Back to resultsDose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily
Primary Purpose
Asthma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Fluticasone Propionate 100mcg via ACCUHALER/DISKUS
GSK2190915 100mg
GSK2190915 10mg
GSK2190915 300mg
GSK2190915 30mg
Montelukast 10mg
Placebo GSK2190915 one tablet
Placebo montelukast
Placebo fluticasone propionate via ACCUHALER/DISKUS
Placebo GSK2190915 two tablets
Sponsored by
About this trial
This is an interventional treatment trial for Asthma focused on measuring Efficacy, Asthma, Safety, Fluticasone Propionate, FLAP, Beta-agonists, GSK2190915, Montelukast, Placebo, FLAIR
Eligibility Criteria
Inclusion Criteria:
- Type of Subject: Outpatient
- Age: ≥12 years of age
- Gender: Eligible Female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control)
- Asthma Diagnosis: As defined by NIH
- Severity of Disease: FEV1 50-85% predicted AND in current and former smokers a post salbutamol/albuterol ratio >0.70
- Reversibility: ≥12% and ≥200mL in FEV1 within 30 ±15 minutes following salbutamol/albuterol
- Current anti-asthma therapy: Using short-acting beta-agonist (SABA) for ≥3 months
- Tobacco use: Non-smoker /former smoker with ≤10 pack years or current smoker with ≤10 pack years
- QTC: QTc(F)<450msec or QTc(F)<480 for subjects with Bundle Branch Block
- Liver function: Normal liver function
- Informed Consent
Exclusion Criteria:
- History of Life-threatening asthma: Within previous 5 years
- Asthma Exacerbation: Requiring OCS within 3 months or hospitalisation within 6 months
- Respiratory Infection: Not resolved within the 4 weeks before V1 AND led to a change in asthma management OR treatment with antibiotics OR is expected to affect the subject's asthma status or ability to participate
- Corticosteroid Use: ICS used within 6 weeks or OCS/depot corticosteroids within 12 weeks
- OATP1B1 substrates: OATP1B1 substrates (e.g. statins, rifampicin, bromosulphophthalein, benzylpenicillin, methotrexate) within 4 weeks
- Immunosuppressive medications: Either using or required during the study
- Liver disease: Current or chronic history
- Concurrent disease/abnormalities: Clinically significant uncontrolled disease
- Investigational medications: Participation in a study or used investigational drug within 30 days
- Drug allergy: β-agonists, corticosteroids, constituents of inhalers
- Milk Protein Allergy: History of severe milk protein allergy
- Compliance: Factors likely to impair compliance either with regards to study medication, procedures or attendance
- Unable or unwilling to follow instructions: Procedures, dosing directions, e-diaries or pMDIs
- History of alcohol or drug abuse: Likely to interfere with the study
- Affiliation with Investigator's Site: Relative or employee
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm Type
Experimental
Experimental
Experimental
Experimental
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
GSK2190915 10mg and placebo
GSK2190915 30mg and placebo
GSK2190915 100mg QD and placebo
GSK2190915 300mg QD and placebo
Fluticasone propionate 100mcg and placebo
Montelukast 10mg and placebo
Placebo Comparator
Arm Description
GSK2190915 10mg (1 x 10mg, 1 x placebo tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS
GSK2190915 30mg (1 x 30mg, 1 x placebo tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS
GSK2190915 100mg (1 x 100mg, 1 x placebo tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS
GSK2190915 300mg (1 x 100mg, 1 x 200mg tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS
Fluticasone propionate 100mcg twice daily via ACCUHALER/DISKUS and two placebo tablets in the morning and one placebo capsule in the evening
Montelukast 10mg (1 x 10mg capsule) once daily in the evening and two placebo tablets in the morning and inhaled placebo twice daily via ACCUHALER/DISKUS
Two GSK2190915 placebo tablets once daily in the morning, montelukast placebo capsule once daily in the evening and fluticasone propionate placebo twice daily via ACCUHALER/DISKUS
Outcomes
Primary Outcome Measures
Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1)
Pulmonary function was measured by forced expiratory volume in one second, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the morning (AM) pre-dose and pre-rescue bronchodilator FEV1 at the clinic visit. Baseline was the pre-dose value obtained at Visit 3. Change from Baseline was calculated as the end of Week 8 value minus the Baseline value. Analysis of covariance (ANCOVA) model used for statistical analysis. ITT Population was comprised of all participant randomized to treatment who received at least one dose of double-blind study medication.
