We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01120691.
Previous Study | Return to List | Next Study

Effect of QVA149 Versus NVA237 and Tiotropium on Chronic Obstructive Pulmonary Disorder (COPD) Exacerbations (SPARK)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01120691
First Posted: May 11, 2010
Last Update Posted: December 2, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
Results First Submitted: July 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Drug: QVA149
Drug: NVA237
Drug: tiotropium
Drug: Salbutamol/albuterol

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 3865 participants were screened of whom 2224 were randomized to 1 of the 3 treatment groups (QVA149, NVA237 or tiotropium) in a 1:1:1 ratio for at least 64 weeks (maximum 76 weeks) of treatment period.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
5 (QVA149), 2 (NVA237) and 3 (tiotropium) participants were randomized but did not receive study drug.

Reporting Groups
  Description
QVA149 QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period. Salbutamol/albuterol was available for rescue medication use throughout the study.
NVA237 NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period. Salbutamol/albuterol was available for rescue medication use throughout the study.
Open-label Tiotropium Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.

Participant Flow:   Overall Study
    QVA149   NVA237   Open-label Tiotropium
STARTED   741   741   742 
Full Analysis Set (FAS)   736   739   739 
Safety Set (SAF)   736   740   739 
Modified Safety Set (mSAF)   729   740   737 
Modified Full Analysis Set (mFAS)   729   739   737 
COMPLETED   570   538   559 
NOT COMPLETED   171   203   183 
Adverse Event                59                67                47 
Subject withdrew consent                33                50                44 
Death                21                22                24 
Unsatisfactory therapeutic effect                18                32                38 
Administrative problems                15                8                9 
Protocol deviation                13                12                12 
Lost to Follow-up                5                6                4 
Abnormal test procedure result(s)                3                2                1 
Patient's inability to use the device                3                1                0 
Abnormal laboratory value(s)                1                3                4 



  Baseline Characteristics
  Hide Baseline Characteristics

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.
The modified safety set (mSAF set) includes all patients in the safety set except patients from a site who had major GCP issues.

Reporting Groups
  Description
QVA149 QVA149 110/50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period. Salbutamol/albuterol was available for rescue medication use throughout the study.
NVA237 NVA237 50 μg capsules for inhalation, once daily delivered via Novartis Single Dose Dry Powder Inhaler (SDDPI) for at least 64 weeks of double blind treatment period. Salbutamol/albuterol was available for rescue medication use throughout the study.
Open-label Tiotropium Open-label tiotropium bromide 18 μg capsules for inhalation once daily delivered via HandiHaler® device for at least 64 weeks of double blind treatment period (study duration was up to 76 weeks). Salbutamol/albuterol was available for rescue medication use throughout the study.
Total Total of all reporting groups

Baseline Measures
   QVA149   NVA237   Open-label Tiotropium   Total 
Overall Participants Analyzed 
[Units: Participants]
 729   740   737   2206 
Age 
[Units: Years]
Mean (Standard Deviation)
 63.1  (8.07)   63.1  (7.98)   63.6  (7.79)   63.3  (7.95) 
Gender 
[Units: Participants]
       
Female   173   198   184   555 
Male   556   542   553   1651 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and NVA237 Treatment Arms During the Treatment Period.   [ Time Frame: 64 weeks ]

2.  Secondary:   Rate of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations in QVA149 and Open-label Tiotropium Treatment Arms During the Treatment Period.   [ Time Frame: 76 weeks ]

3.  Secondary:   Time to First Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbation Between QVA149, NVA237 and Open Label Tiotropium During the Treatment Period   [ Time Frame: 64 weeks ]

4.  Secondary:   Rate of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations Requiring the Use of Both Systemic Glucocorticosteroids and Antibiotics   [ Time Frame: 64 weeks ]

5.  Secondary:   Number of Days With Moderate or Severe Exacerbation That Required Treatment With Systemic Corticosteroids and Antibiotics   [ Time Frame: 64 weeks ]

6.  Secondary:   Time to Study Withdrawal or Premature Discontinuation for Any Reason Between QVA149 (110/50 µg q.d.), NVA237 (50 µg q.d.) and Open Label Tiotropium (18 µg q.d.) During the Treatment Period.   [ Time Frame: 64 weeks ]

7.  Secondary:   Percentage of Patients With Study Withdrawal or Premature Discontinuation for Any Reason Between QVA149 (110/50 µg q.d.), NVA237 (50 µg q.d.) and Open Label Tiotropium (18 µg q.d.)During the Treatment Period   [ Time Frame: 64 weeks ]

8.  Secondary:   Cumulative Rates of Moderate or Severe Chronic Obstructive Pulmonary Disease (COPD) Exacerbations for Multiple COPD Exacerbation at Different Time Points   [ Time Frame: 26, 52, 64, 76 weeks ]

9.  Secondary:   Pre-dose Forced Expiratory Volume in 1 Second (FEV-1) After 4, 12, 26, 38, 52 and 64 Weeks of Treatment Between QVA149, NVA237 and Open Label Tiotropium   [ Time Frame: 4, 12, 26, 38, 52 and 64 weeks ]

10.  Secondary:   Pre-dose Forced Vital Capacity (FVC)After 4, 12, 26, 38, 52 and 64 Weeks of Treatment Between QVA149, NVA237 and Open Label Tiotropium   [ Time Frame: 4, 12, 26, 38, 52 and 64 weeks ]

11.  Secondary:   Change in Mean Daily Use (Number of Puffs) of Rescue Therapy Between QVA149, NVA237 and Open Label Tiotropium From Baseling Over the 64 Week Treatment Period   [ Time Frame: Baseline (14 day run-in), 64 weeks ]

12.  Secondary:   Change From Baseline of Percentage of Days Without Rescue Therapy Use Between QVA149,NVA237 and Open Label Tiotropium Over the 64 Week Treatment Period   [ Time Frame: Baseline (14 day run-in), 64 weeks ]

13.  Secondary:   St. George's Respiratory Questionnaire (SGRQ) Scores Between QVA149, NVA237 and Open Label Tiotropium Over 12, 26, 38, 52 and 64 Weeks of Treatment   [ Time Frame: 12, 26, 38, 52 and 64 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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.


  More Information
  Hide More Information

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
e-mail: trialandresults.registries@novartis.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01120691     History of Changes
Other Study ID Numbers: CQVA149A2304
2009-013256-69 ( EudraCT Number )
First Submitted: May 5, 2010
First Posted: May 11, 2010
Results First Submitted: July 9, 2013
Results First Posted: September 30, 2013
Last Update Posted: December 2, 2013