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Status:

COMPLETED

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

Lead Sponsor:

GlaxoSmithKline

Conditions:

Atherosclerosis

Eligibility:

All Genders

18-65 years

Phase:

PHASE1

Brief Summary

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

Eligibility Criteria

Inclusion

  • Inclusion Criteria:
  • 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.
  • Exclusion criteria:
  • 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

Exclusion

    Key Trial Info

    Start Date :

    August 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    October 1 2007

    Estimated Enrollment :

    67 Patients enrolled

    Trial Details

    Trial ID

    NCT00368576

    Start Date

    August 1 2006

    End Date

    October 1 2007

    Last Update

    December 5 2016

    Active Locations (7)

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    Page 1 of 2 (7 locations)

    1

    GSK Investigational Site

    Cypress, California, United States, 90630

    2

    GSK Investigational Site

    Normal, Illinois, United States, 61761

    3

    GSK Investigational Site

    North Dartmouth, Massachusetts, United States, 02747

    4

    GSK Investigational Site

    Spartanburg, South Carolina, United States, 29303