Secondary Outcome Measures
Mean Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 8-Week Treatment Period
Peak expiratory flow is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Change from Baseline was calculated as the value of the averaged PEF daily (pre-dose and pre-rescue bronchodilator) evening over the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants)
Mean Change From Baseline in Daily Trough AM PEF Averaged Over the 8-Week Treatment Period
The PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough AM PEF is defined as the AM pre-dose and pre-rescue bronchodilator at the clinic visit. Change from Baseline was calculated as the value of the averaged PEF daily (pre-dose and pre-rescue bronchodilator) AM over the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
Mean Change From Baseline in the Percentage of Symptom-free Days Averaged Over the 8-Week Treatment Period
Asthma symptoms were recorded in a daily electronic diary (eDiary) by the participants every day in the evening at bedtime and before taking any rescue or study medication and before the assessment of the PEF measurement. Participant's responses to evening assessments indicated no symptoms were considered to be symptom free. For participants, the symptom free days were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of symptom-free days during the 8-Week treatment period minus the Baseline value. Baseline was defined as the last 7 days prior to randomization of the participants.
Mean Change From Baseline in the Percentage of Symptom-free Nights Averaged Over the 8-Week Treatment Period
Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning upon rising and before taking any rescue or study medication and before the assessment of the PEF measurement. Participant's responses to the morning assessments indicated no symptoms were considered to be symptom free. For participants, the symptom free nights were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of symptom-free nights during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
Mean Change From Baseline in the Percentage of Rescue-free Days Averaged Over the 8-Week Treatment Period
The number of inhalations of rescue salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. For participants, the rescue-free days were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of rescue-free days during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
Mean Change From Baseline in the Percentage of Rescue-free Nights Averaged Over the 8-Week Treatment Period
The number of inhalations of rescue salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. For participants, the rescue-free nights were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of rescue-free nights during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
Mean Change From Baseline in Day-time Asthma Symptom Score Over the 8-Week Treatment Period
Participants recorded their day-time asthma symptom score in an eDiary each PM at bedtime and before taking any rescue or study medication and before assessing the PEF measurement during the 8-Week treatment period. Day-time asthma symptom scores, as: 0=no asthma symptoms, 1=one episode of short-time asthma symptoms, 2=two or more episodes of short-time asthma symptoms, 3=asthma symptoms occurring during most part of daytime without interference with daily life activities, 4=asthma symptoms occurring during most part of daytime with interference with daily life activities, 5=severe asthma symptoms that disable working or perform normal daily activities. Change from Baseline was calculated as the averaged of day-time asthma symptom score during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
Mean Change From Baseline in Night-time Asthma Symptom Score Over the 8-Week Treatment Period
Participants recorded their night-time asthma symptom score in an eDiary each AM upon rising and before taking any rescue or study medication and before assessing the PEF measurement during the 8-Week treatment period. Night-time asthma symptom scores, as: 0=no asthma symptoms, 1= one awakening or waking early due to asthma symptoms, 2= two or more awakenings due to asthma symptoms (including waking early), 3= asthma symptoms almost prevented the participant from sleeping, 4= severe asthma symptoms completely prevented from sleeping. Change from Baseline was calculated as the averaged of night-time asthma symptom score during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
Mean Change From Baseline in Day-time Rescue Short Acting beta2-agonist (SABA) Usage Over the 8-Week Treatment Period
The number of inhalations of rescue SABA, salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. Participants who used salbutamol/albuterol inhalation aerosol at day-time were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged number of day-time salbutamol/albuterol inhalation aerosol used during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
Mean Change From Baseline in Night-time Rescue SABA Usage Over the 8-Week Treatment Period
The numbers of inhalations of rescue SABA, salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. Participants who used salbutamol/albuterol inhalation aerosol at night-time were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged number of night-time salbutamol/albuterol inhalation aerosol used during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period
The participants who met any of the following withdrawal criteria were considered to be withdrawn due to lack of efficacy: 1) Clinic FEV1 below stability limit calculated at Visit 3. 2) More than three days between two consecutive visits, PEF has fallen below stability limit calculated at Visit 3. 3) Use of 12 or more inhalations of SABA per day for more than two days between consecutive visits. 4) Asthma exacerbation defined as worsening requiring any treatment other than study medication or rescue medication. This included requiring the use of systemic or inhaled corticosteroids and /or emergency room visit or hospitalization for the treatment of asthma. The stability limit was calculated as best pre-salbutamol/albuterol FEV1 at Visit 3 x 80 percent (%).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01147744
Brief Title
Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily
Official Title
A Randomised Double-Blind, Double-Dummy, Placebo-Controlled, Stratified, Parallel-Group, Multicentre, Dose Ranging Study to Evaluate the Efficacy and Safety of GSK2190915 Tablets Administered Once Daily, Fluticasone Propionate Inhalation Powder 100mcg Twice Daily and Montelukast 10mg Once Daily Compared With Placebo for 8 Weeks in Adolescent and Adult Subjects With Persistent Asthma While Treated With Short Acting Beta2-agonist.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
June 28, 2010 (Actual)
Primary Completion Date
October 6, 2011 (Actual)
Study Completion Date
October 6, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the efficacy, dose response and safety of four doses of GSK2190915 in tablet form (10mg, 30mg, 100mg and 300mg) administered once daily, over 8 weeks compared with placebo in adolescent and adult subjects (12 years of age and older) with persistent asthma. These data will form the basis for the selection of the optimal daily dose of GSK2190915 to be carried forward in Phase III asthma studies. The study also includes Fluticasone Propionate Inhalation Powder (100 mcg, twice daily) and Montelukast (10mg, once daily) to allow for an exploratory analysis of the efficacy of GSK2190915 versus a low dose inhaled corticosteroid and a leukotriene receptor antagonist.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Efficacy, Asthma, Safety, Fluticasone Propionate, FLAP, Beta-agonists, GSK2190915, Montelukast, Placebo, FLAIR
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
700 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GSK2190915 10mg and placebo
Arm Type
Experimental
Arm Description
GSK2190915 10mg (1 x 10mg, 1 x placebo tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS
Arm Title
GSK2190915 30mg and placebo
Arm Type
Experimental
Arm Description
GSK2190915 30mg (1 x 30mg, 1 x placebo tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS
Arm Title
GSK2190915 100mg QD and placebo
Arm Type
Experimental
Arm Description
GSK2190915 100mg (1 x 100mg, 1 x placebo tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS
Arm Title
GSK2190915 300mg QD and placebo
Arm Type
Experimental
Arm Description
GSK2190915 300mg (1 x 100mg, 1 x 200mg tablets) once daily in the morning and placebo caspule once daily in the evening and inhaled placebo twice daily via ACCUHALER/DISKUS
Arm Title
Fluticasone propionate 100mcg and placebo
Arm Type
Active Comparator
Arm Description
Fluticasone propionate 100mcg twice daily via ACCUHALER/DISKUS and two placebo tablets in the morning and one placebo capsule in the evening
Arm Title
Montelukast 10mg and placebo
Arm Type
Active Comparator
Arm Description
Montelukast 10mg (1 x 10mg capsule) once daily in the evening and two placebo tablets in the morning and inhaled placebo twice daily via ACCUHALER/DISKUS
Arm Title
Placebo Comparator
Arm Type
Placebo Comparator
Arm Description
Two GSK2190915 placebo tablets once daily in the morning, montelukast placebo capsule once daily in the evening and fluticasone propionate placebo twice daily via ACCUHALER/DISKUS
Intervention Type
Drug
Intervention Name(s)
Fluticasone Propionate 100mcg via ACCUHALER/DISKUS
Intervention Description
Fluticasone propionate 100mcg twice daily via ACCUHALER/DISKUS
Intervention Type
Drug
Intervention Name(s)
GSK2190915 100mg
Intervention Description
GSK2190915 100mg (1 x 100mg) once daily in the morning
Intervention Type
Drug
Intervention Name(s)
GSK2190915 10mg
Intervention Description
GSK2190915 10mg (1 x 10mg) once daily in the morning
Intervention Type
Drug
Intervention Name(s)
GSK2190915 300mg
Intervention Description
GSK2190915 300mg (1 x 100mg, 1 x 200mg tablets) once daily in the morning
Intervention Type
Drug
Intervention Name(s)
GSK2190915 30mg
Intervention Description
GSK2190915 30mg (1 x 30mg) once daily in the morning
Intervention Type
Drug
Intervention Name(s)
Montelukast 10mg
Intervention Description
Montelukast 10mg (1 x 10mg capsule) once daily in the evening
Intervention Type
Drug
Intervention Name(s)
Placebo GSK2190915 one tablet
Intervention Description
Placebo tablet, one tablet once daily in the morning
Intervention Type
Drug
Intervention Name(s)
Placebo montelukast
Intervention Description
Placebo capsule once daily in the evening
Intervention Type
Drug
Intervention Name(s)
Placebo fluticasone propionate via ACCUHALER/DISKUS
Intervention Description
Inhaled placebo twice daily via ACCUHALER/DISKUS
Intervention Type
Drug
Intervention Name(s)
Placebo GSK2190915 two tablets
Intervention Description
Placebo tablet, two tablets once daily in the morning
Primary Outcome Measure Information:
Title
Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1)
Description
Pulmonary function was measured by forced expiratory volume in one second, defined as the maximal amount of air that can be forcefully exhaled in one second. Trough FEV1 is defined as the morning (AM) pre-dose and pre-rescue bronchodilator FEV1 at the clinic visit. Baseline was the pre-dose value obtained at Visit 3. Change from Baseline was calculated as the end of Week 8 value minus the Baseline value. Analysis of covariance (ANCOVA) model used for statistical analysis. ITT Population was comprised of all participant randomized to treatment who received at least one dose of double-blind study medication.
Time Frame
Baseline and Week 8
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 8-Week Treatment Period
Description
Peak expiratory flow is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Change from Baseline was calculated as the value of the averaged PEF daily (pre-dose and pre-rescue bronchodilator) evening over the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants)
Time Frame
Baseline up to Week 8
Title
Mean Change From Baseline in Daily Trough AM PEF Averaged Over the 8-Week Treatment Period
Description
The PEF is defined as the maximum airflow during a forced expiration beginning with the lungs fully inflated. Trough AM PEF is defined as the AM pre-dose and pre-rescue bronchodilator at the clinic visit. Change from Baseline was calculated as the value of the averaged PEF daily (pre-dose and pre-rescue bronchodilator) AM over the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
Time Frame
Baseline up to Week 8
Title
Mean Change From Baseline in the Percentage of Symptom-free Days Averaged Over the 8-Week Treatment Period
Description
Asthma symptoms were recorded in a daily electronic diary (eDiary) by the participants every day in the evening at bedtime and before taking any rescue or study medication and before the assessment of the PEF measurement. Participant's responses to evening assessments indicated no symptoms were considered to be symptom free. For participants, the symptom free days were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of symptom-free days during the 8-Week treatment period minus the Baseline value. Baseline was defined as the last 7 days prior to randomization of the participants.
