AsthmaPhase 2NCT01156792
Safety and Efficacy Study of Adding GSK2190915 to Low Dose Inhaled Corticosteroid Treatment for Asthma Subjects > or = 12 Years of Age
A Phase 2 study testing FP 100, GSK2190915 100 and GSK2190915 300 in people with Asthma, run by GlaxoSmithKline at 32 sites in United States.
Trial summary
The primary objective of this study is to evaluate the efficacy and safety of adding GSK2190915 100mg, GSK2190915 300mg or placebo tablets administered once daily to fluticasone propionate 100mcg inhalation administered twice daily in uncontrolled asthmatic subjects > or = 12 years of age over the course of 6 weeks… 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?
- FP 100, GSK2190915 100 and GSK2190915 300
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 162 participants
- Where
- 32 sitesUnited States
- Study dates
- Sep 2010to 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
- Age: 12 years of age or older
- Non-, former or current smokers with a documented smoking history of ≤ 10 pack years
- Asthma diagnosis as defined by the National Institutes of Health
- Best FEV1 of 50% to <80% of the predicted normal value
- Post-albuterol FEV1/FVC ratio of >0.70 at Visit 1/1a (between 5:00AM and 12:00 noon)
- ≥ 12% and ≥200mL reversibility of FEV1
Show all 10Show fewer
- Must have been using FP 100mcg inhalation powder BID for at least 2 weeks just prior to Visit 1.
- Must be able to replace their current short-acting beta2-agonists with albuterol inhalation aerosol
- Must be able and willing to give written informed consent to take part in the study.
- Must be able and willing to comply with all aspects of the study including completion of daily e-Diary.
Who cannot join
- History of life-threatening asthma
- Recent asthma exacerbation
- Concurrent respiratory disease
- Recent respiratory infection
- Liver disease
- Other concurrent diseases/abnormalities
Show all 17Show fewer
- Oral candidiasis
- Drug allergy
- Milk protein allergy
- Immunosuppressive Medications
- Administration of systemic, oral or depot corticosteroids within 12 weeks of Visit 1
- OATP1B1 substrates within 4 weeks of Visit 1
- Cytochrome P450 3A4 (CYP 3A4) Inhibitors
- Cytochrome P450 3A4 (CYP 3A4) Inducers
- Investigational Medications
- Compliance: any infirmity, disability, or geographical location which seems likely (in the opinion of the Investigator) to impair compliance with any aspect of this study protocol
- Affiliation with Investigator's Site
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
GSK Investigational Site
Austin, Texas, 78750
GSK Investigational Site
Bangor, Maine, 04401
GSK Investigational Site
Bellevue, Nebraska, 68123-4303
GSK Investigational Site
Bethlehem, Pennsylvania, 18020
GSK Investigational Site
Birmingham, Alabama, 35209
GSK Investigational Site
Canton, Ohio, 44718
GSK Investigational Site
Cincinnati, Ohio, 45231
GSK Investigational Site
Coral Gables, Florida, 33134
GSK Investigational Site
Dallas, Texas, 75230
GSK Investigational Site
Houston, Texas, 77054
GSK Investigational Site
Huntington Beach, California, 92647
GSK Investigational Site
Indianapolis, Indiana, 46208
GSK Investigational Site
Lenexa, Kansas, 66215
GSK Investigational Site
Little Rock, Arkansas, 72205
GSK Investigational Site
Los Angeles, California, 90048
GSK Investigational Site
Madison, Wisconsin, 53792
GSK Investigational Site
Metairie, Louisiana, 70006
GSK Investigational Site
Miami, Florida, 33173
GSK Investigational Site
Minneapolis, Minnesota, 55402
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
Pittsburgh, Pennsylvania, 15241
GSK Investigational Site
Plano, Texas, 75024
GSK Investigational Site
South Burlington, Vermont, 05403
GSK Investigational Site
St Louis, Missouri, 63110
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Vista, California, 92083
GSK Investigational Site
Waco, Texas, 76712
GSK Investigational Site
Wilmington, North Carolina, 28401
GSK Investigational Site
Ypsilanti, Michigan, 48197
About this study
Official title: A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Five-Treatment, Four 6-Week Period Cross-Over, Multi-Center Study to Evaluate the Effect of Adding GSK2190915 100mg, GSK2190915 300mg, Montelukast 10mg or Placebo Tablets Once Daily or Salmeterol 50mcg Inhalation Powder Twice Daily to Fluticasone Propionate 100mcg Inhalation Powder Twice Daily in Uncontrolled Asthmatic Subjects ≥ 12 Years of Age
The primary objective of this study is to evaluate the efficacy and safety of adding GSK2190915 100mg, GSK2190915 300mg or placebo tablets administered once daily to fluticasone propionate 100mcg inhalation administered twice daily in uncontrolled asthmatic subjects > or = 12 years of age over the course of 6 weeks treatment.
