AsthmaPhase 2NCT00850642
GSK2190915 Moderate to Severe Asthma Study
A Phase 2 study testing GSK2190195 100mg in people with Asthma, run by GlaxoSmithKline at 8 sites in 2 countries.
Trial summary
A randomised, double-blind, placebo-controlled, parallel group study to evaluate the effect of treatment with GSK2190915, a FLAP inhibitor, as add-on to current inhaled corticosteroid therapy in patients with moderate to severe asthma with elevated sputum neutrophils. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- GSK2190195 100mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 7 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 26 Jun 2009to 2 Jun 2010
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Males and females aged 18 to 65 years inclusive.
- Body mass index within the range 18.5-37.0 kilograms/metre2 (kg/m2).
- An established clinical history of Asthma in accordance with the definition by the GINA Guidelines [GINA, 2006]. Subjects should have at screening or within the last year documented reversibility (>12 %) to short acting bronchodilator, or positive methacholine challenge, or positive histamine challenge (PC20 <8mg/ml).
- A female subject is eligible to participate if she is of: non-childbearing potential defined as pre-menopausal females with documented (medical report verification) hysterectomy or double oophrectomy or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL and estradiol < 40 pg/ml (<140 pmol/L) or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy; childbearing potential and agrees to use one of the contracception methods listed in Section 8.1 for an appropriate period of time prior to the start of dosing and until 3 months after last dose.
- Male subjects must agree to use one of the contraception methods listed in Section 8.1. This criterion must be followed from the time of the first dose of study medication until 3 months after the last dose.
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- Subject with moderate to severe asthma with forced expiratory volume in one second (FEV1) ≥ 50% of predicted.
- Subject who are on regular inhaled corticosteroids without or in combination with a regular long acting Beta 2 Agonist. The dose should be stable for at least 4 weeks before screening.
- Subjects who are taking a minimum of FP 250mg BID or equivalent.
- Persistent sputum neutrophilia defined by sputum neutrophils ≥ 65% with TTC < 15 million cells/g with no evidence of eosinophilia (sputum eosinophils < 2%). Persistent is defined as the criteria being met at screening (or within the 6 months preceding screening) and on visit 1.
- Signed and dated written informed consent is obtained from the subject
- The subject is able to understand and comply with the protocol requirements, instructions and protocol-stated restrictions.
Who cannot join
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Past or present disease, which as judged by the investigator or medical monitor, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, gastrointestinal disease, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease (excluding asthma but including but not confined to chronic bronchitis, emphysema, bronchiectasis, eosinophilic bronchitis or pulmonary fibrosis).
- Clinically significant abnormalities in safety laboratory analysis at screening.
- Subject has uncontrolled hypertension or is hypertensive at screening. Hypertension at screening is defined as persistent systolic BP >150 mmHg or diastolic BP > 90mmHg.
- History of asthma exacerbations or acute intercurrent respiratory illness (viral respiratory syndrome, bronchitis, pneumonia) for a four week period before the screening visit
- History of life-threatening asthma, defined as an asthma episode that required intubations and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures.
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- Subject is unable to abstain from taking prescription or non-prescription drugs (including vitamins and dietary or herbal supplements) including non-steroidal anti-inflammatory drugs (NSAIDs), anti-depressant drugs, anti-histamines and anti-asthma, anti-rhinitis or hay fever medication, with the exception of ICS, LABA and short action beta agonists, from 14 days before screening until the follow-up visit unless in the opinion of the Investigator and sponsor the medication will not interfere with the study
- Administration of oral or injectable steroids within 6 weeks of screening.
- The subject has participated in a study with a new molecular entity during the previous 3 months or has participated in 4 or more clinical studies in the previous 12 months prior to the first dosing day.
- Administration of anti -leukotrienne therapies for 14 days before screening and during the study.
- Administration of any vaccinations within 1 month of screening or during the study.
- Administration of biological therapies within 3 months of the screening visit or during the study
- Subject is undergoing allergen desensitisation therapy.
- Administration of OATP1B1 substrates from 2 weeks before dosing, and until all follow-up assessments are completed.
