Trial record 1 of 1 for:    NCT01285492.
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Long Term Safety and Tolerability of QVA149 Versus Tiotropium in Japanese Patients With Chronic Obstructive Pulmonary Disease (COPD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01285492
First received: January 25, 2011
Last updated: December 3, 2013
Last verified: December 2013
Results First Received: September 4, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease (COPD)
Interventions: Drug: QVA149
Drug: Tiotropium

  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
121 patients were randomized to the QVA149 group; however, demographics was on safety set and excluded 2 patients who did not take study drug

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was a pre-screening visit where informed consent was obtained and current COPD medications reviewed and in suitable patients, if necessary, arrangements were made to adjust prohibited COPD therapy to allowable COPD therapy. The interval between Visit 2 and 3 was a 7-days run-in period used to assess eligibility and to collect baseline values.

Reporting Groups
  Description
QVA149 QVA149 110/50 μg o.d. (once a day)
Tiotropium tiotropium 18 μg o.d.

Participant Flow:   Overall Study
    QVA149     Tiotropium  
STARTED     121 [1]   39 [1]
Safety Set (for Demographics)     119 [2]   39 [3]
COMPLETED     104     38  
NOT COMPLETED     17     1  
Adverse Event                 11                 0  
Protocol Violation                 3                 0  
Withdrawal by Subject                 2                 1  
Death                 1                 0  
[1] All patients randomized to this group
[2] All patients who took study drug; 2 patients did not
[3] All patients who took study drug



  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
QVA149 QVA149 110/50 μg once a day (o.d)
Tiotropium tiotropium 18 μg o.d.
Total Total of all reporting groups

Baseline Measures
    QVA149     Tiotropium     Total  
Number of Participants  
[units: participants]
  119     39     158  
Age  
[units: years]
Mean ± Standard Deviation
  69.3  ± 6.79     69.4  ± 6.90     69.3  ± 6.80  
Gender  
[units: Participants]
     
Female     5     2     7  
Male     114     37     151  
Baseline Weight  
[units: kg]
Mean ± Standard Deviation
  60.38  ± 9.613     61.44  ± 8.788     60.64  ± 9.400  
Baseline Height  
[units: cm]
Mean ± Standard Deviation
  164.4  ± 7.08     163.3  ± 6.38     164.1  ± 6.91  
Baseline Body Mass Index  
[units: kg/m^2]
Mean ± Standard Deviation
  22.31  ± 3.067     23.02  ± 2.919     22.49  ± 3.037  



  Outcome Measures
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1.  Primary:   Number of Participants With Adverse Events (AEs), Serious Adverse Events (SAEs) or Death   [ Time Frame: 52 weeks ]

2.  Secondary:   Number of Patients With Newly Occurring or Worsening Clinically Notable Hematology Values at Any Timepoint Over the Whole Treatment Period   [ Time Frame: 52 weeks ]

3.  Secondary:   Number of Patients With Newly Occurring or Worsening Clinically Notable Biochemistry Values at Any Time-point Over the Treatment Period   [ Time Frame: 52 weeks ]

4.  Secondary:   Number of Patients With Newly Occurring or Worsening Clinically Notable Vital Signs Values at Any Time-point Over the Whole Treatment Period   [ Time Frame: 52 weeks ]

5.  Secondary:   Number of Patients With Newly Occurring or Worsening Clinically Notable Fridericia’s QTc Values at Any Time-point Over the Whole Treatment Period   [ Time Frame: 52 weeks ]

6.  Secondary:   Change in Pre-dose Forced Expiratory Volume in One Second (FEV1) From Baseline   [ Time Frame: Weeks 3, 6, 12, 24, 36, 52 ]

7.  Secondary:   Change in Pre-dose Forced Vital Capacity (FVC) From Baseline   [ Time Frame: Weeks 3, 6, 12, 24, 36, 52 ]


  Serious Adverse Events


  Other Adverse Events


  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.


Limitations and Caveats
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
No text entered.  


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300
e-mail: trialandresults.registries@novartis.com


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01285492     History of Changes
Other Study ID Numbers: CQVA149A1301
Study First Received: January 25, 2011
Results First Received: September 4, 2013
Last Updated: December 3, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare