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

NCT00368576 | Completed Phase 1

• 1 other identifier: LPL107629
• Study Type: interventional
• Target: 67
• Locations: 2 countries
• Sites: 7

Brief Summary

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

Conditions

Atherosclerosis

Keywords

SB-480848; methacholine challenge; asthma; inhaled steroid

Outcome Measures

Primary Outcomes (1)

• FEV1

  6 hours post-dose, Days 7, 14 and 21

Secondary Outcomes (8)

• Methacholine challenge Amounts of certain chemicals/proteins in blood Amount of drug in the blood

  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.

  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.

  after 21 days

Interventions

SB 480848, tablets DRUG

Also known as: SB 480848, tablets

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (7)

GSK Investigational Site

Cypress, California, 90630, United States

Location

GSK Investigational Site

Normal, Illinois, 61761, United States

Location

GSK Investigational Site

North Dartmouth, Massachusetts, 02747, United States

Location

GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

GSK Investigational Site

Neu-Ulm, Bavaria, 89231, Germany

Location

GSK Investigational Site

Großhansdorf, Schleswig-Holstein, 22927, Germany

Location

GSK Investigational Site

Berlin, State of Berlin, 14050, Germany

Location

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Atherosclerosis; Asthma

Interventions

darapladib; Tablets

Condition Hierarchy (Ancestors)

Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dosage Forms; Pharmaceutical Preparations

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 22, 2006
• First Posted: August 24, 2006
• Study Start: August 1, 2006
• Primary Completion: October 1, 2007
• Study Completion: October 1, 2007
• Last Updated: December 5, 2016

Record last verified: 2016-12

Data Sharing

• IPD Sharing: Will share

Locations

DE (3); US (4)