- There is a risk of non-compliance with study procedures.
- History of blood donation (500 mL) within 3 months of starting the clinical study.
- The subject regularly drinks more than 28 units of alcohol in a week if male, or 21 units per week if female. One unit of alcohol is defined as a medium (125 ml) glass of wine, half a pint (250 ml) of beer or one measure (25 ml) of spirits.
- The subject has a screening QTc value of >450msec, PR interval outside the range 120 to 220msec or an ECG that is not suitable for QT measurements (e.g. poorly defined termination of the T-wave).
- The subject has tested positive for hepatitis C antibody or hepatitis B surface antigen.
- The subject has tested positive for HIV antibodies.
- The subject has a positive pre-study urine drug or urine or breath alcohol screen. A minimum list of drugs that will be screened for include Amphetamines, Barbituates, Cocaine, Opiates, Cannabinoids and Benzodiazepines.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Canada4 sites
GSK Investigational Site
Hamilton, Ontario, L8N 4A6
GSK Investigational Site
Kingston, Ontario, K7L 2V6
GSK Investigational Site
Montreal, Quebec, H4J 1C5
GSK Investigational Site
Sainte-Foy, Quebec, G1V 4G5
United Kingdom4 sites
GSK Investigational Site
Glasgow, Lanarkshire, G12 0YN
GSK Investigational Site
Leicester, Leicestershire, LE3 9QP
GSK Investigational Site
London, NW10 7EW
GSK Investigational Site
Manchester, M23 9QZ
About this study
Official title: The Efficacy of Orally Administered GSK2190915 as an add-on to Current Therapy in Subjects With Moderate to Severe Asthma Who Have Elevated Sputum Neutrophils
A randomised, double-blind, placebo-controlled, parallel group study to evaluate the effect of treatment with GSK2190915, a FLAP inhibitor, as add-on to current inhaled corticosteroid therapy in patients with moderate to severe asthma with elevated sputum neutrophils.
- Conditions
- Asthma
- Being tested
- GSK2190195 100mg, Placebo
- Keywords
- Sputum cell counts, Neutrophils, Severe Asthma, ICS, Inhaled corticosteroids
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK2190195 100mgDrug
GSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor.
PlaceboDrug
Placebo :
2% (w/w) Ethanol, sucralose (5 mg/100 mL of oral solution) to 100 % (w/w) aqueous sodium carbonate buffer (0.010 M, pH 9-10)
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | 12 day repeat dosing with placebo Receives: Drug: Placebo |
| GSK2190915 100mg | Experimental | 12 day repeat dosing treatment phase with 100mg GSK2190915. Receives: Drug: GSK2190195 100mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Numbers of Neutrophils in Induced Sputum-Absolute Neutrophil Count
The neutrophils play an important role in participants with more severe asthma. The reduction in number of neutrophils in induced sputum was evaluated to study the effect of treatment with repeat oral doses of GSK2190915, in asthma participants. Sputum samples were evaluated at central laboratory. The samples were rejected, if the weight was less than 100 grams (g), or if excessive cell degeneration or due to excessive squamous cells and insufficient inflammatory cells. The total cell count of neutrophil was reported as total cell count × 10^6 /g.
Measured: Day -9 to -7, Day 1, Day 12 and follow-up (Day 24-28)
Percentage of Neutrophils in Induced Sputum
The neutrophils play an important role in participants with more severe asthma. The reduction in number of neutrophils in induced sputum was evaluated to study the effect of treatment with repeat oral doses of GSK2190915, in asthma participants. Sputum samples were evaluated at central laboratory. The samples were rejected, if the weight was less than 100 g, or if excessive cell degeneration or due to excessive squamous cells and insufficient inflammatory cells. The total cell count of neutrophil was reported as percentage of cells.
Measured: Day -9 to -7, Day 1, Day 12 and follow-up (Day 24-28)
Secondary outcomes (13)
Assessment of FEV1 on Visit 2, 3 and Visit 4
FEV1 is the amount of air which can be forcefully exhaled in 1 second. It was assessed using a spirometry. Due to early termination of the study, the data of individual participants is reported.
