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

NCT ID: NCT00995657

Last Updated: 2019-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2011-12-31

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.

Conditions

Asthma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

High dose ICS

Fluticasone Propionate 250mcg bid

Group Type: ACTIVE_COMPARATOR

Fluticasone Propionate

Intervention Type: DRUG

Inhaled Fluticasone Propionate 250mcg bid

Low dose ICS

Fluticasone propionate 50mcg bid

Group Type: ACTIVE_COMPARATOR

Fluticasone Propionate

Intervention Type: DRUG

Inhaled Fluticasone Propionate 50mcg bid

Interventions

Fluticasone Propionate

Inhaled Fluticasone Propionate 50mcg bid

Intervention Type: DRUG

Fluticasone Propionate

Inhaled Fluticasone Propionate 250mcg bid

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Dundee

OTHER

Sponsor Role: lead

Responsible Party

Brian J Lipworth

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Peter A Williamson, MBChB

Role: PRINCIPAL_INVESTIGATOR

University of Dundee

Locations

Asthma and Allergy Research Group, University of Dundee

Dundee, Tayside, United Kingdom

Countries

United Kingdom

References

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.

Reference Type: RESULT

PMID: 23364390 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 28065396 (View on PubMed)

Other Identifiers

PAW003

Identifier Type: -

Identifier Source: org_study_id