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Influence Of Salmeterol Xinafoate/Fluticasone Propionate (50/500 µg BID) On The Course Of The Disease And Exacerbation Frequency In COPD Patients Gold Stage III And IV

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00527826
First received: September 10, 2007
Last updated: October 25, 2012
Last verified: October 2012
History of Changes
Results First Received: March 10, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Pulmonary Disease, Chronic Obstructive
Interventions: Drug: Salmeterol / Fluticasone (50/500 µg) BID fixed combination
Drug: Salmeterol / Fluticasone (50/500 µg) BID separate Inhalers

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)

Participant Flow:   Overall Study
    Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg     Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg  
STARTED     108 [1]   106  
COMPLETED     87     80  
NOT COMPLETED     21     26  
Adverse Event                 10                 10  
Lost to Follow-up                 3                 2  
Withdrawal by Subject                 5                 8  
Inclusion Criteria Not Met                 3                 3  
Alpha-1 Antitrypsin Deficiency                 0                 1  
Additional Intake of Viani forte                 0                 1  
Participant moved away                 0                 1  
[1] All Patients Population was used for Participant Flow section.



  Baseline Characteristics
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Reporting Groups
  Description
Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg Salmeterol xinafoate/fluticasone propionate (FP) 50/500 µg twice a day (BID) (morning and evening) from the fixed combination inhaler (VIANI forte Diskus)
Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg Salmeterol xinafoate (Sal)/fluticasone propionate (FP) 50/500 µg BID (morning and evening) from two separate inhalers (SEREVENT Diskus and FLUTIDE forte Diskus)
Total Total of all reporting groups

Baseline Measures
    Salmeterol Xinafoate/FP in Fixed Combination (SFC) 50/500 µg     Salmeterol Xinafoate/FP Separately (Sal/FP) 50/500 µg     Total  
Number of Participants  
[units: participants]
 		  107     105     212  
Age [1]
[units: years]
Mean ± Standard Deviation 		  65.6  ± 8.3     64.2  ± 8.9     64.9  ± 8.6  
Gender [2]
[units: participants]
 		     
Female     33     29     62  
Male     74     76     150  
Severity of Chronic Obstructive Lung Disease (COPD) [3]
[units: participants]
 		     
Severe COPD     77     79     156  
Very severe COPD     30     26     56  
Smoking History [4]
[units: participants]
 		     
Ex-smoker     74     78     152  
Smoker     33     27     60  
[1] Age at study start (years). The Intent-to-Treat (ITT) Population (all participants receiving at least one dose of study medication and suffering from COPD) was used for all baseline characteristics.
[2] The ITT Population was used.
[3] Severe COPD (stage III) is defined by the global initiative for chronic obstructive lung disease (GOLD) as baseline forced expiratory volume in one second (FEV1) >30% and <50% predicted and FEV1/inspiratory vital capacity (IVC) ratio <70%. Very severe COPD (stage IV) is defined as baseline FEV1 <30% predicted and FEV1/IVC <70%. ITT Population.
[4] The number of smokers/ex-smokers participating in the study was recorded. The ITT Population was used.



  Outcome Measures
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1.  Primary:   Mean Number of Exacerbations Per Year: Negative Binomial Model   [ Time Frame: Baseline through Week 52 ]
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2.  Primary:   Mean Number of Exacerbations Per Year: Poisson Model   [ Time Frame: Baseline through Week 52 ]
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3.  Secondary:   Compliance and Adherence to Study Medication   [ Time Frame: Baseline through Week 52 ]
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4.  Secondary:   Mean Number of COPD-related Visits at/by Physician   [ Time Frame: Baseline through Week 52 ]
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5.  Secondary:   Number of Participants With the Indicated Number of Days at the Intensive Care Unit (ICU)   [ Time Frame: Baseline through Week 52 ]
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6.  Secondary:   Number of Participants With the Indicated Number of Hospital Stays   [ Time Frame: Baseline through Week 52 ]
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7.  Secondary:   Mean Number of Days Rescue Medication Was Used   [ Time Frame: The 7 days before baseline (=Visit 2 [Week 8]) and the last 7 days of study (=Visit 6 [Week 52]) ]
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8.  Secondary:   Mean Change From Baseline in Forced Expiratory Volume in 1 Second (FEV1) at Week 52   [ Time Frame: Baseline and Week 52 ]
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9.  Secondary:   Mean Change From Baseline in Inspiratory Vital Capacity (IVC) at Week 52   [ Time Frame: Baseline and Week 52 ]
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10.  Secondary:   Mean Change From Baseline in the Tiffeaneau Index at Week 52   [ Time Frame: Baseline and Week 52 ]
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11.  Secondary:   Mean Change From Baseline in the Symptom Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52   [ Time Frame: Baseline and Week 52 ]
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12.  Secondary:   Mean Change From Baseline in the Activity Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52   [ Time Frame: Baseline and Week 52 ]
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13.  Secondary:   Mean Change From Baseline in the Impact Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52   [ Time Frame: Baseline and Week 52 ]
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14.  Secondary:   Mean Change From Baseline in the Total Score of the St. George's Respiratory Questionnaire (SGRQ) at Week 52   [ Time Frame: Baseline and Week 52 ]
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15.  Secondary:   Mean Total Costs (Related to COPD) Per Participant   [ Time Frame: Baseline through Week 52 ]
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  Serious Adverse Events
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  Other Adverse Events
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  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
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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: NCT00527826     History of Changes
Other Study ID Numbers: SCO107227
Study First Received: September 10, 2007
Results First Received: March 10, 2010
Last Updated: October 25, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices