AsthmaPhase 4NCT00995657
Dose Response of Fractional Exhaled Nitric Oxide (FeNO) to Inhaled Steroids in Mild-to-moderate Asthma
A Phase 4 study testing Fluticasone Propionate in people with Asthma, run by University of Dundee at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Fluticasone Propionate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2009to Dec 2011
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis os asthma, taking 200-1000mcg budesonide or equivalent per day
- FENO greater than 30ppb on treatment
Who cannot join
- Recent RTI or prednisolone
- Smoking within 1 year or 10 pack years
- ABPA, COPD, bronchiectasis
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Asthma and Allergy Research Group, University of Dundee
Dundee, Tayside, DD1 9SY
About this study
Official title: Dose Response of FENO to Inhaled Steroids in Mild-to-moderate Asthma
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
- Being tested
- Fluticasone Propionate
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone PropionateDrug
Inhaled Fluticasone Propionate 50mcg bid
Fluticasone PropionateDrug
Inhaled Fluticasone Propionate 250mcg bid
| Study group | Role | What they receive |
|---|---|---|
| High dose ICS | Active comparator | Fluticasone Propionate 250mcg bid Receives: Drug: Fluticasone Propionate |
| Low dose ICS | Active comparator | Fluticasone propionate 50mcg bid Receives: Drug: Fluticasone Propionate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in FENO
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2009 (estimated)
- Study startOct 2009
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Dundee
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian J Lipworth, University of Dundee
- Investigators
- Peter A Williamson, MBChB, Principal investigator, University of Dundee
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00995657
- Sponsor's protocol ID
- PAW003
- Status last verified
- Apr 2019
- First submitted
- 14 Oct 2009
- Last updated
- 12 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23364390Anderson 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.
PubMed 28065396
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Response of FENO to Inhaled Steroids in Mild-to-moderate Asthma
- ClinicalTrials.gov ID
- NCT00995657
- Acronym / sponsor ID
- PAW003
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of DundeeUniversity, hospital or other
- Study start
- Oct 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 15 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High dose ICS | Active comparator | Drug: Fluticasone PropionateFluticasone Propionate 250mcg bid |
| Low dose ICS | Active comparator | Drug: Fluticasone PropionateFluticasone propionate 50mcg bid |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Diagnosis os asthma, taking 200-1000mcg budesonide or equivalent per day
- FENO greater than 30ppb on treatment
Key exclusion criteria (3 listed)
- Recent RTI or prednisolone
- Smoking within 1 year or 10 pack years
- ABPA, COPD, bronchiectasis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone PropionateInhaled Fluticasone Propionate 50mcg bid | Drug | Low dose ICS |
| Fluticasone PropionateInhaled Fluticasone Propionate 250mcg bid | Drug | High dose ICS |
Primary outcome
Change in FENO
Time frame: 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2019.
- Results publication: PubMed 23364390Anderson 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.
- Derived from this study: PubMed 28065396Anderson 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter A Williamson, MBChB principal investigator
University of Dundee
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluticasone Propionate in people with Asthma, run by University of Dundee at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in FENO (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00995657, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2019.