AsthmaPhase 2NCT01245426
A Study in Asthmatics to Determine the Efficacy and Dose Response of Repeat Doses of GW870086X on Forced Expiratory Volume in 1 Second (FEV1)
A Phase 2 study testing GW870086 2mg, GW870086 4mg and GW870086 1mg in people with Asthma, run by GlaxoSmithKline at 11 sites in 3 countries.
Trial summary
This is a randomised, double-blind, placebo-controlled, parallel group study to determine the efficacy of twenty-seven day- repeat inhaled daily doses of GW870086X on forced expiratory volume in 1 second (FEV1). Initially there will be 3 treatment arms; placebo, 2mg GW870086X and 4mg GW870086X. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- GW870086 2mg, GW870086 4mg and GW870086 1mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 136 participants
- Where
- 11 sitesin 3 countries
- Study dates
- Dec 2010to Aug 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female between 18 and 65 years
- A female subject is eligible to participate if she is of: Non-childbearing potential. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment.
- Male subjects must agree to use one of the protocol contraception methods.
- Body weight, men ≥ 50 kg, women ≥ 45 kg and BMI within the range 18.5 - 29.0 kg/m2 (inclusive).
- Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta-2 agonist therapy
- Severity of Disease: A best FEV1 of 60%-85% of the predicted normal value during the Visit 1 screening period.
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- No history of smoking within 6 months of the start of the study and with a total pack year history of ≤10 pack years
- Capable of giving written informed consent
- Single QTcB or QTcF < 450 msec; or QTc < 480 msec in subjects with Bundle Branch Block.
- AST and ALT < 2xULN; alkaline phosphatase and bilirubin ≤ 1.5xULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Who cannot join
- A positive test for Hepatitis B or Hepatitis C antibody.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
- The subject has a positive pre-study drug/alcohol screen unless a positive can be explained by the patients' medication.
- Past or present disease, which as judged by the investigator, may affect the outcome of this study.
- Clinically significant abnormalities in safety laboratory analysis at screening, as determined by the investigator.
- Subject is hypertensive at screening.
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- History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures.
- Administration of oral, injectable or dermal steroids within 8 weeks of screening.
- Exacerbation of asthma within 4 weeks prior to the first dose of study medication.
- Respiratory Infection that is not resolved within the 4 weeks before screening and led to a change in asthma management, or in the opinion of the Investigator is expected to affect the subjects asthma status or the subjects ability to participate in the study.
- Any asthma exacerbation requiring oral corticosteroids within 8 weeks of screening. A subject must not have had any hospitalisation for asthma within 6 months prior to screening
- A positive test for HIV antibody.
- History of regular alcohol consumption within 6 months of the study.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
- Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
- Use of prescription or non-prescription drugs within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety. Paracetamol is an exception and will be permitted at daily doses of up to 4 g from screening to follow-up.
- Has taken Xanthines (including theophylline, but not including caffeine), anticholinergics, cromoglycates and/or long-acting beta-2 agonists within 1 week prior to screening and is unable to abstain from them throughout the study.
- Unable to abstain from other medications other than short acting inhaled beta-2 agonists and paracetamol (up to 4 g per day) 7 days before screening until the follow-up visit.
- Unable to abstain from medication or supplements that significantly inhibit the cytochrome P450 subfamily enzyme CYP3A4, from screening and throughout the study.
- Unable to use the DISKHALER® device correctly.
- History of sensitivity to any of the study medications.
- Where participation in the study would result in donation of blood or blood products in excess of 500 ml within a 56 day period.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- The subject is not able to understand or comply with protocol requirements, instructions and protocol stated restrictions.
- Vulnerable subjects.
- Subject is mentally or legally incapacitated.
- Urinary cotinine levels indicative of smoking or history within 6 months prior to screening.
- Consumption of red wine, seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
Trial locations and contacts
11 sites in 3 countries.
11 sites in 3 countries
Germany7 sites
GSK Investigational Site
Berlin, State of Berlin, 10969
GSK Investigational Site
Berlin, State of Berlin, 14050
GSK Investigational Site
Frankfurt am Main, Hesse, 60596
GSK Investigational Site
Hamburg, Free and Hanseatic City of Hamburg, 20354
GSK Investigational Site
Hanover, Lower Saxony, 30625
GSK Investigational Site
Lübeck, Schleswig-Holstein, 23552
GSK Investigational Site
Magdeburg, Saxony-Anhalt, 39112
South Africa3 sites
GSK Investigational Site
Bloemfontein, 9301
GSK Investigational Site
George, 6529
GSK Investigational Site
Newton Park, Port Elizabeth, 6045
About this study
Official title: A Phase II Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Study to Determine the Efficacy and Dose Response of Repeat Inhaled Doses of GW870086X on FEV1 in Adults With Persistent Asthma
This is a randomised, double-blind, placebo-controlled, parallel group study to determine the efficacy of twenty-seven day- repeat inhaled daily doses of GW870086X on forced expiratory volume in 1 second (FEV1). Initially there will be 3 treatment arms; placebo, 2mg GW870086X and 4mg GW870086X. After an interim analysis the trial may; continue to completion using the original doses, be terminated early, or have a fourth arm added of either 1mg GW870086X once daily or 3mg GW870086X once daily.
Read the detailed description
This is a randomised, double-blind, placebo-controlled, parallel group study to determine the efficacy of twenty-seven day- repeat inhaled doses of GW870086X on FEV1. GW870086X is a novel inhaled corticosteroid with potent glucocorticoid activity currently in development by GlaxoSmithKline (GSK) as an inhaled treatment of persistent asthma. Initially, subjects will be randomised to receive placebo, 2mg or 4mg GW870086X once daily. An interim analysis will be performed on the primary endpoint to potentially adapt the study design after approximately 45 subjects have completed dosing. Based on the results of the interim analysis, the trial may continue to completion using the original doses or an adaptation to the doses could be made. Either the 1mg GW870086X once daily arm or 3mg GW870086X once daily arm may be added, or the trial could be terminated early. After screening there will be a 4 week run in period prior to start of treatment and after will be a follow up period 1-2 weeks after last dose. Approximately 120 subjects will complete the study. Key safety assessments include; clinical laboratory tests, vital signs and collection of adverse events (AE's).
- Conditions
- Asthma
- Being tested
- GW870086 2mg, GW870086 4mg, GW870086 Placebo, GW870086 1mg, GW870086 3mg
- Keywords
- Asthma, GW870086, Efficacy, FEV1
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GW870086 2mgDrug
oral inhalation
GW870086 4mgDrug
oral inhalation
GW870086 PlaceboDrug
oral inhalation
GW870086 1mgDrug
oral inhalation
GW870086 3mgDrug
oral inhalation
| Study group | Role | What they receive |
|---|---|---|
| GW870086 2mg | Experimental | GW870086 2mg once daily in the morning for 27 ± 2 days Receives: Drug: GW870086 2mg |
| GW870086 4mg | Experimental | GW870086 4mg once daily in the morning for 27 ± 2 days Receives: Drug: GW870086 4mg |
| Placebo | Placebo comparator | Placebo once daily in the morning for 27 ± 2 days Receives: Drug: GW870086 Placebo |
| GW870086 1mg | Experimental | GW870086 1mg once daily in the morning for 27 ± 2 days Receives: Drug: GW870086 1mg |
| GW870086 3mg | Experimental | GW870086 3mg once daily in the morning for 27 ± 2 days Receives: Drug: GW870086 3mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline associated with GW870086X versus placebo at Day 28 on FEV1
Measured: Day 28
Secondary outcomes (4)
Change from baseline in FEV1 on Day 7, Day 14 and Day 21
Measured: Days; 7, 14, 21
Change from baseline in peak expiratory flow rate (PEFR) measured twice daily over 28 days
Measured: Days 1-28
Rescue medication usage
Measured: Days 1-28
Assessment of vital signs, safety laboratory parameters and incidences of adverse events throughout treatment period
Measured: 9-10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2010 (estimated)
- Study startDec 2010
- Primary completionJul 2011
- Study completionAug 2011
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 136 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
- NCT01245426
- Sponsor's protocol ID
- 114749
- Status last verified
- Nov 2016
- First submitted
- 19 Nov 2010
- Last updated
- 1 Dec 2016
- Results posted
- No
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Randomised, Double-Blind, Placebo-Controlled, Parallel Group, Multicentre Study to Determine the Efficacy and Dose Response of Repeat Inhaled Doses of GW870086X on FEV1 in Adults With Persistent Asthma
- ClinicalTrials.gov ID
- NCT01245426
- Acronym / sponsor ID
- 114749
- Conditions
- Asthma
- Keywords
- Asthma, GW870086, Efficacy, FEV1
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 22 Nov 2010 (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.
