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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00445510
First received: March 7, 2007
Last updated: May 31, 2012
Last verified: February 2011
  Purpose

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.


Condition Intervention Phase
Asthma
Drug: GSK256066
Phase 2

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

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

Secondary Outcome Measures:
  • 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.

Estimated Enrollment: 24
Study Start Date: June 2006
Intervention Details:
    Drug: GSK256066
    Other Name: GSK256066
  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00445510

Locations
New Zealand
GSK Investigational Site
Wellington, New Zealand, 6035
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00445510     History of Changes
Other Study ID Numbers: IPA106620
Study First Received: March 7, 2007
Last Updated: May 31, 2012
Health Authority: New Zealand: Health and Disability Ethics Committees

Keywords provided by GlaxoSmithKline:
GSK256066,
allergen,
challenge,
repeat dose,
AMP,
mild asthmatics

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014