Measured: Visit 2 (Day 1), visit 3 (Day 5 to 7) and visit 4 (Day 12)
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, or is an important medical events that jeopardize the participants or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or a drug-induced liver injury.
Measured: From visit 1 (Day -7 to Day -9) to upto follow-up (upto Day 28)
Number of Participants With Vital Sign of Potential Clinical Concern (PCC)
The vital sign measurement included measurement of systolic and diastolic blood pressure alongwith pulse rate. The PCC values reported for systolic blood pressure were < 85 millimeter of mercury (mmHg) and >160 mmHg; that for diastolic was <45 mmHg and >100 mmHg. The PCC values for pulse rate were <40 and > 110 beats per minute. The number of participants with values outside the PCC for systolic, diastolic blood pressure and vitals during the treatment duration were reported.
Measured: Visit 2 (Day 1) to Upto follow-up (Day 28)
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
The number of participants with abnormal ECG values were reported. The data was reported as Abnormal clinically significant (CS), abnormal not clinically significant (NCS), and No result.
Measured: Visit 2 (Day 1) to Upto follow-up (Day 28)
Number of Participants With Clinical Chemistry Values of PCC
The clinical chemistry parameters evaluated were albumin, calcium, creatinine, glucose, magnesium, phosphorus, potassium, sodium, urea, gamma glutamyl transferase, and bicarbonate. The number of participants with values outside the PCC values were reported. The PCC value observed for bicarbonate was reported.
Measured: Visit 2 (Day 1) to Upto follow-up (Day 28)
Number of Participants With Hematology Values of PCC
The hematology parameters evaluated were white blood cells, neutrophils, hemoglobin, hematocrit, platelets and lymphocytes. The number of participants with values outside the PCC values were reported. The PCC value observed for lymphocyte was reported.
Measured: Visit 2 (Day 1) to Upto follow-up (Day 28)
Plasma Concentration of GSK2190915
The blood samples for analysis of pharmacokinetic parameters were collected at pre-dose and 2 hours post dose on Day 1 and pre-dose trough and 2 hour post dose on Day 12, to evaluate the concentration of the drug GSK2190915 in plasma.
Measured: At Day 1, pre-dose; Day 1, 2 hour; Day 12, pre-dose; and Day 12, 2 hour
Percentage Change From Baseline Urine LTE4 Biomarker
The urine spot samples were collected from the participants at pre-dose on day 1 and trough day 12 for evaluation of LTE4 biomarker. This evaluated the level of inflammation in the airways of the asthma participants. The percentage change from baseline was calculated by dividing the post randomization change by the baseline value from the individual and multiplying by a 100. If either the baseline or post-randomization value is missing, the change from baseline is set to missing. Baseline was defined as Day 1(pre-dose).
Measured: Day 1 and Day 12
Percentage Change From Baseline of LTB4 Biomarker in Plasma
The plasma samples were evaluated for presence of LTB4 biomarkers. The percentage change from baseline was calculated by dividing the post-randomization change by the baseline value from the individual and multiplying by a 100. If either the baseline or post-randomization value is missing, the change from baseline is set to missing. Baseline was defined as Day 1(pre-dose).
Measured: Day 1 and Day 12
Concentration of LTB4 in Sputum
The concentration of LTB4 levels in sputum were evaluated. However due to early termination of the study, the data was not collected.
Measured: Day 1 and Day 12
Concentration of Interleukin (IL)-17 and High-sensitivity C-reactive Protein (hsCRP) in Blood
The blood samples were collected to evaluate the concentration of IL-17 and hsCRP in blood. However due to early termination of the study, the data was not collected.
Measured: Day 1 and Day 12
Assessment of Established Markers of Anti-inflammatory Activity in Sputum: the Measurements Will Include IL-17, Neutrophil Elastase, Myeloperoxidase and IL-8
During the study conduct it was observed that the levels of IL-17, measured in both blood and sputum were below limit of quantification; for neutrophil elastase, in sputum no inference could be made as most levels were above the limit of quantification. Thus due to limited amount of data the analysis was not summarized.
