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

Asthma Clinical Trial

Official title:

Dose Response of FENO to Inhaled Steroids in Mild-to-moderate Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00995657
• Other study ID #: PAW003
• Status: Completed
• Phase: Phase 4
• Start date: October 2009
• Est. completion date: December 2011

Study information

• Verified date: April 2019
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Fluticasone Propionate
Inhaled Fluticasone Propionate 50mcg bid
• Fluticasone Propionate
Inhaled Fluticasone Propionate 250mcg bid

Locations

Country	Name	City	State
United Kingdom	Asthma and Allergy Research Group, University of Dundee	Dundee	Tayside

Sponsors (1)

Lead Sponsor	Collaborator
University of Dundee

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in FENO		2 weeks