AsthmaPhase 2NCT01147744
Dose Ranging Study Evaluating the Efficacy and Safety of GSK2190915 Administered Once Daily
A Phase 2 study testing Fluticasone Propionate 100mcg via ACCUHALER/DISKUS, GSK2190915 100mg and GSK2190915 10mg in people with Asthma, run by GlaxoSmithKline at 84 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 years and older, women only
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone Propionate 100mcg via ACCUHALER/DISKUS, GSK2190915 100mg and GSK2190915 10mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 700 participants
- Where
- 84 sitesin 6 countries
- Study dates
- 28 Jun 2010to 6 Oct 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
84 sites in 6 countries.
84 sites in 6 countries
United States22 sites
GSK Investigational Site
Bangor, Maine, 04401
GSK Investigational Site
Bellingham, Washington, 98225
GSK Investigational Site
Birmingham, Alabama, 35209
GSK Investigational Site
Canton, Ohio, 44718
GSK Investigational Site
Columbia, Missouri, 65203
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Medford, Oregon, 97504
GSK Investigational Site
Metairie, Louisiana, 70006
GSK Investigational Site
Minneapolis, Minnesota, 55402
GSK Investigational Site
Newport Beach, California, 92663
GSK Investigational Site
Ocean City, New Jersey, 07712
GSK Investigational Site
Oklahoma City, Oklahoma, 73103
GSK Investigational Site
Orangeburg, South Carolina, 29118
GSK Investigational Site
Owensboro, Kentucky, 42301
GSK Investigational Site
Raleigh, North Carolina, 27607
GSK Investigational Site
Rolla, Missouri, 65401
GSK Investigational Site
San Antonio, Texas, 78229
GSK Investigational Site
San Diego, California, 92123
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Tallahassee, Florida, 32308
GSK Investigational Site
Waco, Texas, 76712
GSK Investigational Site
Ypsilanti, Michigan, 48197
Japan19 sites
GSK Investigational Site
Chiba, 292-0805
GSK Investigational Site
Fukuoka, 819-0006
GSK Investigational Site
Fukuoka, 819-1102
GSK Investigational Site
Hokkaido, 062-0034
GSK Investigational Site
Hokkaido, 064-0801
GSK Investigational Site
Ibaraki, 319-1113
GSK Investigational Site
Kanagawa, 210-0852
GSK Investigational Site
Osaka, 530-0001
GSK Investigational Site
Osaka, 565-0853
GSK Investigational Site
Saitama, 343-0851
GSK Investigational Site
Tokyo, 102-0083
GSK Investigational Site
Tokyo, 103-0027
GSK Investigational Site
Tokyo, 103-0028
GSK Investigational Site
Tokyo, 130-8587
GSK Investigational Site
Tokyo, 153-0051
GSK Investigational Site
Tokyo, 154-0024
GSK Investigational Site
Tokyo, 158-0097
GSK Investigational Site
Tokyo, 171-0014
GSK Investigational Site
Tokyo, 190-0013
Ukraine19 sites
GSK Investigational Site
Dnipropetrovsk, 49006
GSK Investigational Site
Dnipropetrovsk, 49027
GSK Investigational Site
Dnipropetrovsk, 49051
GSK Investigational Site
Donetsk, 83099
GSK Investigational Site
Ivano-Frankivsk, 76018
GSK Investigational Site
Kharkiv, 61002
GSK Investigational Site
Kharkiv, 61037
GSK Investigational Site
Kharkiv, 61124
GSK Investigational Site
Kiev, 03680
GSK Investigational Site
Kyiv, 02232
GSK Investigational Site
Kyiv, 03115
GSK Investigational Site
Kyiv, 03680
GSK Investigational Site
Kyiv, 04107
GSK Investigational Site
Kyiv, 04201
GSK Investigational Site
Kyiv
GSK Investigational Site
Odesa, 65114
GSK Investigational Site
Simferopol, 95043
GSK Investigational Site
Yalta, 98603
GSK Investigational Site
Zaporizhia, 69035
Bulgaria9 sites
GSK Investigational Site
Pleven, 5800
GSK Investigational Site
Plovdiv, 4003
GSK Investigational Site
Rousse, 7000
GSK Investigational Site
Sofia, 1000
GSK Investigational Site
Sofia, 1202
GSK Investigational Site
Sofia, 1407
GSK Investigational Site
Sofia, 1431
GSK Investigational Site
Stara Zagora, 6000
GSK Investigational Site
Varna, 9010
Romania8 sites
GSK Investigational Site
Brasov, 500112
GSK Investigational Site
Bucharest, 020125
GSK Investigational Site
