Dose Response of Fractional Exhaled Nitric Oxide (FeNO) to Inhaled Steroids in Mild-to-moderate Asthma

Phase 4

Completed

• Conditions: Asthma
• Interventions: Drug: Fluticasone Propionate

• Registration Number: NCT00995657
• Lead Sponsor: University of Dundee

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2009-10-14
• Study First Submitted QC: 2009-10-14
• Study First Posted: 2009-10-15
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2019-04
• Last Update Submitted: 2019-04-10
• Last Update Posted: 2019-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High dose ICS	Fluticasone Propionate	Fluticasone Propionate 250mcg bid
Low dose ICS	Fluticasone Propionate	Fluticasone propionate 50mcg bid

Primary Outcome Measures

Name	Time	Method
Change in FENO	2 weeks

Trial Locations

Locations (1)

Asthma and Allergy Research Group, University of Dundee; 🇬🇧 Dundee, Tayside, United Kingdom