This is a randomised, double-blind, placebo-controlled, parallel group study to determine the efficacy of twenty-seven day- repeat inhaled daily doses of GW870086X on forced expiratory volume in 1 second (FEV1). Initially there will be 3 treatment arms; placebo, 2mg GW870086X and 4mg GW870086X. After an interim analysis the trial may; continue to completion using the original doses, be terminated early, or have a fourth arm added of either 1mg GW870086X once daily or 3mg GW870086X once daily.
Detailed description
This is a randomised, double-blind, placebo-controlled, parallel group study to determine the efficacy of twenty-seven day- repeat inhaled doses of GW870086X on FEV1. GW870086X is a novel inhaled corticosteroid with potent glucocorticoid activity currently in development by GlaxoSmithKline (GSK) as an inhaled treatment of persistent asthma. Initially, subjects will be randomised to receive placebo, 2mg or 4mg GW870086X once daily. An interim analysis will be performed on the primary endpoint to potentially adapt the study design after approximately 45 subjects have completed dosing. Based on the results of the interim analysis, the trial may continue to completion using the original doses or an adaptation to the doses could be made. Either the 1mg GW870086X once daily arm or 3mg GW870086X once daily arm may be added, or the trial could be terminated early. After screening there will be a 4 week run in period prior to start of treatment and after will be a follow up period 1-2 weeks after last dose. Approximately 120 subjects will complete the study. Key safety assessments include; clinical laboratory tests, vital signs and collection of adverse events (AE's).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| GW870086 2mg | Experimental | Drug: GW870086 2mgGW870086 2mg once daily in the morning for 27 ± 2 days |
| GW870086 4mg | Experimental | Drug: GW870086 4mgGW870086 4mg once daily in the morning for 27 ± 2 days |
| Placebo | Placebo comparator | Drug: GW870086 PlaceboPlacebo once daily in the morning for 27 ± 2 days |
| GW870086 1mg | Experimental | Drug: GW870086 1mgGW870086 1mg once daily in the morning for 27 ± 2 days |
| GW870086 3mg | Experimental | Drug: GW870086 3mgGW870086 3mg once daily in the morning for 27 ± 2 days |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female between 18 and 65 years
- A female subject is eligible to participate if she is of: Non-childbearing potential. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to discontinue HRT to allow confirmation of post-menopausal status prior to study enrollment.
- Male subjects must agree to use one of the protocol contraception methods.
- Body weight, men ≥ 50 kg, women ≥ 45 kg and BMI within the range 18.5 - 29.0 kg/m2 (inclusive).
- Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta-2 agonist therapy
Key exclusion criteria (28 listed)
- A positive test for Hepatitis B or Hepatitis C antibody.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities
- The subject has a positive pre-study drug/alcohol screen unless a positive can be explained by the patients' medication.
- Past or present disease, which as judged by the investigator, may affect the outcome of this study.
- Clinically significant abnormalities in safety laboratory analysis at screening, as determined by the investigator.
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 |
|---|---|---|
| GW870086 2mgoral inhalation | Drug | GW870086 2mg |
| GW870086 4mgoral inhalation | Drug | GW870086 4mg |
| GW870086 Placebooral inhalation | Drug | Placebo |
| GW870086 1mgoral inhalation | Drug | GW870086 1mg |
| GW870086 3mgoral inhalation | Drug | GW870086 3mg |
Primary outcome
Change from baseline associated with GW870086X versus placebo at Day 28 on FEV1
Time frame: Day 28
4 secondary outcomes
Change from baseline in FEV1 on Day 7, Day 14 and Day 21
Time frame: Days; 7, 14, 21
Change from baseline in peak expiratory flow rate (PEFR) measured twice daily over 28 days
Time frame: Days 1-28
Rescue medication usage
Time frame: Days 1-28
Assessment of vital signs, safety laboratory parameters and incidences of adverse events throughout treatment period
Time frame: 9-10 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2016.
- 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
11 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GW870086 2mg, GW870086 4mg and GW870086 1mg in people with Asthma, run by GlaxoSmithKline at 11 sites in 3 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 10 inclusion and 28 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 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Germany, South Africa, Bulgaria. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline associated with GW870086X versus placebo at Day 28 on FEV1 (time frame: Day 28). 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 1 Dec 2016.