We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT01202188
Previous Study | Return to List | Next Study

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:
ClinicalTrials.gov Identifier:
NCT01202188
First Posted: September 15, 2010
Last Update Posted: September 9, 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: February 7, 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 (COPD)
Interventions: Drug: indacaterol and glycopyrronium (QVA149)
Drug: glycopyrronium (NVA237)
Drug: indacaterol (QAB149)
Drug: tiotropium
Drug: placebo

  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
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
  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.
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 
Overall Participants Analyzed 
[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


  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


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

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01202188     History of Changes
Other Study ID Numbers: CQVA149A2303
2009-017772-25 ( EudraCT Number )
First Submitted: September 13, 2010
First Posted: September 15, 2010
Results First Submitted: February 7, 2013
Results First Posted: May 3, 2013
Last Update Posted: September 9, 2013