Text Size

A 24-Week Study to Evaluate the Safety and Efficacy of ADVAIR DISKUS 250/50mcg Plus SPIRIVA HANDIHALER Versus SPIRIVA HANDIHALER Plus Placebo DISKUS in Subjects With Chronic Obstructive Pulmonary Disease (COPD). SPIRIVA and HANDIHALER Are Trade Marks of Boehringer Ingelheim (ADC111114)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00784550
First received: October 31, 2008
Last updated: September 13, 2012
Last verified: September 2012
History of Changes
Results First Received: November 18, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: Tiotropium Bromide
Drug: FLuticasone Propionate/Salmeterol

  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
No text entered.

Reporting Groups
  Description
FSC + Tio Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
Tiotropium Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID

Participant Flow:   Overall Study
    FSC + Tio     Tiotropium  
STARTED     173     169  
COMPLETED     137     127  
NOT COMPLETED     36     42  
Adverse Event                 12                 10  
Lack of Efficacy                 0                 1  
Protocol Violation                 10                 10  
Lost to Follow-up                 8                 5  
Physician Decision                 2                 3  
Withdrawal by Subject                 4                 13  



  Baseline Characteristics
  Hide Baseline Characteristics

Reporting Groups
  Description
FSC + Tio Open-label tiotropium (Tio) 18 micrograms (mcg) once-daily (QD) plus double-blind Fluticasone Propionate/Salmeterol Combination (FSC) 250/50 mcg twice daily (BID)
Tiotropium Open-label Tio 18 mcg QD plus double-blind matching placebo DISKUS BID
Total Total of all reporting groups

Baseline Measures
    FSC + Tio     Tiotropium     Total  
Number of Participants  
[units: participants]
 		  173     169     342  
Age  
[units: Years]
Mean ± Standard Deviation 		  61.3  ± 8.56     61.0  ± 9.41     61.2  ± 8.98  
Gender  
[units: Participants]
 		     
Female     86     96     182  
Male     87     73     160  
Race/Ethnicity, Customized  
[units: participants]
 		     
White     165     162     327  
African American/African Heritage     7     7     14  
American Indian or Alaska Native     1     0     1  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Expiratory Volume in One Second (FEV1) at Endpoint   [ Time Frame: Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of AM pre-dose FEV1 for each participant) ]
  Show Outcome Measure 1

2.  Secondary:   Mean Change From Baseline in 2 Hour Post-dose FEV1 at Endpoint   [ Time Frame: Baseline and Endpoint (defined as the last recorded measure [taken up to Week 24] of 2 hour post-dose FEV1 for each participant) ]
  Show Outcome Measure 2

3.  Secondary:   Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-dose Forced Vital Capacity (FVC) at Endpoint   [ Time Frame: Baseline and Endpoint (defined as the last recorded measure [up to Week 24] of AM pre-dose FVC for each participant) ]
  Show Outcome Measure 3

4.  Secondary:   Mean Change From Baseline in 2 Hour Post-dose FVC at Endpoint   [ Time Frame: Baseline and Endpoint (defined as the last recorded measure of 2 hour post-dose FVC [up to Week 24] for each participant) ]
  Show Outcome Measure 4

5.  Secondary:   Mean Change From Baseline in AM (Morning, Approximately 6-9 AM) Pre-Dose Inspiratory Capacity (IC) at Endpoint   [ Time Frame: Baseline and Endpoint (defined as the last recorded measure of AM pre-dose IC [up to Week 24] for each participant) ]
  Show Outcome Measure 5

6.  Secondary:   Mean Change From Baseline in Scores on the Chronic Respiratory Disease Questionnaire-Self-Administered Standardized (CRQ-SAS) at Endpoint   [ Time Frame: Baseline and Endpoint (defined as the last recorded score [up to Week 24 or the early withdrawal visit] on each of the questions on this questionnaire) ]
  Show Outcome Measure 6


  Serious Adverse Events
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  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.


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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00784550     History of Changes
Other Study ID Numbers: 111114
Study First Received: October 31, 2008
Results First Received: November 18, 2010
Last Updated: September 13, 2012
Health Authority: United States: Food and Drug Administration