The secondary objectives are to undertake an exploratory analysis of the efficacy and safety of adding montelukast 10mg administered once daily or salmeterol 50mcg administered twice daily to fluticasone propionate 100mcg inhalation administered twice daily and to investigate the pharmacokinetics and pharmacodynamics of GSK2190915 in uncontrolled asthmatic subjects > or = 12 years of age over the course of 6 weeks treatment.
- Conditions
- Asthma
- Being tested
- FP 100, GSK2190915 100, GSK2190915 300, montelukast, placebo
- Keywords
- asthma, GSK2190915
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FP 100Drug
FP 100mcg BID
GSK2190915 100Drug
GSK2190915 100mg QD (AM)
GSK2190915 300Drug
GSK2190915 300mg QD (AM)
montelukastDrug
montelukast 10mg QD (PM)
placeboDrug
placebo BID
FP/SAL 100/50Drug
FP/SAL 100/50mcg BID
| Study group | Role | What they receive |
|---|---|---|
| FP 100mcg BID plus GSK2190915 100mg QD (AM) | Experimental | FP 100mcg BID plus GSK2190915 100mg QD (AM) Receives: Drug: FP 100; Drug: GSK2190915 100 |
| FP 100mcg BID plus GSK2190915 300mg QD (AM) | Experimental | FP 100mcg BID plus GSK2190915 300mg QD (AM) Receives: Drug: FP 100; Drug: GSK2190915 300 |
| FP 100mcg BID plus montelukast 10mg QD (PM) | Active comparator | FP 100mcg BID plus montelukast 10mg QD (PM) Receives: Drug: FP 100; Drug: montelukast |
| FP 100mcg BID plus placebo BID | Active comparator | FP 100mcg BID plus placebo BID Receives: Drug: FP 100; Drug: placebo |
| FP/SAL 100/50mcg BID plus placebo BID | Active comparator | FP/SAL 100/50mcg BID plus placebo BID Receives: Drug: placebo; Drug: FP/SAL 100/50 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough (AM Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in 1 Second (FEV1) at the End of the 6-week Treatment Period
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically using spirometry, prior to study medication and any rescue albuterol (bronchodilator) use. At the end of the 6-week treatment period, FEV1 was measured approximately 24 hours after the participant's last morning dose of study medication and approximately 12 hours after the evening dose of study medication. Trough FEV1 was analyzed using mixed effect analysis of covariance (ANCOVA) model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effect of participant. Intent-to-Treat Population is defined as all participants who were randomized and received at least one dose of study drug.
Measured: End of Week 6
Secondary outcomes (11)
Daily Trough (Morning Pre-dose and Pre-rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Averaged Over the Last 3 Weeks of the 6-week Treatment Period
The PEF is a measure of lung function and measures how fast a person can breathe out. Trough PEF was measured every morning prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily electronic diary (eDiary). Daily trough morning PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
Measured: Week 4 to Week 6
Daily Evening PEF Averaged Over the Last 3 Weeks of the 6-week Treatment Period
The PEF is a measure of lung function and measures how fast a person can breathe out. PEF was measured every evening prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily eDiary. Daily evening PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
Measured: Week 4 to Week 6
Daily (Average of Morning and Evening) PEF Averaged Over the Last 3 Weeks of the 6 -Week Treatment Period Between GSK2190915 and Montelukast Groups
The PEF is a measure of lung function and measures how fast a person can breathe out. PEF was measured every morning and evening prior to study medication dose and any rescue albuterol (bronchodilator) use. Participants recorded PEF in a daily eDiary. Daily average of morning and evening PEF was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant. This outcome measure explored the efficacy between GSK2190915 and montelukast due to the dosing time difference.
