Clinical trial NCT00380354: Study To Evaluate GSK256066 In Subjects With Mild Bronchial Asthma
Official title: A Two-centre, Randomised, Double-blind, Placebo-controlled, 2-period Cross-over Study to Evaluate the Effect of Treatment With Repeat Doses of Inhaled GSK256066 on the Allergen-induced Late Asthmatic Response in Subjects With Mild Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Mild Asthma
Keywords: allergen
methacholine
GSK256066
mild asthmatics
repeat dose
challenge
late asthmatic response
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2006-09-25
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria

* 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.

Exclusion criteria:

* 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.

Primary outcomes:
measure: Asthmatic response
timeFrame: after 7 days of treatment
Secondary outcomes:
measure: FEV1 Concentration of exhaled nitric oxide
timeFrame: on day 8 of each treatment period
measure: Incidence of treatment emergent adverse events
timeFrame: throughout study
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
state: Lancashire
city: London
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.