Measured: Day 1 and Day 12
Asthma Control Questionnaire (ACQ) Assessment
ACQ measures the adequacy of asthma control. It includes 5 questions about symptoms of asthma, 1 question about the rescue medication used and 1 about lung function (FEV1% predicted). This is a 7-item scale where the items are equally weighted and the ACQ score is the mean of 7 items which ranges from 0 to 6. 0= Well controlled and 6=extremely poorly controlled. Mean scores of =<0.75 indicate well-controlled asthma, scores between 0.76 and < 1.5 indicate partly controlled asthma, and a score >= 1.5 indicates uncontrolled asthma. Thus for ACQ a higher score indicates severe disease and a low score indicative of less severe disease.
Measured: At Day 1, Day 5 to 7 and Day 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2009 (estimated)
- Study start26 Jun 2009
- Primary completion2 Jun 2010
- Study completion2 Jun 2010
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.
- 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
- 7 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
- NCT00850642
- Sponsor's protocol ID
- 112046
- Other IDs
- 2008-007244-33, 2008
- Status last verified
- Nov 2020
- First submitted
- 24 Feb 2009
- Last updated
- 30 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Orally Administered GSK2190915 as an add-on to Current Therapy in Subjects With Moderate to Severe Asthma Who Have Elevated Sputum Neutrophils
- ClinicalTrials.gov ID
- NCT00850642
- Acronym / sponsor ID
- 112046
- Conditions
- Asthma
- Keywords
- Sputum cell counts, Neutrophils, Severe Asthma, ICS, Inhaled corticosteroids
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 7 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2009 (actual)
- Primary completion
- 2 Jun 2010 (actual)
- Study completion
- 2 Jun 2010 (actual)
- First posted
- 25 Feb 2009 (estimated)
- Results
- Posted 1 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomised, double-blind, placebo-controlled, parallel group study to evaluate the effect of treatment with GSK2190915, a FLAP inhibitor, as add-on to current inhaled corticosteroid therapy in patients with moderate to severe asthma with elevated sputum neutrophils.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: Placebo12 day repeat dosing with placebo |
| GSK2190915 100mg | Experimental | Drug: GSK2190195 100mg12 day repeat dosing treatment phase with 100mg GSK2190915. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- A subject will be eligible for inclusion in this study only if all of the following criteria apply:
- Males and females aged 18 to 65 years inclusive.
- Body mass index within the range 18.5-37.0 kilograms/metre2 (kg/m2).
- An established clinical history of Asthma in accordance with the definition by the GINA Guidelines [GINA, 2006]. Subjects should have at screening or within the last year documented reversibility (>12 %) to short acting bronchodilator, or positive methacholine challenge, or positive histamine challenge (PC20 <8mg/ml).
- A female subject is eligible to participate if she is of: non-childbearing potential defined as pre-menopausal females with documented (medical report verification) hysterectomy or double oophrectomy or postmenopausal defined as 12 months of spontaneous amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels > 40 mIU/mL and estradiol < 40 pg/ml (<140 pmol/L) or 6 weeks postsurgical bilateral oophorectomy with or without hysterectomy; childbearing potential and agrees to use one of the contracception methods listed in Section 8.1 for an appropriate period of time prior to the start of dosing and until 3 months after last dose.
Key exclusion criteria (21 listed)
- A subject will not be eligible for inclusion in this study if any of the following criteria apply:
- Past or present disease, which as judged by the investigator or medical monitor, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, gastrointestinal disease, hepatic disease, renal disease, haematological disease, neurological disease, endocrine disease or pulmonary disease (excluding asthma but including but not confined to chronic bronchitis, emphysema, bronchiectasis, eosinophilic bronchitis or pulmonary fibrosis).
- Clinically significant abnormalities in safety laboratory analysis at screening.
- Subject has uncontrolled hypertension or is hypertensive at screening. Hypertension at screening is defined as persistent systolic BP >150 mmHg or diastolic BP > 90mmHg.
