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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00995657
First Posted: October 15, 2009
Last Update Posted: June 12, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Brian J Lipworth, University of Dundee
  Purpose
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 Intervention Phase
Asthma Drug: Fluticasone Propionate Phase 4

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Brian J Lipworth, University of Dundee:

Primary Outcome Measures:
  • Change in FENO [ Time Frame: 2 weeks ]

Enrollment: 21
Study Start Date: October 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00995657


Locations
United Kingdom
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
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Brian J Lipworth, Professor, University of Dundee
ClinicalTrials.gov Identifier: NCT00995657     History of Changes
Other Study ID Numbers: PAW003
First Submitted: October 14, 2009
First Posted: October 15, 2009
Last Update Posted: June 12, 2012
Last Verified: June 2012

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents