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

NCT00995657 | Completed Phase 4

• 1 other identifier: PAW003
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Change in FENO

  2 weeks

Study Arms (2)

High dose ICS

ACTIVE COMPARATOR

Fluticasone Propionate 250mcg bid

Drug: Fluticasone Propionate

Low dose ICS

ACTIVE COMPARATOR

Fluticasone propionate 50mcg bid

Drug: Fluticasone Propionate

Interventions

Fluticasone Propionate DRUG

Inhaled Fluticasone Propionate 50mcg bid

Low dose ICS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis os asthma, taking 200-1000mcg budesonide or equivalent per day
• FENO greater than 30ppb on treatment

You may not qualify if:

• Recent RTI or prednisolone
• Smoking within 1 year or 10 pack years
• ABPA, COPD, bronchiectasis

Sponsors & Collaborators

• University of Dundee: lead

Study Sites (1)

Asthma and Allergy Research Group, University of Dundee

Dundee, Tayside, DD1 9SY, United Kingdom

Location

Related Publications (2)

• 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.

  PMID: 23364390 RESULT

• 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.

  PMID: 28065396 DERIVED

MeSH Terms

Conditions

Asthma

Interventions

Fluticasone

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• Peter A Williamson, MBChB

  University of Dundee

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 14, 2009
• First Posted: October 15, 2009
• Study Start: October 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: April 12, 2019

Record last verified: 2019-04

Locations

GB (1)