ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
ClinicalTrials.gov Identifier: NCT00603382
Recruitment Status : Completed
First Posted : January 29, 2008
Results First Posted : August 19, 2013
Last Update Posted : April 18, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: GW685698X
Drug: Placebo

  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
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. Total 1459 par. were screened, 601 were randomized of which 598 par. received at least one dose of study treatment.

Reporting Groups
  Description
Placebo Participants received placebo once daily (OD) in the evening from the dry powder inhaler (DPI) 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 25 µg OD Participants received GW685698X 25 micrograms (µg) OD in the evening from the DPI 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 50 µg OD Participants received GW685698X 50 µg OD in the evening from the DPI 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 100 µg OD Participants received GW685698X 100 µg OD in the evening from the DPI 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 DPI 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 100 µg BID Participants received fluticasone propionate (FP) 100 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 DPI 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 25 µg OD   GW685698X 50 µg OD   GW685698X 100 µg OD   GW685698X 200 µg OD   FP 100 µg BID
STARTED   94   97   100   110   95   102 
COMPLETED   76   83   91   98   86   84 
NOT COMPLETED   18   14   9   12   9   18 
Adverse Event                0                1                1                2                1                2 
Lack of Efficacy                14                9                3                6                6                11 
Protocol Violation                1                0                1                2                1                0 
Lost to Follow-up                0                1                1                1                0                1 
Physician Decision                0                0                2                0                1                3 
Withdrawal by Subject                3                3                1                1                0                1 



  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.
No text entered.

Reporting Groups
  Description
Placebo Participants received placebo OD in the evening from the DPI 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 25 µg OD Participants received GW685698X 25 µg OD in the evening from the DPI 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 50 µg OD Participants received GW685698X 50 µg OD in the evening from the DPI 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 100 µg OD Participants received GW685698X 100 µg OD in the evening from the DPI 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 DPI 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 100 µg BID Participants received FP 100 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 DPI 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 25 µg OD   GW685698X 50 µg OD   GW685698X 100 µg OD   GW685698X 200 µg OD   FP 100 µg BID   Total 
Overall Participants Analyzed 
[Units: Participants]
 94   97   100   110   95   102   598 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.2  (15.82)   37.7  (15.40)   38.3  (14.49)   36.8  (15.56)   40.7  (15.96)   39.9  (15.03)   38.7  (15.37) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
             
Female      47  50.0%      57  58.8%      59  59.0%      60  54.5%      60  63.2%      56  54.9%      339  56.7% 
Male      47  50.0%      40  41.2%      41  41.0%      50  45.5%      35  36.8%      46  45.1%      259  43.3% 
Race/Ethnicity, Customized 
[Units: Participants]
             
African American/African Heritage (AA/AHER)   5   4   4   8   6   5   32 
American Indian or Alaska Native   5   7   5   6   6   5   34 
Asian   7   13   9   10   10   10   59 
White   69   64   72   76   64   74   419 
AA/AHER & American Indian or Alaska Native   0   0   0   0   1   0   1 
American Indian or Alaska Native & White   8   8   9   10   8   8   51 
Native Hawaiian or other Pacific Islander & White   0   1   1   0   0   0   2 


  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 Creatinine, Direct Bilirubin, Total Bilirubin, and Uric Acid 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: 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

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

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: NCT00603382     History of Changes
Other Study ID Numbers: FFA109687
First Submitted: December 27, 2007
First Posted: January 29, 2008
Results First Submitted: June 6, 2013
Results First Posted: August 19, 2013
Last Update Posted: April 18, 2018