Bucharest, 022102
GSK Investigational Site
Bucharest, 050159
GSK Investigational Site
Cluj-Napoca, 400217
GSK Investigational Site
Cluj-Napoca, 400371
GSK Investigational Site
Deva, 330084
GSK Investigational Site
Timișoara, 300310
Poland7 sites
GSK Investigational Site
Bialystok, 15-084
GSK Investigational Site
Katowice, 40-018
GSK Investigational Site
Krakow, 31-024
GSK Investigational Site
Libiąż, 32-590
GSK Investigational Site
Lodz, 93-329
GSK Investigational Site
Poznan, 60-693
GSK Investigational Site
Tarnów, 33-100
About this study
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.
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.
- Conditions
- Asthma
- Being tested
- Fluticasone Propionate 100mcg via ACCUHALER/DISKUS, GSK2190915 100mg, GSK2190915 10mg, GSK2190915 300mg, GSK2190915 30mg
- Keywords
- Efficacy, Asthma, Safety, Fluticasone Propionate, FLAP, Beta-agonists, GSK2190915, Montelukast, Placebo, FLAIR
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone Propionate 100mcg via ACCUHALER/DISKUSDrug
Fluticasone propionate 100mcg twice daily via ACCUHALER/DISKUS
GSK2190915 100mgDrug
GSK2190915 100mg (1 x 100mg) once daily in the morning
GSK2190915 10mgDrug
GSK2190915 10mg (1 x 10mg) once daily in the morning
GSK2190915 300mgDrug
GSK2190915 300mg (1 x 100mg, 1 x 200mg tablets) once daily in the morning
GSK2190915 30mgDrug
GSK2190915 30mg (1 x 30mg) once daily in the morning
Montelukast 10mgDrug
Montelukast 10mg (1 x 10mg capsule) once daily in the evening
Placebo GSK2190915 one tabletDrug
Placebo tablet, one tablet once daily in the morning
Placebo montelukastDrug
Placebo capsule once daily in the evening
Placebo fluticasone propionate via ACCUHALER/DISKUSDrug
Inhaled placebo twice daily via ACCUHALER/DISKUS
Placebo GSK2190915 two tabletsDrug
Placebo tablet, two tablets once daily in the morning
| Study group | Role | What they receive |
|---|---|---|
| GSK2190915 10mg and placebo | Experimental | 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 Receives: Drug: GSK2190915 10mg; Drug: Placebo GSK2190915 one tablet; Drug: Placebo montelukast; Drug: Placebo fluticasone propionate via ACCUHALER/DISKUS |
| GSK2190915 30mg and placebo | Experimental | 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 Receives: Drug: GSK2190915 30mg; Drug: Placebo GSK2190915 one tablet; Drug: Placebo montelukast; Drug: Placebo fluticasone propionate via ACCUHALER/DISKUS |
| GSK2190915 100mg QD and placebo | Experimental | 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 Receives: Drug: GSK2190915 100mg; Drug: Placebo GSK2190915 one tablet; Drug: Placebo montelukast; Drug: Placebo fluticasone propionate via ACCUHALER/DISKUS |
| GSK2190915 300mg QD and placebo | Experimental | 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 Receives: Drug: GSK2190915 300mg; Drug: Placebo montelukast; Drug: Placebo fluticasone propionate via ACCUHALER/DISKUS |
| Fluticasone propionate 100mcg and placebo | Active comparator | Fluticasone propionate 100mcg twice daily via ACCUHALER/DISKUS and two placebo tablets in the morning and one placebo capsule in the evening Receives: Drug: Fluticasone Propionate 100mcg via ACCUHALER/DISKUS; Drug: Placebo montelukast; Drug: Placebo GSK2190915 two tablets |
| Montelukast 10mg and placebo | Active comparator | 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 Receives: Drug: Montelukast 10mg; Drug: Placebo fluticasone propionate via ACCUHALER/DISKUS; Drug: Placebo GSK2190915 two tablets |
| Placebo Comparator | Placebo comparator | 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 Receives: Drug: Placebo montelukast; Drug: Placebo fluticasone propionate via ACCUHALER/DISKUS; Drug: Placebo GSK2190915 two tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and Week 8
Secondary outcomes (11)
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)
Measured: Baseline up to Week 8
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).
