AsthmaPhase 2NCT01286844

GSK2190915 Pediatric Study

A Phase 2 study testing GSK2190915A 5mg, GSK2190915A 10mg and GSK2190915A 25mg in people with Asthma, run by GlaxoSmithKline.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 1 year to 11 years
Conditions the study is for: Asthma
What is being tested?: GSK2190915A 5mg, GSK2190915A 10mg and GSK2190915A 25mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: Nov 2010to May 2011
Phase: Phase 2
Are there results?: None posted in the registry

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 1 year to 11 years
All sexes
No healthy volunteers
Child

Who may be able to join

Male and pre-menarchial female subjects aged 1to <12 years at screening are eligible for this study.
Investigator diagnosed history of asthma.
Subject weight a minimum of 11kg and above the 10th percentile for their age.
Patients must be controlled on any existing asthma treatment or currently stable off treatment, at screening.
Apart from asthma, eczema and rhinitis, subjects should be healthy and suffer from no other significant medical conditions.
Subjects and parents/guardians must be able to understand and comply with protocol requirements, instructions and protocol-stated restrictions. Parents/guardians must have the ability to read and write.
A signed and dated informed consent from at least one parent/guardian, and, for subjects ≥ 7 years old an accompanying informed assent from the subject prior to admission to the study.
AST and ALT < 2xULN.

Who cannot join

Subjects who have changed their asthma medication, dose or regime within 4 weeks of screening
Administration of anti -leukotriene therapies for 14 days before screening and during the study.
Any medical condition or circumstance making the volunteer unsuitable for participation in the study.
Any clinically relevant abnormality identified on the screening medical assessment.
Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of screening and led to a change in asthma management.
Administration of any vaccinations within 2 weeks of screening or during the study

Show all 11Show fewer

Parent/guardian has history of psychiatric disease, intellectual deficiency, substance abuse, or other condition which will limit the validity of consent to participate in this study.
Any adverse reaction including immediate or delayed hypersensitivity to any component of study drug
A subject will not be eligible for this study if he/she is an immediate family member of the participating Investigator, sub-Investigator, study coordinator, or employee of the participating Investigator.
Children who are wards of the state or government.
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.

About this study

Official title: An Open Label, Dose Escalation Study to Examine the Pharmacokinetics, Pharmacodynamics and Safety and Tolerability of Single and Repeat Oral Doses of GSK2190915 in Children Aged From 1 to 11 Years With Asthma

GSK2190915 is under development as an oral controller for the treatment of adult and pediatric asthma. This study is an open label, single and repeat dose escalation study, in children with asthma. It will investigate the pharmacokinetics of GSK2190915 in children, aged from 1 to 12 years old inclusive, to determine how the dosage regimen for GSK2190915 in a pediatric population should be adjusted to achieve approximately the same level of systemic exposure that is safe and effective in adults.

Read the detailed description

Subjects will be recruited into 2 cohorts, Cohort 1 with children from 4 years of age to less than 12 years of age and cohort 2 with children from 1 year of age to less than 4 years of age. Cohort 1 is further subdivided, dependent on a subject's weight, which enables different dosing regimens and pharmacokinetic sampling within the cohort. There are 3 scheduled Pharmacokinetic and Safety Review meetings, which enable dose adjustment and dosing in the younger subjects through the study.

Blood and urine are collected for pharmacokinetic and pharmacodynamic analysis. Safety will be assessed by measurement of heart rate, blood pressure, ECG, safety laboratory data and review of adverse events. Subjects will also perform PEF and Spirometry if assessed as capable by the study investigator.

Conditions: Asthma
Being tested: GSK2190915A 5mg, GSK2190915A 10mg, GSK2190915A 25mg, GSK2190915A 50mg, GSK2190915A 100mg
Medical subject headings: Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK2190915A 5mgDrug
Oral powder for dispersion in water
GSK2190915A 10mgDrug
Oral powder for dispersion in water
GSK2190915A 25mgDrug
Oral powder for dispersion in water
GSK2190915A 50mgDrug
Oral powder for dispersion in water
GSK2190915A 100mgDrug
Oral powder for dispersion in water

Study groups in NCT01286844
Study group	Role	What they receive
Cohort 1	Experimental	Subjects ≥4 and< 12 years. First 6 subjects included, ≥8 and< 12 yrs and weigh ≥21kg, receive 1 SD (10mg) and an 8 day RD period (100mg). Remaining subjects in cohort: Subjects < 21kg receive 2 SD periods (10mg and 50mg), Subjects > 21kg receive 2 SD periods (10mg and 50mg) and an 8 day RD (100mg) Receives: Drug: GSK2190915A 10mg; Drug: GSK2190915A 50mg; Drug: GSK2190915A 100mg
Cohort 2	Experimental	Subjects ≥1 and< 4 years, receive 2 SD (5mg and 25mg) Receives: Drug: GSK2190915A 5mg; Drug: GSK2190915A 25mg

What is being measured

The primary outcome is the main question the study is designed to answer.

