15), 4 Weeks (Day 29), and 8 Weeks (Day 57) of Treatment.   [ Time Frame: Day 15, Day 29 and Day 57 ]

4.  Secondary:   Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 at All Time Points   [ Time Frame: Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 ]

5.  Secondary:   Forced Expiratory Volume in One Second (FEV1)/ Forced Vital Capacity (FVC) on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85   [ Time Frame: Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 ]

6.  Secondary:   Forced Expiratory Flow (FEF 25-75% )on Day 1, Day 2, Day 14, Day 15, Day 84, Day 85   [ Time Frame: Day 1, Day 2, Day 14, Day 15, Day 84, Day 85 ]

7.  Secondary:   Standardized Forced Expiratory Volume in One Second (FEV1) Area Under the Curve (AUC) at (5 Min - 4 h), (5 Min - 1 h) (1 h - 4 h) Measured on Day 1, 2 Weeks (Day 14)&12 Weeks (Day 84)   [ Time Frame: Day 1, 2 Weeks, 12 Weeks ]

8.  Secondary:   Peak Forced Expiratory Volume in 1 Second (FEV1) at Day 1, 2 Weeks (Day 14), 12 Weeks (Day 84)   [ Time Frame: Day 1, 2 weeks (Day 14), 12 weeks (Day 84) ]

9.  Secondary:   Asthma Control Questionnaire 5 (ACQ-5) After 4 Weeks (Day 29) and After 8 Weeks (Day 57) of Treatment   [ Time Frame: after 4 weeks (Day 29) and after 8 weeks (Day 57) ]

10.  Secondary:   Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 12 Weeks of Treatment. This is LS Mean of the Treatment Period.   [ Time Frame: baseline, 4weeks, 8 weeks and 12 weeks ]

11.  Secondary:   The Usage of Rescue Medication (Short Acting β2-agonist) Over 12 Weeks of Treatment   [ Time Frame: 12 weeks ]

12.  Secondary:   Asthma Quality of Life Questionnaire (AQLQ(S)) After 4 Weeks (Day 29) and 12 Weeks (Day 85) of Treatment   [ Time Frame: 4 Weeks, 12 Weeks ]

13.  Secondary:   Time to First Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period   [ Time Frame: 12 weeks ]

14.  Secondary:   The Annual Rate of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period   [ Time Frame: 12 weeks ]

15.  Secondary:   Duration of Asthma Exacerbations (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period   [ Time Frame: 12 weeks ]

16.  Secondary:   The Percentage of Patients With at Least One Asthma Exacerbation (Mild, Moderate, Severe, Moderate or Severe and Any) Over the 12 Week Treatment Period   [ Time Frame: 12 weeks ]

17.  Secondary:   Time to Permanent Study Discontinuation Due to Asthma Exacerbation Over the 12 Week Treatment Period   [ Time Frame: 12 weeks ]

18.  Secondary:   The Percentage of Patients Who Permanently Discontinued Study Due to Asthma Exacerbation Over the 12 Week Treatment Period   [ Time Frame: 12 weeks ]

19.  Secondary:   Total Amounts (in Doses) of Systemic Corticosteroids Used to Treat Asthma Exacerbations Over the 12 Week Treatment Period   [ Time Frame: 12 weeks ]

20.  Secondary:   Plasma Indacaterol Concentrations at Day 1 and Day 14   [ Time Frame: Day 1 and Day 14 ]


  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: NCT01609478     History of Changes
Other Study ID Numbers: CQMF149E2203, 2012-000520-18
Study First Received: April 23, 2012
Results First Received: June 27, 2014
Last Updated: August 27, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Germany: Federal Institute for Drugs and Medical Devices
Japan: Pharmaceuticals and Medical Devices Agency
Latvia: State Agency of Medicines
Netherlands: Medicines Evaluation Board (MEB)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Slovakia: State Institute for Drug Control
Bulgaria: Bulgarian Drug Agency
Korea: Food and Drug Administration