Measured: Baseline up to Week 8
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.
Measured: Baseline up to Week 8
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).
Measured: Baseline up to Week 8
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).
Measured: Baseline up to Week 8
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).
Measured: Baseline up to Week 8
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).
Measured: Baseline up to Week 8
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).
Measured: Baseline up to Week 8
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).
Measured: Baseline up to Week
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).
Measured: Baseline up to Week 8
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 (%).
Measured: Upto 8 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study start28 Jun 2010
- Primary completion6 Oct 2011
- Study completion6 Oct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 700 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01147744
- Sponsor's protocol ID
- 112186
- Status last verified
- Sep 2017
- First submitted
- 17 Jun 2010
- Last updated
- 2 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
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.
PubMed 23682661
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT01147744
- Acronym / sponsor ID
- 112186
- Conditions
- Asthma
- Keywords
- Efficacy, Asthma, Safety, Fluticasone Propionate, FLAP, Beta-agonists, GSK2190915, Montelukast
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 28 Jun 2010 (actual)
- Primary completion
- 6 Oct 2011 (actual)
- Study completion
- 6 Oct 2011 (actual)
- First posted
- 22 Jun 2010 (estimated)
- Results
- Posted 6 Sep 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| GSK2190915 10mg and placebo | Experimental | Drug: GSK2190915 10mg, Drug: Placebo GSK2190915 one tablet, Drug: Placebo montelukast, Drug: Placebo fluticasone propionate via ACCUHALER/DISKUSGSK2190915 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 and placebo | Experimental | Drug: GSK2190915 30mg, Drug: Placebo GSK2190915 one tablet, Drug: Placebo montelukast, Drug: Placebo fluticasone propionate via ACCUHALER/DISKUSGSK2190915 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 QD and placebo | Experimental | Drug: GSK2190915 100mg, Drug: Placebo GSK2190915 one tablet, Drug: Placebo montelukast, Drug: Placebo fluticasone propionate via ACCUHALER/DISKUSGSK2190915 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 QD and placebo | Experimental | Drug: GSK2190915 300mg, Drug: Placebo montelukast, Drug: Placebo fluticasone propionate via ACCUHALER/DISKUSGSK2190915 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 and placebo | Active comparator | Drug: Fluticasone Propionate 100mcg via ACCUHALER/DISKUS, Drug: Placebo montelukast, Drug: Placebo GSK2190915 two tabletsFluticasone propionate 100mcg twice daily via ACCUHALER/DISKUS and two placebo tablets in the morning and one placebo capsule in the evening |
| Montelukast 10mg and placebo | Active comparator | Drug: Montelukast 10mg, Drug: Placebo fluticasone propionate via ACCUHALER/DISKUS, Drug: Placebo GSK2190915 two tabletsMontelukast 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 |
| Placebo Comparator | Placebo comparator | Drug: Placebo montelukast, Drug: Placebo fluticasone propionate via ACCUHALER/DISKUS, Drug: Placebo GSK2190915 two tabletsTwo 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 |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone Propionate 100mcg via ACCUHALER/DISKUSFluticasone propionate 100mcg twice daily via ACCUHALER/DISKUS | Drug | Fluticasone propionate 100mcg and placebo |
| GSK2190915 100mgGSK2190915 100mg (1 x 100mg) once daily in the morning | Drug | GSK2190915 100mg QD and placebo |