Derived plasma pharmacokinetic parameters
Measured: 24 hours

Secondary outcomes (5)

Leukotriene biomarkers
Measured: 24 hours
Vital Signs
Measured: 24 hours
ECG
Measured: 24 hours
Adverse Event Monoitoring
Measured: Up to 90 days
Clinical Labs
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 2010May 2011

First posted31 Jan 2011 (estimated)
Study startNov 2010
Primary completionMay 2011 (estimated)
Study completionMay 2011 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01286844
Sponsor's protocol ID: 112361
Status last verified: Jun 2017
First submitted: 7 Oct 2010
Last updated: 7 Jun 2017
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
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RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
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Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
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All Asthma trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Dose Escalation Study to Examine the Pharmacokinetics, Pharmacodynamics and Safety and Tolerability of Single and Repeat Oral Doses of GSK2190915 in Children Aged From 1 to 11 Years With Asthma
ClinicalTrials.gov ID: NCT01286844
Acronym / sponsor ID: 112361
Conditions: Asthma
Phase: Phase 2
Study type: Interventional
Recruitment status: Withdrawn
Enrolment: 0 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Nov 2010
Primary completion: May 2011 (estimated)
Study completion: May 2011 (estimated)
First posted: 31 Jan 2011 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Cohort 1	Experimental	Drug: GSK2190915A 10mg, Drug: GSK2190915A 50mg, Drug: GSK2190915A 100mgSubjects ≥4 and< 12 years. First 6 subjects included, ≥8 and< 12 yrs and weigh ≥21kg, receive 1 SD (10mg) and an 8 day RD period (100mg). Remaining subjects in cohort: Subjects < 21kg receive 2 SD periods (10mg and 50mg), Subjects > 21kg receive 2 SD periods (10mg and 50mg) and an 8 day RD (100mg)
Cohort 2	Experimental	Drug: GSK2190915A 5mg, Drug: GSK2190915A 25mgSubjects ≥1 and< 4 years, receive 2 SD (5mg and 25mg)

Who may qualify

Ages: 1 year to 11 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (8 listed)

Male and pre-menarchial female subjects aged 1to <12 years at screening are eligible for this study.
Investigator diagnosed history of asthma.
Subject weight a minimum of 11kg and above the 10th percentile for their age.
Patients must be controlled on any existing asthma treatment or currently stable off treatment, at screening.
Apart from asthma, eczema and rhinitis, subjects should be healthy and suffer from no other significant medical conditions.

Key exclusion criteria (11 listed)

Subjects who have changed their asthma medication, dose or regime within 4 weeks of screening
Administration of anti -leukotriene therapies for 14 days before screening and during the study.
Any medical condition or circumstance making the volunteer unsuitable for participation in the study.
Any clinically relevant abnormality identified on the screening medical assessment.
Culture-documented or suspected bacterial or viral infection of the upper or lower respiratory tract, sinus or middle ear that is not resolved within 4 weeks of screening and led to a change in asthma management.

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
GSK2190915A 5mgOral powder for dispersion in water	Drug	Cohort 2
GSK2190915A 10mgOral powder for dispersion in water	Drug	Cohort 1
GSK2190915A 25mgOral powder for dispersion in water	Drug	Cohort 2
GSK2190915A 50mgOral powder for dispersion in water	Drug	Cohort 1
GSK2190915A 100mgOral powder for dispersion in water	Drug	Cohort 1

Primary outcome

Derived plasma pharmacokinetic parameters
Time frame: 24 hours

5 secondary outcomes

Leukotriene biomarkers
Time frame: 24 hours
Vital Signs
Time frame: 24 hours
ECG
Time frame: 24 hours
Adverse Event Monoitoring
Time frame: Up to 90 days
Clinical Labs
Time frame: 24 hours

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2017.

Related trials for Asthma

RecruitingObservational study
Asthma and Primary Arterial Hypertension: an Inflammatory Link?
Asthma Bronchial
RecruitingPhase 3
A Study to Learn About the Study Medicine Called Tilrekimig in People With Severe Asthma
Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 2
Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
Asthma
Active, not recruitingPhase 1
A Phase 1, Randomized, Double-blind, Placebo-controlled Study Evaluating AMG 691 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Asthma

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing GSK2190915A 5mg, GSK2190915A 10mg and GSK2190915A 25mg in people with Asthma, run by GlaxoSmithKline.

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 8 inclusion and 11 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: withdrawn, as of the sponsor's last update on 7 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Derived plasma pharmacokinetic parameters (time frame: 24 hours). 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 NCT01286844.

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 7 Jun 2017.