Back to resultsDose Response of Fractional Exhaled Nitric Oxide (FeNO) to Inhaled Steroids in Mild-to-moderate Asthma
Primary Purpose
Asthma
Status
Completed
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
Fluticasone Propionate
Fluticasone Propionate
Sponsored by
About this trial
This is an interventional treatment trial for Asthma
Eligibility Criteria
Inclusion Criteria:
- Diagnosis os asthma, taking 200-1000mcg budesonide or equivalent per day
- FENO greater than 30ppb on treatment
Exclusion Criteria:
- Recent RTI or prednisolone
- Smoking within 1 year or 10 pack years
- ABPA, COPD, bronchiectasis
Sites / Locations
- Asthma and Allergy Research Group, University of Dundee
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
High dose ICS
Low dose ICS
Arm Description
Fluticasone Propionate 250mcg bid
Fluticasone propionate 50mcg bid
Outcomes
Primary Outcome Measures
Change in FENO
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00995657
Brief Title
Dose Response of Fractional Exhaled Nitric Oxide (FeNO) to Inhaled Steroids in Mild-to-moderate Asthma
Official Title
Dose Response of FENO to Inhaled Steroids in Mild-to-moderate Asthma
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
October 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Dundee
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Asthma is a chronic disease, which means that it cannot be cured, but the investigators can use inhalers and tablets to control the symptoms. In asthma, the airways become inflamed and irritated which can cause coughing and make the airways tighten. This 'inflammation' is the root of the problem in asthma. Doctors have different ways to measure the inflammation in the airways. One way is to measure a gas called nitric oxide (NO) on the breath. This is made by the lungs when asthmatic inflammation is present. The investigators have been using NO as a test in research labs for many years, but there are still unanswered questions about how it changes between morning and night and how quickly medicines work on it. In most asthmatics, even small doses of inhaled steroids (preventers) can reduce the NO levels to normal, but in some people this does not seem to happen. The investigators now have portable NO machines that are designed for patients to use in the home. The investigators want to follow NO readings in patients with high levels to measure how they respond to different doses of steroid inhalers. The investigators hope this will help the investigators better understand asthma inflammation and treatments.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High dose ICS
Arm Type
Active Comparator
Arm Description
Fluticasone Propionate 250mcg bid
Arm Title
Low dose ICS
Arm Type
Active Comparator
Arm Description
Fluticasone propionate 50mcg bid
Intervention Type
Drug
Intervention Name(s)
Fluticasone Propionate
Intervention Description
Inhaled Fluticasone Propionate 50mcg bid
Intervention Type
Drug
Intervention Name(s)
Fluticasone Propionate
Intervention Description
Inhaled Fluticasone Propionate 250mcg bid
Primary Outcome Measure Information:
Title
Change in FENO
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis os asthma, taking 200-1000mcg budesonide or equivalent per day
FENO greater than 30ppb on treatment
Exclusion Criteria:
Recent RTI or prednisolone
Smoking within 1 year or 10 pack years
ABPA, COPD, bronchiectasis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter A Williamson, MBChB
Organizational Affiliation
University of Dundee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asthma and Allergy Research Group, University of Dundee
City
Dundee
State/Province
Tayside
ZIP/Postal Code
DD1 9SY
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
23364390
Citation
Anderson WJ, Short PM, Williamson PA, Lipworth BJ. Inhaled corticosteroid dose response using domiciliary exhaled nitric oxide in persistent asthma: the FENOtype trial. Chest. 2012 Dec;142(6):1553-1561. doi: 10.1378/chest.12-1310.
Results Reference
result
PubMed Identifier
28065396
Citation
Anderson WJ, Short PM, Jabbal S, Lipworth BJ. Inhaled corticosteroid dose response in asthma: Should we measure inflammation? Ann Allergy Asthma Immunol. 2017 Feb;118(2):179-185. doi: 10.1016/j.anai.2016.11.018. Epub 2017 Jan 3.
Results Reference
derived
Learn more about this trial
Dose Response of Fractional Exhaled Nitric Oxide (FeNO) to Inhaled Steroids in Mild-to-moderate Asthma
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