NCT00380354

Brief Summary

This study will evaluate the efficacy and safety of GSK256066 in the treatment of subjects with mild bronchial asthma, using a number of clinical and biological markers of efficacy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2 asthma

Timeline
Completed

Started Sep 2006

Shorter than P25 for phase_2 asthma

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2006

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

June 4, 2012

Status Verified

February 1, 2011

First QC Date

September 21, 2006

Last Update Submit

May 31, 2012

Conditions

AsthmaMild Asthma

Keywords

allergenmethacholineGSK256066mild asthmaticsrepeat dosechallengelate asthmatic response

Outcome Measures

Primary Outcomes (1)

  • Asthmatic response

    after 7 days of treatment

Secondary Outcomes (2)

  • FEV1 Concentration of exhaled nitric oxide

    on day 8 of each treatment period

  • Incidence of treatment emergent adverse events

    throughout study

Interventions

GSK256066DRUG

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Documented history of bronchial asthma, first diagnosed at least 6 months prior to the screening visit and currently being treated only with intermittent short-acting beta -agonist therapy by inhalation.
  • Pre-bronchodilator FEV1 \>75% of predicted at screening.
  • Non-smoker
  • Demonstration of a positive reaction to at least one allergen from a battery of allergens (including house dust mite, grass pollen and cat hair on skin prick testing at screening, or within 12 months of study start.
  • Have Asthmatic response
  • Able and willing to give written informed consent to take part in the study.
  • Available to complete all study measurements.

You may not qualify if:

  • History of cardiovascular disease
  • Clinically significant abnormalities in safety laboratory analysis at screening including any subject who has greater than "trace urine protein levels" following urinalysis at screening.
  • History of hayfever
  • The subject has tested positive for hepatitis C antibody or hepatitis B surface antigen.
  • The subject has tested positive for HIV antibodies.
  • The subject has positive drugs of abuse test.
  • Subjects weighing less than 50kg are to be excluded from participating in the study.
  • The subject has participated in a study with a new molecular entity during the previous 3 months.
  • History of being unable to tolerate or complete methacholine, and/or allergen challenge tests.
  • There is a risk of non-compliance with study medication or study procedures.
  • History of blood donation (450 mL) within 2 months of starting the clinical study.
  • The subject regularly drinks more than 28 units of alcohol in a week if male, or 21 units per week if female. One unit of alcohol is defined as a medium (125 ml) glass of wine, half a pint (250 ml) of beer or one measure (24 ml) of spirits.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

GSK Investigational Site

Manchester, Lancashire, M23 9LT, United Kingdom

Location

GSK Investigational Site

London, SE1 9RT, United Kingdom

Location

Related Publications (1)

  • Singh D, Petavy F, Macdonald AJ, Lazaar AL, O'Connor BJ. The inhaled phosphodiesterase 4 inhibitor GSK256066 reduces allergen challenge responses in asthma. Respir Res. 2010 Mar 1;11(1):26. doi: 10.1186/1465-9921-11-26.

    PMID: 20193079DERIVED

MeSH Terms

Conditions

Asthma

Interventions

6-((3-((dimethylamino)carbonyl)phenyl)sulfonyl)-8-methyl-4-((3-methyloxyphenyl)amino)-3-quinolinecarboxamide

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2006

First Posted

September 25, 2006

Study Start

September 1, 2006

Study Completion

June 1, 2007

Last Updated

June 4, 2012

Record last verified: 2011-02

Locations

GB(2)