Trial record 1 of 1 for:    NCT01202188
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A Study to Assess the Efficacy, Safety and Tolerability of Once-daily (q.d.) QVA149 in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD) (SHINE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01202188
First received: September 13, 2010
Last updated: August 26, 2013
Last verified: August 2013
Results First Received: February 7, 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 (COPD)
Interventions: Drug: indacaterol and glycopyrronium (QVA149)
Drug: glycopyrronium (NVA237)
Drug: indacaterol (QAB149)
Drug: tiotropium
Drug: placebo

  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
There was a 14 day run-in period prior to randomization.

Reporting Groups
  Description
Indacaterol and Glycopyrronium (QVA149) QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
Indacaterol (QAB149) QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
Glycopyrronium (NVA237) NVA237 50 μg capsules for inhalation delivered once daily via a single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
Tiotropium Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
Placebo Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.

Participant Flow:   Overall Study
    Indacaterol and Glycopyrronium (QVA149)     Indacaterol (QAB149)     Glycopyrronium (NVA237)     Tiotropium     Placebo  
STARTED     475     477     475     483     234  
Safety Set; Received Study Drug     474     476     473     480     232  
COMPLETED     437     421     422     441     189  
NOT COMPLETED     38     56     53     42     45  
Protocol deviation                 14                 8                 12                 10                 11  
Subject withdrew consent                 12                 13                 22                 11                 13  
Adverse Event                 5                 23                 13                 10                 10  
Administrative problems                 3                 2                 1                 1                 2  
Unsatisfactory therapeutic effect                 2                 8                 2                 5                 8  
Lost to Follow-up                 1                 1                 0                 4                 1  
Death                 1                 1                 1                 1                 0  
Abnormal test procedure result (s)                 0                 0                 2                 0                 0  



  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.
Baseline measures are based on the Safety Set that includes all participants who received study drug.

Reporting Groups
  Description
Indacaterol and Glycopyrronium (QVA149) QVA149 110/50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
Indacaterol (QAB149) QAB149 150 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
Glycopyrronium (NVA237) NVA237 50 μg capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
Tiotropium Tiotropium 18 μg capsules for inhalation delivered once daily via HandiHaler® device for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
Placebo Matching Placebo capsules for inhalation delivered once daily via single-dose dry powder inhaler (SDDPI) for 26 weeks. Participants remained on a stable dose of inhaled corticosteroid (ICS) and salbutamol/albuterol was available for use as rescue medication throughout the study.
Total Total of all reporting groups

Baseline Measures
    Indacaterol and Glycopyrronium (QVA149)     Indacaterol (QAB149)     Glycopyrronium (NVA237)     Tiotropium     Placebo     Total  
Number of Participants  
[units: participants]
  474     476     473     480     232     2135  
Age  
[units: years]
Mean ± Standard Deviation
  64.0  ± 8.88     63.6  ± 8.78     64.3  ± 9.04     63.5  ± 8.73     64.4  ± 8.58     63.9  ± 8.83  
Gender  
[units: participants]
           
Female     112     122     108     120     63     525  
Male     362     354     365     360     169     1610  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment   [ Time Frame: 23 hours 15 minutes and 23 hour 45 minute post-dose Week 26 ]

2.  Secondary:   Transitional Dyspnea Index (TDI) Focal Score at Week 26   [ Time Frame: Week 26 ]

3.  Secondary:   St. George’s Respiratory Questionnaire (SGRQ) Total Score at Week 26   [ Time Frame: 26 weeks ]

4.  Secondary:   Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication Over 26 Weeks   [ Time Frame: Baseline, Week 26 ]

5.  Secondary:   Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment With QVA149, QAB149 and NVA237 Compared to Placebo   [ Time Frame: 23 hours 15 minutes and 23 hour 45 minute post-dose Week 26 ]

6.  Secondary:   Trough Forced Expiratory Volume In One Second (FEV1) After 26 Weeks of Treatment With QVA149 Compared to Tiotropium   [ Time Frame: 23 hours 15 minutes and 23 hour 45 minute post-dose Week 26 ]

7.  Secondary:   Baseline Transitional Dyspnea Index (BDI/TDI) Focal Score at Week 12 and Week 26   [ Time Frame: Baseline, Week 12, Week 26 ]

8.  Secondary:   Percentage of Patients With a Clinically Important Improvement of at Least 1 Point in TDI Focal Score After 26 Weeks of Treatment   [ Time Frame: Baseline, Week 26 ]

9.  Secondary:   St. George's Respiratory Questionnaire (SGRQ) Total Score After 12 and 26 Weeks of Treatment   [ Time Frame: Week 12, Week 26 ]

