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
  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
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
  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.
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  
Number of Participants  
[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
  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: 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: 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