- History of asthma exacerbations or acute intercurrent respiratory illness (viral respiratory syndrome, bronchitis, pneumonia) for a four week period before the screening visit
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 |
|---|---|---|
| GSK2190195 100mgGSK2190915 is a high affinity 5-lipoxygenase-activating protein (FLAP) inhibitor. | Drug | GSK2190915 100mg |
| PlaceboPlacebo : 2% (w/w) Ethanol, sucralose (5 mg/100 mL of oral solution) to 100 % (w/w) aqueous sodium carbonate buffer (0.010 M, pH 9-10) | Drug | Placebo |
Primary outcome
The Numbers of Neutrophils in Induced Sputum-Absolute Neutrophil Count
Time frame: Day -9 to -7, Day 1, Day 12 and follow-up (Day 24-28)
The neutrophils play an important role in participants with more severe asthma. The reduction in number of neutrophils in induced sputum was evaluated to study the effect of treatment with repeat oral doses of GSK2190915, in asthma participants. Sputum samples were evaluated at central laboratory. The samples were rejected, if the weight was less than 100 grams (g), or if excessive cell degeneration or due to excessive squamous cells and insufficient inflammatory cells. The total cell count of neutrophil was reported as total cell count × 10^6 /g.
Percentage of Neutrophils in Induced Sputum
Time frame: Day -9 to -7, Day 1, Day 12 and follow-up (Day 24-28)
The neutrophils play an important role in participants with more severe asthma. The reduction in number of neutrophils in induced sputum was evaluated to study the effect of treatment with repeat oral doses of GSK2190915, in asthma participants. Sputum samples were evaluated at central laboratory. The samples were rejected, if the weight was less than 100 g, or if excessive cell degeneration or due to excessive squamous cells and insufficient inflammatory cells. The total cell count of neutrophil was reported as percentage of cells.
13 secondary outcomes
Assessment of FEV1 on Visit 2, 3 and Visit 4
Time frame: Visit 2 (Day 1), visit 3 (Day 5 to 7) and visit 4 (Day 12)
Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From visit 1 (Day -7 to Day -9) to upto follow-up (upto Day 28)
Number of Participants With Vital Sign of Potential Clinical Concern (PCC)
Time frame: Visit 2 (Day 1) to Upto follow-up (Day 28)
Number of Participants With Abnormal Electrocardiogram (ECG) Findings
Time frame: Visit 2 (Day 1) to Upto follow-up (Day 28)
Number of Participants With Clinical Chemistry Values of PCC
Time frame: Visit 2 (Day 1) to Upto follow-up (Day 28)
Number of Participants With Hematology Values of PCC
Time frame: Visit 2 (Day 1) to Upto follow-up (Day 28)
Plasma Concentration of GSK2190915
Time frame: At Day 1, pre-dose; Day 1, 2 hour; Day 12, pre-dose; and Day 12, 2 hour
Percentage Change From Baseline Urine LTE4 Biomarker
Time frame: Day 1 and Day 12
Percentage Change From Baseline of LTB4 Biomarker in Plasma
Time frame: Day 1 and Day 12
Concentration of LTB4 in Sputum
Time frame: Day 1 and Day 12
Concentration of Interleukin (IL)-17 and High-sensitivity C-reactive Protein (hsCRP) in Blood
Time frame: Day 1 and Day 12
Assessment of Established Markers of Anti-inflammatory Activity in Sputum: the Measurements Will Include IL-17, Neutrophil Elastase, Myeloperoxidase and IL-8
Time frame: Day 1 and Day 12
Asthma Control Questionnaire (ACQ) Assessment
Time frame: At Day 1, Day 5 to 7 and Day 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK2190195 100mg in people with Asthma, run by GlaxoSmithKline at 8 sites in 2 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 12 inclusion and 21 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: stopped early, as of the sponsor's last update on 30 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Canada, United Kingdom. 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 1 Mar 2018). 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?
The Numbers of Neutrophils in Induced Sputum-Absolute Neutrophil Count (time frame: Day -9 to -7, Day 1, Day 12 and follow-up (Day 24-28)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Nov 2020.