10.  Secondary:   Percentage of Patients With a Clinically Important Improvement From Baseline of at Least 4 Units in the SGRQ Total Score After 26 Weeks of Treatment   [ Time Frame: Baseline, Week 26 ]

11.  Secondary:   Percentage of Nights With "No Night Time Awakenings" Over 26 Weeks   [ Time Frame: 26 Weeks ]

12.  Secondary:   Percentage of Days With "No Daytime Symptoms" Over 26 Weeks   [ Time Frame: 26 Weeks ]

13.  Secondary:   Percentage of "Days Able to Perform Usual Daily Activities" Over 26 Weeks   [ Time Frame: 26 Weeks ]

14.  Secondary:   Change From Baseline in the Mean Daily Number of Puffs of Rescue Medication at Week 12 and Week 26   [ Time Frame: Baseline, Week 12, Week 26 ]

15.  Secondary:   Change From Baseline (BL) in the Daytime and Night Time Rescue Medication Use (Number of Puffs) Over 26 Weeks   [ Time Frame: Baseline, Week 26 ]

16.  Secondary:   Percentage of "Days With no Rescue Medication Use" Over 26 Weeks   [ Time Frame: 26 Weeks ]

17.  Secondary:   Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 4 Hours at Day 1 and Week 26   [ Time Frame: From 5 minutes to 4 hours post-dose Day 1 and Week 26 ]

18.  Secondary:   Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 12 Hours at Day 1 and Week 26   [ Time Frame: From 5 minutes to 12 hours post-dose Day 1 and Week 26 ]

19.  Secondary:   Standardized FEV1 (With Respect to Length of Time) Area Under the Curve (AUC) From 5 Minutes to 23 Hours 45 Minutes at Week 26   [ Time Frame: From 5 minutes to 23 hours 45 minutes post-dose Week 26 ]

20.  Secondary:   24 Hour Holter Monitoring in a Subset of Patients   [ Time Frame: Week 12, Week 26 ]

21.  Secondary:   Rate of Moderate or Severe COPD Exacerbation   [ Time Frame: 26 Weeks ]

22.  Secondary:   Percentage of Patients With at Least One Moderate or Severe COPD Exacerbation Over the 26 Week Treatment Period   [ Time Frame: 26 Weeks ]

23.  Secondary:   Percentage of Participants With COPD Exacerbations Requiring Hospitalization or Treatment With Systemic Corticosteroids and/or Antibiotics But no Hospitalization   [ Time Frame: 26 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


No publications provided


Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01202188     History of Changes
Other Study ID Numbers: CQVA149A2303, 2009-017772-25
Study First Received: September 13, 2010
Results First Received: February 7, 2013
Last Updated: August 26, 2013
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Argentina: Human Research Bioethics Committee
Argentina: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council
Bulgaria: Bulgarian Drug Agency
Bulgaria: Ministry of Health
Canada: Health Canada
China: Food and Drug Administration
Finland: Ethics Committee
Finland: Ministry of Social Affairs and Health
Finland: Finnish Medicines Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Direction Générale de la Santé
France: French Data Protection Authority
France: Haute Autorité de Santé Transparency Commission
France: Institutional Ethical Committee
France: Ministry of Health
France: National Consultative Ethics Committee for Health and Life Sciences
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Germany: Federal Ministry of Education and Research
Germany: Federal Ministry of Food, Agriculture and Consumer Protection
Germany: German Institute of Medical Documentation and Information
Germany: Ministry of Health
Germany: Paul-Ehrlich-Institut
Guatemala: MSPAS - Ministerio de Salud Pública y Asistencia Social: Programa Nacional de Farmacovigilancia
Hungary: Research Ethics Medical Committee
Hungary: National Institute of Pharmacy
India: Central Drugs Standard Control Organization
India: Department of Atomic Energy
India: Drugs Controller General of India
India: Indian Council of Medical Research
India: Institutional Review Board
India: Ministry of Health
India: Ministry of Science and Technology
India: Science and Engineering Research Council
Japan: Ministry of Health, Labor and Welfare
Mexico: Ethics Committee
Mexico: Federal Commission for Protection Against Health Risks
Mexico: Federal Commission for Sanitary Risks Protection
Mexico: Ministry of Health
Mexico: National Council of Science and Technology
Mexico: National Institute of Public Health, Health Secretariat
Netherlands: Independent Ethics Committee
Netherlands: Dutch Health Care Inspectorate
Netherlands: Medical Ethics Review Committee (METC)
Netherlands: Medicines Evaluation Board (MEB)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Panama: Ministry of Health
Philippines: Department of Health
Philippines: Bureau of Food and Drugs
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Ministry of Health
Poland: Ministry of Science and Higher Education