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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00368576
First received: August 22, 2006
Last updated: March 15, 2012
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
Asthma
Atherosclerosis
Drug: SB 480848, tablets
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Diagnostic
Official Title: A Randomised, Double-blind, Placebo-controlled, Parallel Group, Repeat Dose Study to Assess the Effect of SB-480848 on Overall Asthma Control in Adult Subjects With Persistent Asthma Controlled on Stable, Low-dose, Inhaled Corticosteroids

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • FEV1 [ Time Frame: 6 hours post-dose, Days 7, 14 and 21 ]

Secondary Outcome Measures:
  • Methacholine challenge Amounts of certain chemicals/proteins in blood Amount of drug in the blood [ Time Frame: before dosing and after 21 days of dosing ]
  • Measurements of FEV1 following single doses of SB-480848 and placebo.
  • Measurements of PC20 on Day 21 +24hrs after dosing with SB-480848 and placebo. [ Time Frame: Day 21 +24hrs after dosing ]
  • Blood drug levels of SB-553253 [metabolite of SB-480848] may be assessed, as appropriate.
  • Urinary leukotriene concentrations after 21 days of dosing with SB-480848 and Placebo. [ Time Frame: after 21 days ]
  • Blood levels of LpPLA2 and CD62 concentrations over 21-day dosing period with SB-480848 and placebo [ Time Frame: over 21-day dosing period ]
  • Measurements of FEF25-75 and peak expiratory flow following single and repeat oral doses of SB-480848.
  • Assessment of vitals, ECGs, safety labs and number of puffs of rescue inhaled, short-acting β2-agonists taken, asthma-related symptoms and night time awakenings, number of subjects withdrawn due to worsening of asthma on SB- 480848 and placebo.

Enrollment: 67
Study Start Date: August 2006
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: SB 480848, tablets
    Other Names:
    • SB 480848
    • tablets
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368576

Locations
United States, California
GSK Investigational Site
Cypress, California, United States, 90630
United States, Illinois
GSK Investigational Site
Normal, Illinois, United States, 61761
United States, Massachusetts
GSK Investigational Site
North Dartmouth, Massachusetts, United States, 02747
United States, South Carolina
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Germany
GSK Investigational Site
Neu-ulm, Bayern, Germany, 89231
GSK Investigational Site
Grosshansdorf, Schleswig-holstein, Germany, 22927
GSK Investigational Site
Berlin, Germany, 14050
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00368576     History of Changes
Other Study ID Numbers: LPL107629
Study First Received: August 22, 2006
Last Updated: March 15, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
SB-480848
methacholine challenge
asthma
inhaled steroid

Additional relevant MeSH terms:
Asthma
Atherosclerosis
Arteriosclerosis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on August 21, 2014