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AtherosclerosisPhase 1NCT00368576

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

A Phase 1 study testing SB 480848, tablets in people with Atherosclerosis, run by GlaxoSmithKline at 7 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Atherosclerosis
What is being tested?
SB 480848, tablets
Type of treatment
Pill or oral medicine
How many people
67 participants
Where
7 sitesin 2 countries
Study dates
Aug 2006to Oct 2007
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

7 sites in 2 countries.

7 sites in 2 countries

United States4 sites

  • GSK Investigational Site

    Cypress, California, 90630

  • GSK Investigational Site

    Normal, Illinois, 61761

  • GSK Investigational Site

    North Dartmouth, Massachusetts, 02747

  • GSK Investigational Site

    Spartanburg, South Carolina, 29303

Other trials in United States

Germany3 sites

  • GSK Investigational Site

    Berlin, State of Berlin, 14050

  • GSK Investigational Site

    Großhansdorf, Schleswig-Holstein, 22927

  • GSK Investigational Site

    Neu-Ulm, Bavaria, 89231

Other trials in Germany

About this study

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

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

Conditions
Atherosclerosis
Being tested
SB 480848, tablets
Keywords
SB-480848, methacholine challenge, asthma, inhaled steroid
Medical subject headings
Atherosclerosis, Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SB 480848, tabletsDrug

    Also called SB 480848, tablets

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. FEV1

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

Secondary outcomes (8)

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

    Measured: before dosing and after 21 days of dosing

  2. Measurements of FEV1 following single doses of SB-480848 and placebo.

  3. Measurements of PC20 on Day 21 +24hrs after dosing with SB-480848 and placebo.

    Measured: Day 21 +24hrs after dosing

  4. Blood drug levels of SB-553253 [metabolite of SB-480848] may be assessed, as appropriate.

  5. Urinary leukotriene concentrations after 21 days of dosing with SB-480848 and Placebo.

    Measured: after 21 days

  6. Blood levels of LpPLA2 and CD62 concentrations over 21-day dosing period with SB-480848 and placebo

    Measured: over 21-day dosing period

  7. Measurements of FEF25-75 and peak expiratory flow following single and repeat oral doses of SB-480848.

  8. 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Aug 2006 (estimated)
  2. Study startAug 2006
  3. Primary completionOct 2007
  4. Study completionOct 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Enrolment
67 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00368576
Sponsor's protocol ID
LPL107629
Status last verified
Dec 2016
First submitted
22 Aug 2006
Last updated
5 Dec 2016
Results posted
No
Data monitoring committee
No
Individual data sharing
Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing SB 480848, tablets in people with Atherosclerosis, run by GlaxoSmithKline at 7 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FEV1 (time frame: 6 hours post-dose, Days 7, 14 and 21). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00368576.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2016.

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