Time Frame
Baseline up to Week 8
Title
Mean Change From Baseline in the Percentage of Symptom-free Nights Averaged Over the 8-Week Treatment Period
Description
Asthma symptoms were recorded in a daily eDairy by the participants every day in the morning upon rising and before taking any rescue or study medication and before the assessment of the PEF measurement. Participant's responses to the morning assessments indicated no symptoms were considered to be symptom free. For participants, the symptom free nights were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of symptom-free nights during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
Time Frame
Baseline up to Week 8
Title
Mean Change From Baseline in the Percentage of Rescue-free Days Averaged Over the 8-Week Treatment Period
Description
The number of inhalations of rescue salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. For participants, the rescue-free days were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of rescue-free days during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
Time Frame
Baseline up to Week 8
Title
Mean Change From Baseline in the Percentage of Rescue-free Nights Averaged Over the 8-Week Treatment Period
Description
The number of inhalations of rescue salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. The time span during which the participants did not have to take any rescue medication (medication intended to relieve symptoms immediately) was considered to be a rescue-free period. For participants, the rescue-free nights were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged of rescue-free nights during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
Time Frame
Baseline up to Week 8
Title
Mean Change From Baseline in Day-time Asthma Symptom Score Over the 8-Week Treatment Period
Description
Participants recorded their day-time asthma symptom score in an eDiary each PM at bedtime and before taking any rescue or study medication and before assessing the PEF measurement during the 8-Week treatment period. Day-time asthma symptom scores, as: 0=no asthma symptoms, 1=one episode of short-time asthma symptoms, 2=two or more episodes of short-time asthma symptoms, 3=asthma symptoms occurring during most part of daytime without interference with daily life activities, 4=asthma symptoms occurring during most part of daytime with interference with daily life activities, 5=severe asthma symptoms that disable working or perform normal daily activities. Change from Baseline was calculated as the averaged of day-time asthma symptom score during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
Time Frame
Baseline up to Week 8
Title
Mean Change From Baseline in Night-time Asthma Symptom Score Over the 8-Week Treatment Period
Description
Participants recorded their night-time asthma symptom score in an eDiary each AM upon rising and before taking any rescue or study medication and before assessing the PEF measurement during the 8-Week treatment period. Night-time asthma symptom scores, as: 0=no asthma symptoms, 1= one awakening or waking early due to asthma symptoms, 2= two or more awakenings due to asthma symptoms (including waking early), 3= asthma symptoms almost prevented the participant from sleeping, 4= severe asthma symptoms completely prevented from sleeping. Change from Baseline was calculated as the averaged of night-time asthma symptom score during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
Time Frame
Baseline up to Week 8
Title
Mean Change From Baseline in Day-time Rescue Short Acting beta2-agonist (SABA) Usage Over the 8-Week Treatment Period
Description
The number of inhalations of rescue SABA, salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. Participants who used salbutamol/albuterol inhalation aerosol at day-time were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged number of day-time salbutamol/albuterol inhalation aerosol used during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
Time Frame
Baseline up to Week
Title
Mean Change From Baseline in Night-time Rescue SABA Usage Over the 8-Week Treatment Period
Description
The numbers of inhalations of rescue SABA, salbutamol/albuterol inhalation aerosol used during the day and night was recorded by the participants in an eDiary. Participants who used salbutamol/albuterol inhalation aerosol at night-time were assessed during the 8-Week treatment period. Change from Baseline was calculated as the averaged number of night-time salbutamol/albuterol inhalation aerosol used during the 8-Week treatment period minus the Baseline value (defined as the last 7 days prior to randomization of the participants).
Time Frame
Baseline up to Week 8
Title
Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period
Description
The participants who met any of the following withdrawal criteria were considered to be withdrawn due to lack of efficacy: 1) Clinic FEV1 below stability limit calculated at Visit 3. 2) More than three days between two consecutive visits, PEF has fallen below stability limit calculated at Visit 3. 3) Use of 12 or more inhalations of SABA per day for more than two days between consecutive visits. 4) Asthma exacerbation defined as worsening requiring any treatment other than study medication or rescue medication. This included requiring the use of systemic or inhaled corticosteroids and /or emergency room visit or hospitalization for the treatment of asthma. The stability limit was calculated as best pre-salbutamol/albuterol FEV1 at Visit 3 x 80 percent (%).