Measured: Week 4 to Week 6
Daily Asthma Symptom Score Averaged Over the Last 3 Weeks of the 6-week Treatment Period
Daytime and night time asthma symptoms were recorded every evening at bedtime and every morning upon rising, respectively, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on scales ranging from '0' (implying no symptoms) to either 5 (for daytime symptoms) or 4 (for night time symptoms) (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. 24-hour period asthma symptom scores were averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
Measured: Week 4 to Week 6
Daily Rescue Short-acting beta2-agonist (SABA) Use Averaged Over the Last 3 Weeks of the 6-week Treatment Period
A SABA (albuterol) was provided to participants as a rescue medication, to use as needed for symptomatic relief of asthma symptoms. Participants were required to record their albuterol use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The daily rescue SABA use was averaged over the last 3 weeks of the 6-week treatment period, and analyzed using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
Measured: Week 4 to Week 6
Percentage of Symptom-free Days During the Last 3 Weeks of the 6-week Treatment Period
Daytime asthma symptoms were recorded every evening at bedtime, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 6-point scale ranging from '0' (implying no symptoms) to 5 (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. The number of days when symptoms were not experienced ("symptom-free days") during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
Measured: Week 4 to Week 6
Percentage of Symptom-free Nights During the Last 3 Weeks of the 6 Week Treatment Period
Night time asthma symptoms were recorded every morning upon rising, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 5-point scale ranging from '0' (implying no symptoms) to 4 (implying severe symptoms). Participants recorded the symptoms in a daily eDiary. The number of nights when symptoms were not experienced ("symptom-free nights") during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
Measured: Week 4 to Week 6
Percentage of Rescue-free Days During the Last 3 Weeks of the 6-week Treatment Period
Albuterol was provided as a rescue medication, and participants were required to record rescue medication use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The number of days when rescue medication was not used ("rescue-free days") during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
Measured: Week 4 to Week 6
Percentage of Rescue-free Nights During the Last 3 Weeks of the 6-week Treatment Period
Albuterol was provided as a rescue medication, and participants were required to record rescue medication use in the morning and in the evening. Participants recorded the number of inhalations of rescue medication in a daily eDiary. The number of nights when rescue medication was not used ("rescue-free nights") during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
Measured: Week 4 to Week 6
Percentage of Nights Without Awakenings Due to Asthma During the Last 3 Weeks of the 6-week Treatment Period
Night time asthma symptoms were recorded every morning upon rising, before taking any rescue or study medication and before assessing the PEF. Symptoms were recorded on a 5-point scale: 0 = no symptoms during the night, 1 = symptoms causing to wake once, 2 = symptoms causing to wake twice or more, 3 = symptoms causing to be awake most of the night, 4 = could not sleep due to severe symptoms. Participants recorded the symptoms in a daily eDiary. The number of nights with no awakenings due to asthma during the last 3 weeks of the 6-week treatment period were counted, and percentage calculated by dividing by 21 and multiplying by 100. Analysis was done using mixed effect ANCOVA model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effects of participant.
Measured: Week 4 to Week 6
Number of Participants Withdrawn Due to Lack of Efficacy During the Last 3 Weeks of the 6-week Treatment Period
Participants were withdrawn if they met any of the following three criteria for 'lack of efficacy': 1) Clinic FEV1 below the FEV1 'Stability Limit' value, 2) During any consecutive 7-day period, the participant experienced PEF fallen below the PEF 'Stability Limit' for more than 3 days, or if >= 12 inhalations per day of albuterol were used for more than 2 days, and 3) Ashtma exacerbation. The number of withdrawals due to lack of efficacy were summarized for each treatment and Fisher's Exact test was used for comparison with placebo add-on. Withdrawals occurring during active washout periods are not included.
