Predicting Steroid Response Using Exhaled Nitric Oxide (PCR)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Nottingham
ClinicalTrials.gov Identifier:
NCT01308411
First received: May 28, 2010
Last updated: January 31, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Asthma
Other: 50% step down reduction in inhaled corticosteroid dose

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Nottingham:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Enrollment: 191
Study Start Date: November 2010
Study Completion Date: September 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (18-75 years of age)
  • diagnosis of asthma
  • step 2, 3 or 4 on the BTS asthma guidelines.
  • Well controlled asthma and good lung function, as defined as a Juniper asthma control score of < 1.5.
  • Not oral steroids in the last 3 months.

Exclusion Criteria:

  • Incapable of giving informed consent.
  • Poor treatment concordance.
  • Pregnant women.
  • Extensive co-morbidity.
  • Previous admission to ITU with asthma.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01308411

Locations
United Kingdom
Leicester Glenfield Hospital
Leicester, Leicestershire, United Kingdom, LE60DA
Sponsors and Collaborators
University of Nottingham
Investigators
Principal Investigator: Dominick Shaw, Dr University of Nottingham
  More Information

No publications provided

Responsible Party: University of Nottingham
ClinicalTrials.gov Identifier: NCT01308411     History of Changes
Other Study ID Numbers: 10010
Study First Received: May 28, 2010
Last Updated: January 31, 2014
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: National Health Service
United Kingdom: National Institute for Health Research

Keywords provided by University of Nottingham:
Asthma
Inhaled Corticosteroids
Exhaled Nitric oxide
Airways inflammation
Step down
Predicting response

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Nitric Oxide
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Endothelium-Dependent Relaxing Factors
Vasodilator Agents
Cardiovascular Agents
Protective Agents

ClinicalTrials.gov processed this record on April 14, 2014