Time Frame
Upto 8 Weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Type of Subject: Outpatient
Age: ≥12 years of age
Gender: Eligible Female (females of childbearing potential must commit to consistent and correct use of an acceptable method of birth control)
Asthma Diagnosis: As defined by NIH
Severity of Disease: FEV1 50-85% predicted AND in current and former smokers a post salbutamol/albuterol ratio >0.70
Reversibility: ≥12% and ≥200mL in FEV1 within 30 ±15 minutes following salbutamol/albuterol
Current anti-asthma therapy: Using short-acting beta-agonist (SABA) for ≥3 months
Tobacco use: Non-smoker /former smoker with ≤10 pack years or current smoker with ≤10 pack years
QTC: QTc(F)<450msec or QTc(F)<480 for subjects with Bundle Branch Block
Liver function: Normal liver function
Informed Consent
Exclusion Criteria:
History of Life-threatening asthma: Within previous 5 years
Asthma Exacerbation: Requiring OCS within 3 months or hospitalisation within 6 months
Respiratory Infection: Not resolved within the 4 weeks before V1 AND led to a change in asthma management OR treatment with antibiotics OR is expected to affect the subject's asthma status or ability to participate
Corticosteroid Use: ICS used within 6 weeks or OCS/depot corticosteroids within 12 weeks
OATP1B1 substrates: OATP1B1 substrates (e.g. statins, rifampicin, bromosulphophthalein, benzylpenicillin, methotrexate) within 4 weeks
Immunosuppressive medications: Either using or required during the study
Liver disease: Current or chronic history
Concurrent disease/abnormalities: Clinically significant uncontrolled disease
Investigational medications: Participation in a study or used investigational drug within 30 days
Drug allergy: β-agonists, corticosteroids, constituents of inhalers
Milk Protein Allergy: History of severe milk protein allergy
Compliance: Factors likely to impair compliance either with regards to study medication, procedures or attendance
Unable or unwilling to follow instructions: Procedures, dosing directions, e-diaries or pMDIs
History of alcohol or drug abuse: Likely to interfere with the study
Affiliation with Investigator's Site: Relative or employee
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
GSK Investigational Site
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
GSK Investigational Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Facility Name
GSK Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
GSK Investigational Site
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
GSK Investigational Site
City
Owensboro
State/Province
Kentucky
ZIP/Postal Code
42301
Country
United States
Facility Name
GSK Investigational Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
GSK Investigational Site
City
Bangor
State/Province
Maine
ZIP/Postal Code
04401
Country
United States
Facility Name
GSK Investigational Site
City
Ypsilanti
State/Province
Michigan
ZIP/Postal Code
48197
Country
United States
Facility Name
GSK Investigational Site
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
GSK Investigational Site
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65203
Country
United States
Facility Name
GSK Investigational Site
City
Rolla
State/Province
Missouri
ZIP/Postal Code
65401
Country
United States
Facility Name
GSK Investigational Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
GSK Investigational Site
City
Ocean City
State/Province
New Jersey
ZIP/Postal Code
07712
Country
United States
Facility Name
GSK Investigational Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
GSK Investigational Site
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
GSK Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
GSK Investigational Site
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
GSK Investigational Site
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
GSK Investigational Site
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
GSK Investigational Site
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
GSK Investigational Site
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Plovdiv
ZIP/Postal Code
4003
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Ruse
ZIP/Postal Code
7000
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Sofia
ZIP/Postal Code
1000
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Sofia
ZIP/Postal Code
1202
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Sofia
ZIP/Postal Code
1407
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Stara Zagora
ZIP/Postal Code
6000
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Varna
ZIP/Postal Code
9010
Country
Bulgaria
Facility Name
GSK Investigational Site
City
Chiba
ZIP/Postal Code
292-0805
Country
Japan
Facility Name
GSK Investigational Site
City
Fukuoka
ZIP/Postal Code
819-0006
Country
Japan
Facility Name
GSK Investigational Site
City
Fukuoka
ZIP/Postal Code
819-1102
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
062-0034
Country
Japan
Facility Name
GSK Investigational Site
City
Hokkaido
ZIP/Postal Code
064-0801
Country
Japan
Facility Name
GSK Investigational Site