Measured: Week 4 to Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2010 (estimated)
- Study startSep 2010
- Primary completionOct 2011
- Study completionOct 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 162 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
- NCT01156792
- Sponsor's protocol ID
- 114255
- Status last verified
- Mar 2017
- First submitted
- 1 Jul 2010
- Last updated
- 5 Apr 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
Snowise NG, Clements D, Ho SY, Follows RM. Addition of a 5-lipoxygenase-activating protein inhibitor to an inhaled corticosteroid (ICS) or an ICS/long-acting beta-2-agonist combination in subjects with asthma. Curr Med Res Opin. 2013 Dec;29(12):1663-74. doi: 10.1185/03007995.2013.842163. Epub 2013 Sep 19.
PubMed 24010736
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Double-Dummy, Placebo-Controlled, Five-Treatment, Four 6-Week Period Cross-Over, Multi-Center Study to Evaluate the Effect of Adding GSK2190915 100mg, GSK2190915 300mg, Montelukast 10mg or Placebo Tablets Once Daily or Salmeterol 50mcg Inhalation Powder Twice Daily to Fluticasone Propionate 100mcg Inhalation Powder Twice Daily in Uncontrolled Asthmatic Subjects ≥ 12 Years of Age
- ClinicalTrials.gov ID
- NCT01156792
- Acronym / sponsor ID
- 114255
- Conditions
- Asthma
- Keywords
- asthma, GSK2190915
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 5 Jul 2010 (estimated)
- Results
- Posted 3 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this study is to evaluate the efficacy and safety of adding GSK2190915 100mg, GSK2190915 300mg or placebo tablets administered once daily to fluticasone propionate 100mcg inhalation administered twice daily in uncontrolled asthmatic subjects > or = 12 years of age over the course of 6 weeks treatment.
The secondary objectives are to undertake an exploratory analysis of the efficacy and safety of adding montelukast 10mg administered once daily or salmeterol 50mcg administered twice daily to fluticasone propionate 100mcg inhalation administered twice daily and to investigate the pharmacokinetics and pharmacodynamics of GSK2190915 in uncontrolled asthmatic subjects > or = 12 years of age over the course of 6 weeks treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| FP 100mcg BID plus GSK2190915 100mg QD (AM) | Experimental | Drug: FP 100, Drug: GSK2190915 100FP 100mcg BID plus GSK2190915 100mg QD (AM) |
| FP 100mcg BID plus GSK2190915 300mg QD (AM) | Experimental | Drug: FP 100, Drug: GSK2190915 300FP 100mcg BID plus GSK2190915 300mg QD (AM) |
| FP 100mcg BID plus montelukast 10mg QD (PM) | Active comparator | Drug: FP 100, Drug: montelukastFP 100mcg BID plus montelukast 10mg QD (PM) |
| FP 100mcg BID plus placebo BID | Active comparator | Drug: FP 100, Drug: placeboFP 100mcg BID plus placebo BID |
| FP/SAL 100/50mcg BID plus placebo BID | Active comparator | Drug: placebo, Drug: FP/SAL 100/50FP/SAL 100/50mcg BID plus placebo BID |
Who may qualify
- Ages
- 12 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Age: 12 years of age or older
- Non-, former or current smokers with a documented smoking history of ≤ 10 pack years
- Asthma diagnosis as defined by the National Institutes of Health
- Best FEV1 of 50% to <80% of the predicted normal value
- Post-albuterol FEV1/FVC ratio of >0.70 at Visit 1/1a (between 5:00AM and 12:00 noon)
Key exclusion criteria (17 listed)
- History of life-threatening asthma
- Recent asthma exacerbation
- Concurrent respiratory disease
- Recent respiratory infection
- Liver disease
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 |
|---|---|---|
| FP 100FP 100mcg BID | Drug | FP 100mcg BID plus GSK2190915 100mg QD (AM), FP 100mcg BID plus GSK2190915 300mg QD (AM), FP 100mcg BID plus montelukast 10mg QD (PM), FP 100mcg BID plus placebo BID |
| GSK2190915 100GSK2190915 100mg QD (AM) | Drug | FP 100mcg BID plus GSK2190915 100mg QD (AM) |
| GSK2190915 300GSK2190915 300mg QD (AM) | Drug | FP 100mcg BID plus GSK2190915 300mg QD (AM) |
