This Study Will Examine the Effects of GSK256066 to Protect Mild Steroid-naive Asthmatics Against an Antigen Challenge

Asthma Clinical Trial

Official title:

A Double Blind, Placebo Controlled, Repeat Dose Study to Determine the Effect of GSK256066 87.5 Mcg to Protect Against AMP Challenge in the Lung in Mild Steroid-naive Asthmatics.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00445510
• Other study ID #: IPA106620
• Status: Completed
• Phase: Phase 2
• First received: March 7, 2007
• Last updated: May 31, 2012
• Start date: June 2006

Study information

• Verified date: February 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: New Zealand: Health and Disability Ethics Committees
• Study type: Interventional

Clinical Trial Summary

This will be a single centre, randomised, double-blind, placebo-controlled, 2-period crossover study to investigate the effect of treatment with repeat inhaled doses of GSK256066 on bronchial hyper-reactivity to adenosine monophosphate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

Inclusion: (All must Apply)

• Males and females aged 18 to 55 years inclusive.

• 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.

• Documented sensitivity to AMP with a provocative concentration of AMP resulting in a 20% fall in FEV1 (PC20 AMP) of <80 mg/ml at the screening visit.

• Demonstrate stable bronchoconstriction in response to inhaled AMP at the run-in visit. 'Stable bronchoconstriction' is a term to define a population of asthmatics who have a repeatable and reproducible response to a challenge agent that induces bronchoconstriction. The run-in PC20 needs to be within 1.25DD of the screening PC20.

• Non-smoking status as verified by urinary cotinine levels below 300 ng/mL cotinine at the screening visit. This can include ex-smokers who have given up smoking for >6 months and have less than a 5 pack-year smoking history.

• Able and willing to give written informed consent to take part in the study.

• Available to complete all study measurements.

Exclusion:

• Pregnant or nursing females.

• Past or present disease, which as judged by the investigator, may affect the outcome of this study.

• Subject has known history of hypertension or is hypertensive at screening.

• Respiratory tract infection and/or exacerbation of asthma within 4 weeks prior to the first dose of study medication.

• History of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnoea, respiratory arrest and/or hypoxic seizures.

• Unable to abstain from prescription medication, other than short acting inhaled beta-agonists and paracetamol for the treatment of minor ailments eg headache from 48h before the first dose until the follow-up visit.

• The subject has participated in a clinical trial during the previous 3 months.

• 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.

• The subject has tested positive for hepatitis C antibody or hepatitis B surface antigen or HIV antibodies.

• The subject has positive drugs of abuse test.

• Subjects weighing less than 50kg are to be excluded from participating in the study.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• GSK256066

Locations

Country	Name	City	State
New Zealand	GSK Investigational Site	Wellington

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AMP PC20: GSK256066 7 days of 87.5mcg vs placebo 2hrs post-dose on Day 7.
Secondary	AMP PC20: GSK256066 7 days of 87.5mcg vs placebo 24hrs post-dose on Day 7. Exhaled Nitric Oxide: GSK256066 7 days of 87.5mcg vs placebo at Day 1; 1hr and 2hr, Day 7; 1hr, 2hr and 24hr.