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A Randomized Study To Evaluate The Efficacy And Safety Of An Investigational Drug In Adolescent And Adult Subjects With Asthma Uncontrolled on Low-Dose ICS Therapy.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00603278
First received: December 27, 2007
Last updated: June 6, 2013
Last verified: May 2011
Results First Received: June 6, 2013  
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: Asthma
Interventions: Drug: GW685698X
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
Participants (par.) meeting eligibility criteria at the Screening visit completed a 28-day Run-in Period for Baseline safety evaluations and measures of asthma status. Par. were then randomized to an 8-week Treatment Period. 1406 par. were screened, and 622 par. were randomized, out of which 615 par. received at least one dose of study treatment.

Reporting Groups
  Description
Placebo Participants received placebo once daily (OD) in the evening from the novel dry powder inhaler (NDPI) and placebo twice daily (BID) from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
GW685698X 100 µg OD Participants received GW685698X 100 micrograms (µg) OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
GW685698X 200 µg OD Participants received GW685698X 200 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
GW685698X 300 µg OD Participants received GW685698X 300 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
GW685698X 400 µg OD Participants received GW685698X 400 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
FP 250 µg BID Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the NDPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.

Participant Flow:   Overall Study
    Placebo   GW685698X 100 µg OD   GW685698X 200 µg OD   GW685698X 300 µg OD   GW685698X 400 µg OD   FP 250 µg BID
STARTED   107   105   101   103   99   100 
COMPLETED   66   88   87   92   86   81 
NOT COMPLETED   41   17   14   11   13   19 
Lack of Efficacy                35                10                11                8                7                14 
Adverse Event                0                3                1                0                2                1 
Withdrawal by Subject                2                3                1                2                1                2 
Protocol Violation                3                0                1                1                0                1 
Physician Decision                0                1                0                0                2                1 
Lost to Follow-up                1                0                0                0                1                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.
No text entered.

Reporting Groups
  Description
Placebo Participants received placebo once daily OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol inhalation aerosol to be used as needed throughout the study.
GW685698X 100 µg OD Participants received GW685698X 100 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
GW685698X 200 µg OD Participants received GW685698X 200 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
GW685698X 300 µg OD Participants received GW685698X 300 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
GW685698X 400 µg OD Participants received GW685698X 400 µg OD in the evening from the NDPI and placebo BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
FP 250 µg BID Participants received fluticasone propionate (FP) 250 µg BID from the DISKUS/ACCUHALER (one inhalation in the morning and one inhalation in the evening) plus placebo OD in the evening from the NDPI for 8 weeks. In addition, participants were provided supplemental albuterol/salbutamol aerosol to be used as needed throughout the study.
Total Total of all reporting groups

Baseline Measures
   Placebo   GW685698X 100 µg OD   GW685698X 200 µg OD   GW685698X 300 µg OD   GW685698X 400 µg OD   FP 250 µg BID   Total 
Overall Participants Analyzed 
[Units: Participants]
 107   105   101   103   99   100   615 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.1  (16.19)   38.3  (16.76)   38.8  (15.97)   39.9  (15.57)   40.7  (15.87)   39.8  (16.70)   39.4  (16.14) 
Gender 
[Units: Participants]
             
Female   74   72   63   67   64   62   402 
Male   33   33   38   36   35   38   213 
Race/Ethnicity, Customized 
[Units: Participants]
             
White   62   64   65   63   56   61   371 
Central/South Asian Heritage (HER)   1   1   0   1   0   0   3 
Japanese/East Asian HER/South East Asian HER   25   24   23   22   25   23   142 
American Indian or Alaska Native   0   1   0   0   0   0   1 
American Indian or Alaska Native & White   14   12   13   14   13   13   79 
African American/African HER   5   2   0   2   4   3   16 
African American/African Heritage & White   0   1   0   0   0   0   1 
Native Hawaiian or other Pacific Islander   0   0   0   0   1   0   1 
Missing   0   0   0   1   0   0   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Change From Baseline in Trough (Evening Pre-dose and Pre- Rescue Bronchodilator) FEV1 at Week 8   [ Time Frame: Baseline and Week 8 ]