City
Ibaraki
ZIP/Postal Code
319-1113
Country
Japan
Facility Name
GSK Investigational Site
City
Kanagawa
ZIP/Postal Code
210-0852
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
530-0001
Country
Japan
Facility Name
GSK Investigational Site
City
Osaka
ZIP/Postal Code
565-0853
Country
Japan
Facility Name
GSK Investigational Site
City
Saitama
ZIP/Postal Code
343-0851
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
102-0083
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
103-0027
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
103-0028
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
130-8587
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
153-0051
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
154-0024
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
158-0097
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
171-0014
Country
Japan
Facility Name
GSK Investigational Site
City
Tokyo
ZIP/Postal Code
190-0013
Country
Japan
Facility Name
GSK Investigational Site
City
Bialystok
ZIP/Postal Code
15-084
Country
Poland
Facility Name
GSK Investigational Site
City
Katowice
ZIP/Postal Code
40-018
Country
Poland
Facility Name
GSK Investigational Site
City
Krakow
ZIP/Postal Code
31-024
Country
Poland
Facility Name
GSK Investigational Site
City
Libiaz
ZIP/Postal Code
32-590
Country
Poland
Facility Name
GSK Investigational Site
City
Lodz
ZIP/Postal Code
93-329
Country
Poland
Facility Name
GSK Investigational Site
City
Poznan
ZIP/Postal Code
60-693
Country
Poland
Facility Name
GSK Investigational Site
City
Tarnow
ZIP/Postal Code
33-100
Country
Poland
Facility Name
GSK Investigational Site
City
Brasov
ZIP/Postal Code
500112
Country
Romania
Facility Name
GSK Investigational Site
City
Bucharest
ZIP/Postal Code
020125
Country
Romania
Facility Name
GSK Investigational Site
City
Bucharest
ZIP/Postal Code
022102
Country
Romania
Facility Name
GSK Investigational Site
City
Bucharest
ZIP/Postal Code
050159
Country
Romania
Facility Name
GSK Investigational Site
City
Cluj-Napoca
ZIP/Postal Code
400217
Country
Romania
Facility Name
GSK Investigational Site
City
Cluj-Napoca
ZIP/Postal Code
400371
Country
Romania
Facility Name
GSK Investigational Site
City
Deva
ZIP/Postal Code
330084
Country
Romania
Facility Name
GSK Investigational Site
City
Timisoara
ZIP/Postal Code
300310
Country
Romania
Facility Name
GSK Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49006
Country
Ukraine
Facility Name
GSK Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
GSK Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49051
Country
Ukraine
Facility Name
GSK Investigational Site
City
Donetsk
ZIP/Postal Code
83099
Country
Ukraine
Facility Name
GSK Investigational Site
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
GSK Investigational Site
City
Kharkiv
ZIP/Postal Code
61002
Country
Ukraine
Facility Name
GSK Investigational Site
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
GSK Investigational Site
City
Kharkiv
ZIP/Postal Code
61124
Country
Ukraine
Facility Name
GSK Investigational Site
City
Kiev
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
GSK Investigational Site
City
Kyiv
ZIP/Postal Code
02232
Country
Ukraine
Facility Name
GSK Investigational Site
City
Kyiv
ZIP/Postal Code
03115
Country
Ukraine
Facility Name
GSK Investigational Site
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
GSK Investigational Site
City
Kyiv
ZIP/Postal Code
04107
Country
Ukraine
Facility Name
GSK Investigational Site
City
Kyiv
ZIP/Postal Code
04201
Country
Ukraine
Facility Name
GSK Investigational Site
City
Kyiv
Country
Ukraine
Facility Name
GSK Investigational Site
City
Odesa
ZIP/Postal Code
65114
Country
Ukraine
Facility Name
GSK Investigational Site
City
Simferopol
ZIP/Postal Code
95043
Country
Ukraine
Facility Name
GSK Investigational Site
City
Yalta
ZIP/Postal Code
98603
Country
Ukraine
Facility Name
GSK Investigational Site
City
Zaporizhia
ZIP/Postal Code
69035
Country
Ukraine
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Citations:
PubMed Identifier
23682661
Citation
Follows RM, Snowise NG, Ho SY, Ambery CL, Smart K, McQuade BA. Efficacy, safety and tolerability of GSK2190915, a 5-lipoxygenase activating protein inhibitor, in adults and adolescents with persistent asthma: a randomised dose-ranging study. Respir Res. 2013 May 17;14(1):54. doi: 10.1186/1465-9921-14-54.
Results Reference
derived
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Annotated Case Report Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112186
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112186
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112186
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112186
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112186
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112186
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
112186
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Learn more about this trial
Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily
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