A Study To Determine The Effect Of SB-480848 On Asthma

Completed · Phase 1

Conditions studied: Atherosclerosis

In brief

The purpose of this study is to compare the effects of SB-480848 with placebo in subjects with asthma.

Key facts

Study ID

NCT00368576

Run by

GlaxoSmithKline

People needed

67

Starts

2006-08-01

Expected to finish

2007-10-01

Last updated by the study team

2016-12-05

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female subjects who have documented persistent asthma for at least 3 months
• Subjects must have been on a stable, low-dose ICS for a minimum of 4 weeks prior to the screening visit.
• Aged 18-65 years, at screening
• FEV1 greater than or equal to 70% predicted (ECCS, 1993)
• Subjects must show an increase in FEV1 greater than or equal to 12% (and an absolute change >200mL) within 30 minutes following inhalation of 4 puffs of albuterol/salbutamol or 1 nebulized treatment of 2.5mg or have historical, documented evidence of reversibility, within 12 months prior to screening
• Subjects must be willing to replace their inhaled, short-acting β2-agonist with study provided albuterol/salbutamol
• Patient must be capable of giving informed consent and comply with the study requirements and timetable.
• Inclusion Criteria following run in period (Prior to randomisation) Subjects will be screened based on the inclusion and exclusion criteria noted above.
• During the run-in period [Day -14 to Day 1], subjects will be asked to maintain a diary card and document the number of puffs of rescue inhaled, short-acting β2-agonists taken, asthma-related symptoms and night time awakenings as well as morning and evening PEF measurements.
• On the morning of Day 0, subjects will be eligible for randomisation into the study if all of the following criteria are met:
• Subjects required, on average less than or 2 puffs per day of study provided albuterol/ salbutamol during the last 7-day period prior to Day 0 [from Day -7 to Day 1]
• Subjects had asthma symptoms on less than or 5 out of the last 7 consecutive days of the run-in period
• FEV1 greater than or equal to 70% predicted (ECCS, 1993).
• FEV1 must be within ± 15% of the FEV1 value at beginning of screening.
• Compliance with completion of the diary card.

You may not qualify if…

• The patient has life threatening asthma. A research patient must not have been hospitalized two or more times in the last year prior to Day 0 due to asthma and must not have been hospitalized within 6 months prior to Day 0
• Subjects with daily asthma-related symptoms.
• Subjects taking any of the medications listed in the protocol for the listed interval prior to the screening visit or during the study:
• Subjects with historical or current evidence of any other disease.
• Subjects with clinically significant abnormal findings on physical exam or other screening procedures.
• Subjects who have received an investigational product within 30 days or 5 half-lives [whichever is longer] prior to the first dose of study medication
• Subjects who have tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV.
• Subjects with history of drug or alcohol abuse
• Positive drug (not related to known medications the subject is taking at time of screening), alcohol or cotinine/carbon monoxide (CO) test at screening or at Day 0
• Subjects with a history of regularly drinking more than 2 (females)/3 (males) units of alcohol a day.
• Pregnant or nursing female subjects.
• Female subjects of childbearing potential with an unwillingness to agree to one of the methods of contraception listed in the protocol.
• Subjects who suffer from any medical condition which in the opinion of the investigator would compromise patient safety or ability to comply with study procedures
• Subjects who are current smokers or have given up smoking within the previous six months or who have a smoking history > 10 pack years.
• Subjects with history of an upper or lower respiratory tract infection or symptoms (including the common cold) within 2 weeks prior to first dose of study medication
• Subjects who have donated more than 500ml of blood within 56 days prior to the first dose of study medication
• Subjects who are currently receiving potent 3A4 inhibitors be excluded.
• Subjects on β-adrenergic receptor blockers within 3 months prior to screening visit
• Subjects previously hospitalized as a result of a methacholine challenge

Where it is running

• GSK Investigational Site — Cypress, California, United States
• GSK Investigational Site — Normal, Illinois, United States
• GSK Investigational Site — North Dartmouth, Massachusetts, United States
• GSK Investigational Site — Spartanburg, South Carolina, United States
• GSK Investigational Site — Neu-Ulm, Bavaria, Germany
• GSK Investigational Site — Großhansdorf, Schleswig-Holstein, Germany
• GSK Investigational Site — Berlin, State of Berlin, Germany

Full record on ClinicalTrials.gov

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