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

NCT00445510 | Completed Phase 2

• 1 other identifier: IPA106620
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Keywords

GSK256066,; allergen,; challenge,; repeat dose,; AMP,; mild asthmatics

Outcome Measures

Primary Outcomes (1)

• AMP PC20: GSK256066 7 days of 87.5mcg vs placebo 2hrs post-dose on Day 7.

Secondary Outcomes (1)

• 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.

Interventions

GSK256066 DRUG

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Wellington, 6035, New Zealand

Location

MeSH Terms

Conditions

Asthma

Interventions

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

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune 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: March 7, 2007
• First Posted: March 9, 2007
• Study Start: June 1, 2006
• Last Updated: June 4, 2012

Record last verified: 2011-02

Locations

NZ (1)