Trial record 1 of 1 for:    NCT01120691.
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Effect of QVA149 Versus NVA237 and Tiotropium on Chronic Obstructive Pulmonary Disorder (COPD) Exacerbations (SPARK)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01120691
First received: May 5, 2010
Last updated: October 29, 2013
Last verified: October 2013
Results First Received: July 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Chronic Obstructive Pulmonary Disease
Interventions: Drug: QVA149
Drug: NVA237
Drug: tiotropium
Drug: Salbutamol/albuterol

  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
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
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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.
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  
Number of Participants  
[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


  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 by Novartis

Publications automatically indexed to this study:

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01120691     History of Changes
Other Study ID Numbers: CQVA149A2304, 2009-013256-69
Study First Received: May 5, 2010
Results First Received: July 9, 2013
Last Updated: October 29, 2013
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Australia: Department of Health and Ageing Therapeutic Goods Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Canada: Health Canada
Chile: Comisión Nacional de Investigación Científica y Tecnológica
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Estonia: The State Agency of Medicine
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Greece: National Organization of Medicines
Guatemala: Ministry of Public Health and Social Assistance
Hungary: National Institute of Pharmacy
India: Drugs Controller General of India
Ireland: Irish Medicines Board
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Korea: Food and Drug Administration
Malaysia: Ministry of Health
Mexico: Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
New Zealand: Food Safety Authority
Norway: Norwegian Medicines Agency
Peru: Ministry of Health
Philippines: Bureau of Food and Drugs
Poland: Ministry of Health
Romania: National Medicines Agency
Russia: Ministry of Health of the Russian Federation
Singapore: Health Sciences Authority
South Africa: Department of Health
Spain: Spanish Agency of Medicines
Thailand: Food and Drug Administration
Turkey: Ministry of Health
Ukraine: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency