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Trial details imported from ClinicalTrials.gov
Ethics application status
This Study Will Examine the Effects of GSK256066 to Protect Mild Steroid-naive Asthmatics Against an Antigen Challenge
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.
Universal Trial Number (UTN)
Description of intervention(s) / exposure
Treatment: Drugs - GSK256066
Treatment: Drugs: GSK256066
Intervention code 
Comparator / control treatment
Primary outcome 
AMP PC20: GSK256066 7 days of 87.5mcg vs placebo 2hrs post-dose on Day 7.
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.
Key inclusion criteria
Inclusion: (All must Apply)
- 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.
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- 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
- 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.
- 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.
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
Statistical methods / analysis
Reason for early stopping/withdrawal
Accrual to date
Primary sponsor type
Ethics application status
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.
Trial related presentations / publications
GSK Clinical Trials