Bronchospasm
Conditions
Keywords
GSK615915 asthma surfactant MDI
Brief summary
GSK615915A is being developed as a novel surfactant for use in the formulation of GSK's future generation of Metered Dose Inhalers (MDIs). A surfactant in a MDI would provide a more stable drug suspension, this in turn will produce a consistent dose of drug being delivered with each puff.
Interventions
DRUGGSK615915A
GSK615915A inhaler will be given with a dose of 250 micrograms per metered actuation and 120 actuations per inhaler.
DRUGPlacebo
Subjects will also receive placebo inhaler.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Women of non-child bearing potential. * Body weight = 50 kg (110 lbs) for men and = 45 kg for women and Body Mass Index (BMI) within the range 19.0-30.0 kg/m² * The subject is a current non-smoker who has not used any tobacco products in the last 12 months with a pack history of = 10 pack years. * The subject has demonstrated the ability to correctly use a metered dose inhaler device. * If asthmatic: The subject must be clinically stable The subject has a baseline FEV1 = 80% of predicted.
Exclusion criteria
* As a result of the medical interview, physical examination or screening investigations, the Physician Responsible considers the volunteer unfit for the study. * The subject has a history of allergy to excipients, MDI propellants, or a history of drug or other allergy that, in the opinion of the physician responsible makes the volunteer unfit to participate. * The subject has recently participated in another clinical trial. * The subject has used prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John’s Wort) within 7 or 14 days. * The subject has an average weekly alcohol intake of greater than 21 units if male or 14 units if female, or an average daily intake of greater than 3 units regularly, where 1 unit is equivalent to a half-pint (220mL) of beer or 1 (25ml) measure of spirits or 1 glass (125ml) of wine. * Any history of breathing problems (e.g. history of asthmatic symptoms). * The subject is infected with the hepatitis B, hepatitis C, or HIV virus. * The subject is has a positive drugs of abuse test. * The subject has had a respiratory tract infection within 4 weeks of the start of the study. * The subject has a past or present disease, which as judged by the Doctor, may affect the outcome of this study. * The subject has a history of life-threatening asthma. * The subject has taken inhaled, nasal or dermal steroids within 4 weeks or oral steroids within 8 weeks of the start of the study. * The subject has taken long acting inhaled beta 2 agonists within 96 hours before the screening visit. * The subject has taken short acting inhaled beta 2 agonists within 8 hours before the screening visit. * The subject is unable to abstain from other drugs that may interfere with the conduct of the study or its interpretation. * The subject has ongoing rhinitis that requires treatment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Side effects Lung function Blood tests Heart rate and blood pressure Heart monitored (ECG) | Up to 18 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Levels of GSK615915A and any breakdown products in the blood and urine. | Up to 18 weeks |
Countries
United Kingdom
Outcome results
None listed