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A Clinical Trial to Test a Study Drug in Volunteers Who Develop Asthma Following Exercise

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00812929
First Posted: December 22, 2008
Last Update Posted: September 19, 2017
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.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: July 10, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Asthma
Interventions: Drug: Placebo
Drug: GSK2190915

  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
This was a Phase IIa multi-center study conducted in the United States from 02 December 2008 to 15 July 2009.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 47 participants were randomized in the study who underwent a screening visit of 28 days prior to first dose of study medication.

Reporting Groups
  Description
P/A/D/B/C In this sequence participants received treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 1, treatment A of oral single dose of aqueous solution of 10 milligrams (mg) GSK2190915 on Day 1 of treatment period 2, treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 3, treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 4 and treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
A/B/P/C/D In this sequence participants received treatment A of oral single dose of aqueous solution of 10 mg GSK2190915 on Day 1 of treatment period 1, treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 2, treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 3, treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 4 and treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
B/C/A/D/P In this sequence participants received treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 1, treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 2, treatment A of oral single dose of aqueous solution of 10 mg GSK2190915 on Day 1 of treatment period 3, treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 4, treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
C/D/B/P/A In this sequence participants received treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 1, treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 2, treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 3, treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 4, treatment A of oral single dose of aqueous solution of 10 mg GSK2190915 on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
D/P/C/A/B In this sequence participants received treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 1, treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 2, treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 3, treatment A of oral single dose of aqueous solution of 10 mg GSK2190915 on Day 1 of treatment period 4, treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
C/B/D/A/P In this sequence participants received treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 1, treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 2, treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 3, treatment A of oral single dose of aqueous solution of 10 mg GSK2190915 on Day 1 of treatment period 4, treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
D/C/P/B/A In this sequence participants received treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 1, treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 2, treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 3, treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 4, treatment A of oral single dose of aqueous solution of 10 mg GSK2190915 on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
P/D/A/C/B In this sequence participants received treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 1, treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 2, treatment A of oral single dose of aqueous solution of 10 mg GSK2190915 on Day 1 of treatment period 3, treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 4, treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
A/P/B/D/C In this sequence participants received treatment A of oral single dose of aqueous solution of 10 mg GSK2190915 on Day 1 of treatment period 1, treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 2, treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 3, treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 4, treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.
B/A/C/P/D In this sequence participants received treatment B of oral single dose of aqueous solution of 50 mg GSK2190915 on Day 1 of treatment period 1, treatment A of oral single dose of aqueous solution of 10 mg GSK2190915 on Day 1 of treatment period 2, treatment C of oral single dose of aqueous solution of 100 mg GSK2190915 on Day 1 of treatment period 3, treatment P of oral single dose of aqueous solution of matching placebo on Day 1 of treatment period 4, treatment D of oral single dose of aqueous solution of 200 mg GSK2190915 on Day 1 of treatment period 5. Each treatment periods were separated by a minimum 7 days washout period. Each treatment period included an exercise challenge at 2, 9.5, and 24 hours post dose and concluded on completion of the assessments following exercise challenge at 24 hours post dose.

Participant Flow for 9 periods

Period 1:   Treatment Period 1
    P/A/D/B/C   A/B/P/C/D   B/C/A/D/P   C/D/B/P/A   D/P/C/A/B   C/B/D/A/P   D/C/P/B/A   P/D/A/C/B   A/P/B/D/C   B/A/C/P/D
STARTED   5   4   5   4   5   5   5   5   4   5 
COMPLETED   5   4   5   4   5   5   5   5   4   5 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0 

Period 2:   Washout Period 1 (7 Days)
    P/A/D/B/C   A/B/P/C/D   B/C/A/D/P   C/D/B/P/A   D/P/C/A/B   C/B/D/A/P   D/C/P/B/A   P/D/A/C/B   A/P/B/D/C   B/A/C/P/D
STARTED   5   4   5   4   5   5   5   5   4   5 
COMPLETED   5   4   4   4   5   5   5   5   4   5 
NOT COMPLETED   0   0   1   0   0   0   0   0   0   0 
Physician Decision                0                0                1                0                0                0                0                0                0                0 

Period 3:   Treatment Period 2
    P/A/D/B/C   A/B/P/C/D   B/C/A/D/P   C/D/B/P/A   D/P/C/A/B   C/B/D/A/P   D/C/P/B/A   P/D/A/C/B   A/P/B/D/C   B/A/C/P/D
STARTED   5   4   4   4   5   5   5   5   4   5 
COMPLETED   5   4   4   4   5   5   5   5   4   5 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0 

Period 4:   Washout Period 2 (7 Days)
    P/A/D/B/C   A/B/P/C/D   B/C/A/D/P   C/D/B/P/A   D/P/C/A/B   C/B/D/A/P   D/C/P/B/A   P/D/A/C/B   A/P/B/D/C   B/A/C/P/D
STARTED   5   4   4   4   5   5   5   5   4   5 
COMPLETED   5   4   4   4   5   5   5   5   4   4 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   1 
Physician Decision                0                0                0                0                0                0                0                0                0                1 

Period 5:   Treatment Period 3
    P/A/D/B/C   A/B/P/C/D   B/C/A/D/P   C/D/B/P/A   D/P/C/A/B   C/B/D/A/P   D/C/P/B/A   P/D/A/C/B   A/P/B/D/C   B/A/C/P/D
STARTED   5   4   4   4   5   5   5   5   4   4 
COMPLETED   5   4   4   4   5   5   5   5   4   4 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0 

Period 6:   Washout Period 3 (7 Days)
    P/A/D/B/C   A/B/P/C/D   B/C/A/D/P   C/D/B/P/A   D/P/C/A/B   C/B/D/A/P   D/C/P/B/A   P/D/A/C/B   A/P/B/D/C   B/A/C/P/D
STARTED   5   4   4   4   5   5   5   5   4   4 
COMPLETED   5   4   4   4   5   4   5   5   4   4 
NOT COMPLETED   0   0   0   0   0   1   0   0   0   0 
Adverse Event                0                0                0                0                0                1                0                0                0                0 

Period 7:   Treatment Period 4
    P/A/D/B/C   A/B/P/C/D   B/C/A/D/P   C/D/B/P/A   D/P/C/A/B   C/B/D/A/P   D/C/P/B/A   P/D/A/C/B   A/P/B/D/C   B/A/C/P/D
STARTED   5   4   4   4   5   4   5   5   4   4 
COMPLETED   5   4   4   4   5   4   5   5   4   4 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0 

Period 8:   Washout Period 4 (7 Days)
    P/A/D/B/C   A/B/P/C/D   B/C/A/D/P   C/D/B/P/A   D/P/C/A/B   C/B/D/A/P   D/C/P/B/A   P/D/A/C/B   A/P/B/D/C   B/A/C/P/D
STARTED   5   4   4   4   5   4   5   5   4   4 
COMPLETED   5   4   4   4   5   4   5   5   4   4 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0 

Period 9:   Treatment Period 5
    P/A/D/B/C   A/B/P/C/D   B/C/A/D/P   C/D/B/P/A   D/P/C/A/B   C/B/D/A/P   D/C/P/B/A   P/D/A/C/B   A/P/B/D/C   B/A/C/P/D
STARTED   5   4   4   4   5   4   5   5   4   4 
COMPLETED   5   4   4   4   5   4   5   5   4   4 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   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
Total Eligible participants completed five treatment periods (single dose 10 mg, 50 mg, 100 mg, 200 mg GSK2190915 oral solution, compared to placebo control which was administered on Day 1 of each treatment period). Each treatment period lasted 2 days, with a minimum 7 day washout period between each treatment periods.

Baseline Measures
   Total 
Overall Participants Analyzed 
[Units: Participants]
 47 
Age 
[Units: Years]
Mean (Standard Deviation)
 28.4  (8.57) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      6  12.8% 
Male      41  87.2% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
American Indian or Alaska Native      0   0.0% 
Asian      3   6.4% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      6  12.8% 
White      38  80.9% 
More than one race      0   0.0% 
Unknown or Not Reported      0   0.0% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Maximal Percentage Change From Pre-exercise Baseline Forced Expiratory Volume in 1 Second (FEV1) to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 24 Hours Post Dose   [ Time Frame: Baseline (pre dose) and 60 minutes following the exercise challenge at 24 hours post dose of each treatment period. ]

2.  Secondary:   Maximal Percentage Change From Pre-exercise Baseline FEV1 to the Minimum FEV1 Collected Within 60 Minutes Following the Exercise Challenge at 2 and 9.5 Hours Post Dose   [ Time Frame: Baseline (pre dose) and 60 minutes following the exercise challenge at 2 and 9.5 hours post dose of each treatment period. ]

3.  Secondary:   Weighted Mean (WM) for FEV1 Percentage Change From Baseline Recorded During 0 to 60 Minutes Following Exercise Challenge (FEV1 WM0-60)   [ Time Frame: Baseline (pre dose) and 0 to 60 minutes following exercise challenge at 2, 9.5 and 24 hours post dose of each treatment period. ]

4.  Secondary:   Time to FEV1 Recovery to Within 5 Percent of Baseline Following Exercise Challenge   [ Time Frame: 0 to 60 minutes following exercise challenge at 2, 9.5 and 24 hours post dose of each treatment period ]

5.  Secondary:   Number of Participants Using a Short Acting Beta-2 Agonist (Rescue Medication) During 0 to 90 Minutes Following Exercise Challenge   [ Time Frame: 0 to 90 minutes following exercise challenge of each treatment period ]

6.  Secondary:   Assessment of Vital Signs: Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)   [ Time Frame: Pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge of treatment period ]

7.  Secondary:   Assessment of Vital Signs: Heart Rate (HR)   [ Time Frame: Pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge of each treatment period ]

8.  Secondary:   Number of Participants With Abnormal Electrocardiogram (ECG) Findings   [ Time Frame: Pre dose, 2 hours, 9.5 hours and 24 hours prior to exercise challenge and 60 minutes following exercise challenge at 2 hours of each treatment period ]

9.  Secondary:   Assessment of Clinical Chemistry Parameters: Albumin, Total Protein   [ Time Frame: Pre dose and 25 hours and 30 minutes post dose of each treatment period ]

10.  Secondary:   Assessment of Clinical Chemistry Parameters: Alkaline Phosphatase (ALP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Gamma Glutamyl Transferase (GGT)   [ Time Frame: Pre dose and 25 hours and 30 minutes post dose of each treatment period ]

11.  Secondary:   Assessment of Clinical Chemistry Parameters: Direct Bilirubin, Total Bilirubin, Creatinine   [ Time Frame: Pre dose and 25 hours and 30 minutes post dose of each treatment period ]

12.  Secondary:   Assessment of Clinical Chemistry Parameters: Calcium, Chloride, Glucose, Potassium, Sodium, Urea/Blood Urea Nitrogen (BUN)   [ Time Frame: Pre dose and 25 hours and 30 minutes post dose of each treatment period ]

13.  Secondary:   Assessment of Hematology Parameters: Basophils, Eosinophils, Lymphocytes, Monocytes, Total Neutrophils (TN) (ANC - Absolute Neutrophil Count), Platelet Count, White Blood Cell Count (WBC)   [ Time Frame: Pre dose and 25 hours and 30 minutes post dose of each treatment period ]

14.  Secondary:   Assessment of Hematology Parameters: Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC)   [ Time Frame: Pre dose and 25 hours and 30 minutes post dose of each treatment period ]

15.  Secondary:   Assessment of Hematology Parameters: Hematocrit   [ Time Frame: Pre dose and 25 hours and 30 minutes post dose of each treatment period ]

16.  Secondary:   Assessment of Hematology Parameters: Mean Corpuscle Hemoglobin (MCH)   [ Time Frame: Pre dose and 25 hours and 30 minutes post dose of each treatment period ]

17.  Secondary:   Assessment of Hematology Parameters: Mean Corpuscle Volume (MCV)   [ Time Frame: Pre dose and 25 hours and 30 minutes post dose of each treatment period ]

18.  Secondary:   Assessment of Hematology Parameters: Red Blood Cell Count (RBC)   [ Time Frame: Pre dose and 25 hours and 30 minutes post dose of each treatment period ]

19.  Secondary:   Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)   [ Time Frame: Up to follow up (7 to 21 days) following last dose ]

20.  Secondary:   Percentage Change From Baseline in Blood Leukotriene B4 (LTB4)   [ Time Frame: Baseline (pre dose) up to 24 Hours post dose of each treatment period ]

21.  Secondary:   Percentage Change From Baseline in Urine Leukotriene E4 (LTE4)   [ Time Frame: Baseline (pre dose) up to 24 Hours post dose of each treatment period ]

22.  Secondary:   Derived Pharmacokinetic (PK) Parameters for GSK2190915   [ Time Frame: Pre dose, 2 hours, 3.5 hours, 9.5 hours, 11 hours and 24 hours following exercise challenge of each treatment period ]


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00812929     History of Changes
Other Study ID Numbers: 112025
First Submitted: December 18, 2008
First Posted: December 22, 2008
Results First Submitted: July 10, 2017
Results First Posted: September 19, 2017
Last Update Posted: September 19, 2017