AsthmaPhase 2NCT00445510
This Study Will Examine the Effects of GSK256066 to Protect Mild Steroid-naive Asthmatics Against an Antigen Challenge
A Phase 2 study testing GSK256066 in people with Asthma, run by GlaxoSmithKline at 1 site in New Zealand.
Trial summary
This will be a single centre, randomised, double-blind, placebo-controlled, 2-period crossover study to investigate the effect of treatment with repeat inhaled doses of GSK256066 on bronchial hyper-reactivity to adenosine monophosphate. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Asthma
- What is being tested?
- GSK256066
- How many people
- 24 participants
- Where
- 1 siteNew Zealand
- Study dates
- Jun 2006to not given
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Males and females aged 18 to 55 years 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 -agonist therapy by inhalation.
- Pre-bronchodilator FEV1 >75% of predicted at screening.
- Documented sensitivity to AMP with a provocative concentration of AMP resulting in a 20% fall in FEV1 (PC20 AMP) of <80 mg/ml at the screening visit.
- Demonstrate stable bronchoconstriction in response to inhaled AMP at the run-in visit. 'Stable bronchoconstriction' is a term to define a population of asthmatics who have a repeatable and reproducible response to a challenge agent that induces bronchoconstriction. The run-in PC20 needs to be within 1.25DD of the screening PC20.
- Non-smoking status as verified by urinary cotinine levels below 300 ng/mL cotinine at the screening visit. This can include ex-smokers who have given up smoking for >6 months and have less than a 5 pack-year smoking history.
- Able and willing to give written informed consent to take part in the study.
- Available to complete all study measurements.
Who cannot join
- Pregnant or nursing females.
- Past or present disease, which as judged by the investigator, may affect the outcome of this study.
- Subject has known history of hypertension or is hypertensive at screening.
- Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication.
- 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.
- Unable to abstain from prescription medication, other than short acting inhaled beta-agonists and paracetamol for the treatment of minor ailments eg headache from 48h before the first dose until the follow-up visit.
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- The subject has participated in a clinical trial during the previous 3 months.
- History of blood donation (450 mL) within 2 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.
- The subject has tested positive for hepatitis C antibody or hepatitis B surface antigen or HIV antibodies.
- The subject has positive drugs of abuse test.
- Subjects weighing less than 50kg are to be excluded from participating in the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double Blind, Placebo Controlled, Repeat Dose Study to Determine the Effect of GSK256066 87.5 Mcg to Protect Against AMP Challenge in the Lung in Mild Steroid-naive Asthmatics.
This will be a single centre, randomised, double-blind, placebo-controlled, 2-period crossover study to investigate the effect of treatment with repeat inhaled doses of GSK256066 on bronchial hyper-reactivity to adenosine monophosphate.
- Conditions
- Asthma
- Being tested
- GSK256066
- Keywords
- GSK256066,, allergen,, challenge,, repeat dose,, AMP,, mild asthmatics
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GSK256066Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
AMP PC20: GSK256066 7 days of 87.5mcg vs placebo 2hrs post-dose on Day 7.
Secondary outcomes (1)
AMP PC20: GSK256066 7 days of 87.5mcg vs placebo 24hrs post-dose on Day 7. Exhaled Nitric Oxide: GSK256066 7 days of 87.5mcg vs placebo at Day 1; 1hr and 2hr, Day 7; 1hr, 2hr and 24hr.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2007 (estimated)
- Study startJun 2006
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
- Crossover
- Masking
- Double blind
- Enrolment
- 24 participants
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
- NCT00445510
- Sponsor's protocol ID
- IPA106620
- Status last verified
- Feb 2011
- First submitted
- 7 Mar 2007
- Last updated
- 4 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double Blind, Placebo Controlled, Repeat Dose Study to Determine the Effect of GSK256066 87.5 Mcg to Protect Against AMP Challenge in the Lung in Mild Steroid-naive Asthmatics.
- ClinicalTrials.gov ID
- NCT00445510
- Acronym / sponsor ID
- IPA106620
- Conditions
- Asthma
- Keywords
- GSK256066,, allergen,, challenge,, repeat dose,, AMP,, mild asthmatics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- First posted
- 9 Mar 2007 (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 will be a single centre, randomised, double-blind, placebo-controlled, 2-period crossover study to investigate the effect of treatment with repeat inhaled doses of GSK256066 on bronchial hyper-reactivity to adenosine monophosphate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Males and females aged 18 to 55 years 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 -agonist therapy by inhalation.
- Pre-bronchodilator FEV1 >75% of predicted at screening.
- Documented sensitivity to AMP with a provocative concentration of AMP resulting in a 20% fall in FEV1 (PC20 AMP) of <80 mg/ml at the screening visit.
- Demonstrate stable bronchoconstriction in response to inhaled AMP at the run-in visit. 'Stable bronchoconstriction' is a term to define a population of asthmatics who have a repeatable and reproducible response to a challenge agent that induces bronchoconstriction. The run-in PC20 needs to be within 1.25DD of the screening PC20.
Key exclusion criteria (12 listed)
- Pregnant or nursing females.
- Past or present disease, which as judged by the investigator, may affect the outcome of this study.
- Subject has known history of hypertension or is hypertensive at screening.
- Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication.
- 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.
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 |
|---|---|---|
| GSK256066 | Drug | – |
Primary outcome
AMP PC20: GSK256066 7 days of 87.5mcg vs placebo 2hrs post-dose on Day 7.
1 secondary outcome
AMP PC20: GSK256066 7 days of 87.5mcg vs placebo 24hrs post-dose on Day 7. Exhaled Nitric Oxide: GSK256066 7 days of 87.5mcg vs placebo at Day 1; 1hr and 2hr, Day 7; 1hr, 2hr and 24hr.
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 4 Jun 2012.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GSK256066 in people with Asthma, run by GlaxoSmithKline at 1 site in New Zealand.
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 12 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 4 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in New Zealand. 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?
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?
AMP PC20: GSK256066 7 days of 87.5mcg vs placebo 2hrs post-dose on Day 7.. 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 4 Jun 2012.