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

• Sponsor: University of Dundee (Other)
• Overall Status: Completed
• CT.gov ID: NCT00995657
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arms: 2
• Duration (Months): 26
• Patients Per Site Per Month: 0.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Fluticasone Propionate; Drug: Fluticasone Propionate	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Dose Response of FENO to Inhaled Steroids in Mild-to-moderate Asthma
• Study Start Date: Oct 1, 2009
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Dec 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: High dose ICS Fluticasone Propionate 250mcg bid	Drug: Fluticasone Propionate; Inhaled Fluticasone Propionate 250mcg bid
Active Comparator: Low dose ICS Fluticasone propionate 50mcg bid	Drug: Fluticasone Propionate; Inhaled Fluticasone Propionate 50mcg bid

Outcome Measures

Primary Outcome Measures

1. Change in FENO [2 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Asthma and Allergy Research Group, University of Dundee	Dundee	Tayside	United Kingdom	DD1 9SY

Sponsors and Collaborators

• University of Dundee

Investigators

• Principal Investigator: Peter A Williamson, MBChB, University of Dundee

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Brian J Lipworth, Professor, University of Dundee
• ClinicalTrials.gov Identifier: NCT00995657
• Other Study ID Numbers: PAW003
• First Posted: Oct 15, 2009
• Last Update Posted: Apr 12, 2019
• Last Verified: Apr 1, 2019

• Additional relevant MeSH terms: Asthma; Fluticasone; Xhance

Study Results

No Results Posted as of Apr 12, 2019