2.  Secondary:   Mean Change From Baseline in Daily Trough (Pre-dose and Pre-rescue Bronchodilator) Evening Peak Expiratory Flow (PEF) Averaged Over the 8-week Treatment Period   [ Time Frame: From Baseline up to Week 8 ]

3.  Secondary:   Mean Change From Baseline in Daily Morning PEF Averaged Over the 8-week Treatment Period   [ Time Frame: From Baseline up to Week 8 ]

4.  Secondary:   Mean Change From Baseline in the Percentage of Symptom-free 24-hour (hr) Periods During the 8-week Treatment Period   [ Time Frame: From Baseline up to Week 8 ]

5.  Secondary:   Mean Change From Baseline in the Percentage of Rescue Free 24-hour (hr) Periods During the 8-week Treatment Period   [ Time Frame: From Baseline up to Week 8 ]

6.  Secondary:   Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period   [ Time Frame: From the first dose of study medication up to Week 8/Early Withdrawal ]

7.  Secondary:   Number of Participants With Any On-treatment Adverse Events or Serious Adverse Events Throughout the 8-week Treatment Period   [ Time Frame: From the first dose of study medication up to Week 8/Early Withdrawal ]

8.  Secondary:   Number of Participants With Clinical/Visual Evidence of Oropharyngeal Candidiasis   [ Time Frame: From Baseline up to Week 8/Early Withdrawal ]

9.  Secondary:   Percentage of Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils in the Blood at Baseline and Week 8   [ Time Frame: Baseline and Week 8 ]

10.  Secondary:   Hematocrit at Baseline and Week 8   [ Time Frame: Baseline and Week 8 ]

11.  Secondary:   Hemoglobin at Baseline and Week 8   [ Time Frame: Baseline and Week 8 ]

12.  Secondary:   Platelet Count and White Blood Cell (WBC) Count at Baseline and Week 8   [ Time Frame: Baseline and Week 8 ]

13.  Secondary:   Red Blood Cells (RBC) Count at Baseline and Week 8   [ Time Frame: Baseline and Week 8 ]

14.  Secondary:   Clinical Chemistry Parameters of Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Lactate Dehydrogenase (LD), and Gamma Glutamyltransferase (GGT) at Baseline and Week 8   [ Time Frame: Baseline and Week 8 ]

15.  Secondary:   Clinical Chemistry Parameters of Albumin and Total Protein at Baseline and Week 8   [ Time Frame: Baseline and Week 8 ]

16.  Secondary:   Clinical Chemistry Parameters of Chloride, Calcium, Carbon Dioxide Content/Bicarbonate (CO2/BI), Cholesterol, Glucose, Phosphorus Inorganic(PI), Potassium, Sodium, and Urea/Blood Urea Nitrogen (BUN) at Baseline and Week 8   [ Time Frame: Baseline and Week 8 ]

17.  Secondary:   Clinical Chemistry Parameters of Direct Bilirubin (DBIL), Total Bilirubin (TBIL), Uric Acid and Creatinine at Baseline and Week 8   [ Time Frame: Baseline and Week 8 ]

18.  Secondary:   Number of Participants With the Indicated Result for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline and Week 8/Early Withdrawal   [ Time Frame: Baseline and Week 8/Early Withdrawal ]

19.  Secondary:   Urine Specific Gravity at Baseline and Week 8/Early Withdrawal   [ Time Frame: Urine specific gravity at Baseline and Week 8/Early Withdrawal ]

20.  Secondary:   Urine pH at Baseline and Week 8/Early Withdrawal   [ Time Frame: Baseline and Week 8/Early Withdrawal ]

21.  Secondary:   24-hour Urinary Cortisol Excretion at Baseline and Week 8   [ Time Frame: Baseline and Week 8 ]

22.  Secondary:   Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Week 8   [ Time Frame: Baseline and Week 8 ]

23.  Secondary:   Change From Baseline in Heart Rate at Week 8   [ Time Frame: Baseline and Week 8 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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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  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.


Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00603278     History of Changes
Other Study ID Numbers: FFA109685
Study First Received: December 27, 2007
Results First Received: June 6, 2013
Last Updated: June 6, 2013
Health Authority: United States: Food and Drug Administration