Predicting Steroid Response Using Exhaled Nitric Oxide

NCT01308411 | Completed

• 1 other identifier: 10010
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Keywords

Asthma; Inhaled Corticosteroids; Exhaled Nitric oxide; Airways inflammation; Step down; Predicting response

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  visit 4 and visit 5

Secondary Outcomes (1)

• The secondary objectives are to establish if this approach is feasible, safe and cost effective, when compared to current clinical guidelines.

  visit 2 and visit 5

Study Arms (1)

50% reduction in ICS dose

EXPERIMENTAL

All patients will reduce their inhaled corticosteroid dose by 50%

Other: 50% step down reduction in inhaled corticosteroid dose

Interventions

50% step down reduction in inhaled corticosteroid dose OTHER

All participants will have their inhaled corticosteroid dose reduced by 50%

50% reduction in ICS dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Incapable of giving informed consent.
• Poor treatment concordance.
• Pregnant women.
• Extensive co-morbidity.
• Previous admission to ITU with asthma.

Sponsors & Collaborators

• University of Nottingham: lead

Study Sites (1)

Leicester Glenfield Hospital

Leicester, Leicestershire, LE60DA, United Kingdom

Location

Related Publications (1)

• Wilson E, McKeever T, Hargadon B, Hearson G, Anderson J, Hodgson D, Bailey H, Meakin G, Thomas M, Pavord ID, Harrison T, Shaw D. Exhaled nitric oxide and inhaled corticosteroid dose reduction in asthma: a cohort study. Eur Respir J. 2014 Dec;44(6):1705-7. doi: 10.1183/09031936.00093614. Epub 2014 Aug 19. No abstract available.

  PMID: 25142486 DERIVED

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Dominick Shaw, Dr

  University of Nottingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 28, 2010
• First Posted: March 4, 2011
• Study Start: November 1, 2010
• Primary Completion: March 1, 2012
• Study Completion: September 1, 2013
• Last Updated: February 3, 2014

Record last verified: 2014-01

Locations

GB (1)