| montelukastmontelukast 10mg QD (PM) | Drug | FP 100mcg BID plus montelukast 10mg QD (PM) |
| placeboplacebo BID | Drug | FP 100mcg BID plus placebo BID, FP/SAL 100/50mcg BID plus placebo BID |
| FP/SAL 100/50FP/SAL 100/50mcg BID | Drug | FP/SAL 100/50mcg BID plus placebo BID |
Primary outcome
Trough (AM Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in 1 Second (FEV1) at the End of the 6-week Treatment Period
Time frame: End of Week 6
FEV1 is a measure of lung function and is defined as the maximal amount of air that can be forcefully exhaled in one second. FEV1 was measured electronically using spirometry, prior to study medication and any rescue albuterol (bronchodilator) use. At the end of the 6-week treatment period, FEV1 was measured approximately 24 hours after the participant's last morning dose of study medication and approximately 12 hours after the evening dose of study medication. Trough FEV1 was analyzed using mixed effect analysis of covariance (ANCOVA) model for treatment effects, incorporating fixed effects of baseline, period, age, center, smoking status, and random effect of participant. Intent-to-Treat Population is defined as all participants who were randomized and received at least one dose of study drug.
11 secondary outcomes
Daily Trough (Morning Pre-dose and Pre-rescue Bronchodilator) Morning Peak Expiratory Flow (PEF) Averaged Over the Last 3 Weeks of the 6-week Treatment Period
Time frame: Week 4 to Week 6
Daily Evening PEF Averaged Over the Last 3 Weeks of the 6-week Treatment Period
Time frame: Week 4 to Week 6
Daily (Average of Morning and Evening) PEF Averaged Over the Last 3 Weeks of the 6 -Week Treatment Period Between GSK2190915 and Montelukast Groups
Time frame: Week 4 to Week 6
Daily Asthma Symptom Score Averaged Over the Last 3 Weeks of the 6-week Treatment Period
Time frame: Week 4 to Week 6
Daily Rescue Short-acting beta2-agonist (SABA) Use Averaged Over the Last 3 Weeks of the 6-week Treatment Period
Time frame: Week 4 to Week 6
Percentage of Symptom-free Days During the Last 3 Weeks of the 6-week Treatment Period
Time frame: Week 4 to Week 6
Percentage of Symptom-free Nights During the Last 3 Weeks of the 6 Week Treatment Period
Time frame: Week 4 to Week 6
Percentage of Rescue-free Days During the Last 3 Weeks of the 6-week Treatment Period
Time frame: Week 4 to Week 6
Percentage of Rescue-free Nights During the Last 3 Weeks of the 6-week Treatment Period
Time frame: Week 4 to Week 6
Percentage of Nights Without Awakenings Due to Asthma During the Last 3 Weeks of the 6-week Treatment Period
Time frame: Week 4 to Week 6
Number of Participants Withdrawn Due to Lack of Efficacy During the Last 3 Weeks of the 6-week Treatment Period
Time frame: Week 4 to Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24010736Snowise NG, Clements D, Ho SY, Follows RM. Addition of a 5-lipoxygenase-activating protein inhibitor to an inhaled corticosteroid (ICS) or an ICS/long-acting beta-2-agonist combination in subjects with asthma. Curr Med Res Opin. 2013 Dec;29(12):1663-74. doi: 10.1185/03007995.2013.842163. Epub 2013 Sep 19.
- 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
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing FP 100, GSK2190915 100 and GSK2190915 300 in people with Asthma, run by GlaxoSmithKline at 32 sites in United States.
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 10 inclusion and 17 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 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 sites in United States. 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. 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 3 Feb 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?
Trough (AM Pre-dose and Pre-rescue Bronchodilator) Forced Expiratory Volume in 1 Second (FEV1) at the End of the 6-week Treatment Period (time frame: End of Week 6). 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 NCT01156792, 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 5 Apr 2017.