| GSK2190915 10mgGSK2190915 10mg (1 x 10mg) once daily in the morning | Drug | GSK2190915 10mg and placebo |
| GSK2190915 300mgGSK2190915 300mg (1 x 100mg, 1 x 200mg tablets) once daily in the morning | Drug | GSK2190915 300mg QD and placebo |
| GSK2190915 30mgGSK2190915 30mg (1 x 30mg) once daily in the morning | Drug | GSK2190915 30mg and placebo |
| Montelukast 10mgMontelukast 10mg (1 x 10mg capsule) once daily in the evening | Drug | Montelukast 10mg and placebo |
| Placebo GSK2190915 one tabletPlacebo tablet, one tablet once daily in the morning | Drug | GSK2190915 100mg QD and placebo, GSK2190915 10mg and placebo, GSK2190915 30mg and placebo |
| Placebo montelukastPlacebo capsule once daily in the evening | Drug | Fluticasone propionate 100mcg and placebo, GSK2190915 100mg QD and placebo, GSK2190915 10mg and placebo, GSK2190915 300mg QD and placebo, GSK2190915 30mg and placebo, Placebo Comparator |
| Placebo fluticasone propionate via ACCUHALER/DISKUSInhaled placebo twice daily via ACCUHALER/DISKUS | Drug | GSK2190915 100mg QD and placebo, GSK2190915 10mg and placebo, GSK2190915 300mg QD and placebo, GSK2190915 30mg and placebo, Montelukast 10mg and placebo, Placebo Comparator |
| Placebo GSK2190915 two tabletsPlacebo tablet, two tablets once daily in the morning | Drug | Fluticasone propionate 100mcg and placebo, Montelukast 10mg and placebo, Placebo Comparator |
Primary outcome
Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1)
Time frame: Baseline and Week 8
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.
11 secondary outcomes
Mean Change From Baseline in Daily Evening (PM) Peak Expiratory Flow (PEF) Averaged Over the 8-Week Treatment Period
Time frame: Baseline up to Week 8
Mean Change From Baseline in Daily Trough AM PEF Averaged Over the 8-Week Treatment Period
Time frame: Baseline up to Week 8
Mean Change From Baseline in the Percentage of Symptom-free Days Averaged Over the 8-Week Treatment Period
Time frame: Baseline up to Week 8
Mean Change From Baseline in the Percentage of Symptom-free Nights Averaged Over the 8-Week Treatment Period
Time frame: Baseline up to Week 8
Mean Change From Baseline in the Percentage of Rescue-free Days Averaged Over the 8-Week Treatment Period
Time frame: Baseline up to Week 8
Mean Change From Baseline in the Percentage of Rescue-free Nights Averaged Over the 8-Week Treatment Period
Time frame: Baseline up to Week 8
Mean Change From Baseline in Day-time Asthma Symptom Score Over the 8-Week Treatment Period
Time frame: Baseline up to Week 8
Mean Change From Baseline in Night-time Asthma Symptom Score Over the 8-Week Treatment Period
Time frame: Baseline up to Week 8
Mean Change From Baseline in Day-time Rescue Short Acting beta2-agonist (SABA) Usage Over the 8-Week Treatment Period
Time frame: Baseline up to Week
Mean Change From Baseline in Night-time Rescue SABA Usage Over the 8-Week Treatment Period
Time frame: Baseline up to Week 8
Number of Participants Who Withdrew Due to Lack of Efficacy During the 8-Week Treatment Period
Time frame: Upto 8 Weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 23682661Follows 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.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
84 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluticasone Propionate 100mcg via ACCUHALER/DISKUS, GSK2190915 100mg and GSK2190915 10mg in people with Asthma, run by GlaxoSmithKline at 84 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 84 sites in United States, Japan, Ukraine, Bulgaria, Romania and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Sep 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change From Baseline to the End of the 8-Week Treatment Period in Trough Forced Expiratory Volume in One Second (FEV1) (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01147744, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2017.