Dose Response of Fractional Exhaled Nitric Oxide (FeNO) to Inhaled Steroids in Mild-to-moderate Asthma
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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 Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Dose Response of FENO to Inhaled Steroids in Mild-to-moderate Asthma |
- Change in FENO [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]
| 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| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| 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| United Kingdom | |
| Asthma and Allergy Research Group, University of Dundee | |
| Dundee, Tayside, United Kingdom, DD1 9SY | |
| Principal Investigator: | Peter A Williamson, MBChB | University of Dundee |
More Information
Additional Information:
No publications provided by University of Dundee
Additional 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 |
| Study First Received: | October 14, 2009 |
| Last Updated: | June 11, 2012 |
| Health Authority: | United Kingdom: Medicines and Healthcare Products Regulatory Agency United Kingdom: Research Ethics Committee |
Additional relevant MeSH terms:
|
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Fluticasone Bronchodilator Agents |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Anti-Asthmatic Agents Respiratory System Agents Therapeutic Uses Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 18, 2013