Predicting Steroid Response Using Exhaled Nitric Oxide (PCR)
Asthma affects 6% of the UK population and costs the NHS 1 billion pounds per year. £473 million alone is spent on inhaled steroid treatment which is designed to reduce inflammation in the breathing tubes.
Unfortunately knowing whether a patient is on just the right amount of steroid treatment is difficult, as asthma is a variable disease and the measures currently used to decide on increasing or decreasing steroid treatment bare little resemblance to the actual amount of inflammation present. Doctors may not reduce treatment as swiftly as necessary if a patient's asthma is well controlled because of concern over asthma attacks; this can result in potential over treatment with inhaled steroids. Although steroid treatment is safe, side effects can occur, and costs are large, so a strategy helping avoid over treatment would be beneficial both to patients and to the NHS.
As the investigators can more accurately measure airway inflammation present in the breathing tubes, using a chemical called nitric oxide present in a patient's breath, the investigators might be able to more accurately predict which patients could safely reduce their steroid treatment. Measuring nitric oxide is simple, and involves breathing into a special machine (similar to a roadside breathalyser). In this study the investigators will measure nitric oxide in patients with well controlled asthma, and reduce their asthma treatment by 50%. The investigators will then follow up the patients and remeasure their nitric oxide. At the end of the study the investigators will see if measurements of nitric oxide predicted which patients could safely step down their treatment. If successful this could help reduce the overall cost to the NHS of inhaled steroids and reduce steroid associated side effects.
|Study Design:||Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
|Official Title:||Using Exhaled Nitric Oxide to Step Down Inhaled Corticosteroid Therapy in Asthma|
- Whether a baseline measurement of airway inflammation, as measured in exhaled breath, or a variation in this measurement over time, can predict which patients can safely step down their asthma treatment without experiencing a loss of asthma control. [ Time Frame: visit 4 and visit 5 ] [ Designated as safety issue: No ]The main outcome is whether a low FENO value at baseline or visit four or visit five, or variability from baseline in FENO, predicts which participants can successfully step down ICS dose without provoking increasing asthma symptom
- The secondary objectives are to establish if this approach is feasible, safe and cost effective, when compared to current clinical guidelines. [ Time Frame: visit 2 and visit 5 ] [ Designated as safety issue: No ]The secondary outcome will be whether a rise in FENO from baseline predicted a clinically important drop in spirometry, methacholine PC20 or change in differential induced sputum cell counts
|Study Start Date:||November 2010|
|Study Completion Date:||September 2013|
|Primary Completion Date:||March 2012 (Final data collection date for primary outcome measure)|
Experimental: 50% reduction in ICS dose
All patients will reduce their inhaled corticosteroid dose by 50%
Other: 50% step down reduction in inhaled corticosteroid dose
All participants will have their inhaled corticosteroid dose reduced by 50%
Show Detailed Description
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308411
|Leicester Glenfield Hospital|
|Leicester, Leicestershire, United Kingdom, LE60DA|
|Principal Investigator:||Dominick Shaw, Dr||University of Nottingham|