AsthmaNCT00411320
Determinants of Corticosteroid Insensitivity in Smokers With Asthma
A study testing oral steroid-dexamethasone in people with Asthma and Smoking, run by University of Glasgow at 1 site in United Kingdom.
Trial summary
Smokers with asthma display a relative insensitivity to inhaled and oral corticosteroids. The causes of this phenomenon are currently unknown. The investigators will perform a number of blood \& breathing tests to try to discover the cause/s behind this phenomenon with the aim of producing leads for further… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Asthma, Smoking, Steroid Resistance
- What is being tested?
- oral steroid-dexamethasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2007to Sep 2010
- Phase
- Interventional
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Asthma (defined by either reversibility to bronchodilator or methacholine testing)
- Asthma duration of 6 months or greater
- Stable asthma
- Age 18-60
- Treatment with inhaled corticosteroids
- Smoking history consistent with group
Show all 9Show fewer
- smokers with asthma: > or = 5 pack years and currently smoking more than 5 cigarettes per day
- ex-smokers: smoking ceased > or = two years prior to recruitment, minimum 5 pack year history
- non-smokers: no smoking history
Who cannot join
- Presence of medical condition likely to be exacerbated by treatment with oral corticosteroids
- Treatment with > 2000 mcg beclomethasone (or equivalent) per day
- Subject requires oral corticosteroids to maintain asthma control
- Subject requires oral theophylline to maintain asthma control
- Recent treatment with oral corticosteroids
- Pregnancy or subject planning to become pregnant
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Asthma Research Unit, Glasgow University
Glasgow, Scotland, G12 0YN
About this study
Smokers with asthma display a relative insensitivity to inhaled and oral corticosteroids. The causes of this phenomenon are currently unknown. The investigators will perform a number of blood \& breathing tests to try to discover the cause/s behind this phenomenon with the aim of producing leads for further investigation and possible new treatments for smokers with asthma.
Read the detailed description
Smokers with asthma display a relative insensitivity to inhaled and oral corticosteroids. The causes of this phenomenon are currently unknown. However research into steroid resistance in severe asthma and the smoking related condition chronic obstructive pulmonary disease (COPD) points to a number of possible causes. We will characterise a group of smokers with asthma and perform a number of investigations and compare the results to ex-smokers and never smokers with asthma with the aim of establishing which previously published steroid resistance phenomena are related to the steroid resistance displayed by smokers with asthma. Results produced from this trial will provide hypothesis generating information leading to future pharmaceutical trials.
- Conditions
- Asthma, Smoking, Steroid Resistance, Corticosteroid Insensitivity
- Being tested
- oral steroid-dexamethasone
- Keywords
- Asthma, Smoking, Steroid Resistance, Corticosteroid insensitivity
- Medical subject headings
- Asthma, Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral steroid-dexamethasoneDrug
2 week steroid trial
| Study group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Smokers with asthma Receives: Drug: oral steroid-dexamethasone |
| Group 2 | Active comparator | Ex-smokers with asthma Receives: Drug: oral steroid-dexamethasone |
| Group 3 | Active comparator | Non-smokers with asthma Receives: Drug: oral steroid-dexamethasone |
| Group 4 | No intervention | Non smokers without asthma |
| Group 5 | No intervention | Smokers without asthma or COPD |
What is being measured
The primary outcome is the main question the study is designed to answer.
bronchodilator response to oral corticosteroid trial in smokers with asthma vs non smokers and ex-smokers with asthma
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 posted14 Dec 2006 (estimated)
- Study startJan 2007
- Primary completionAug 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Glasgow
- Sponsor type
- University, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government
- Investigators
- Mark Spears, MRCP, Principal investigator, University of GlasgowNeil C Thomson, FRCP, Principal investigator, University of GlasgowRekha Chaudhuri, MD, Principal investigator, University of Glasgow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00411320
- Sponsor's protocol ID
- AR002
- Status last verified
- Sep 2008
- First submitted
- 12 Dec 2006
- Last updated
- 4 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Spears M, McSharry C, Donnelly I, Jolly L, Brannigan M, Thomson J, Lafferty J, Chaudhuri R, Shepherd M, Cameron E, Thomson NC. Peripheral blood dendritic cell subtypes are significantly elevated in subjects with asthma. Clin Exp Allergy. 2011 May;41(5):665-72. doi: 10.1111/j.1365-2222.2010.03692.x. Epub 2011 Feb 21.
PubMed 21338429
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determinants of Corticosteroid Insensitivity in Smokers With Asthma
- ClinicalTrials.gov ID
- NCT00411320
- Acronym / sponsor ID
- AR002
- Conditions
- Asthma, Smoking, Steroid Resistance, Corticosteroid Insensitivity
- Keywords
- Asthma, Smoking, Steroid Resistance, Corticosteroid insensitivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of GlasgowUniversity, hospital or other
- Collaborators
- Chief Scientist Office of the Scottish Government
- Study start
- Jan 2007
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 14 Dec 2006 (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.
Smokers with asthma display a relative insensitivity to inhaled and oral corticosteroids. The causes of this phenomenon are currently unknown. The investigators will perform a number of blood \& breathing tests to try to discover the cause/s behind this phenomenon with the aim of producing leads for further investigation and possible new treatments for smokers with asthma.
Detailed description
Smokers with asthma display a relative insensitivity to inhaled and oral corticosteroids. The causes of this phenomenon are currently unknown. However research into steroid resistance in severe asthma and the smoking related condition chronic obstructive pulmonary disease (COPD) points to a number of possible causes. We will characterise a group of smokers with asthma and perform a number of investigations and compare the results to ex-smokers and never smokers with asthma with the aim of establishing which previously published steroid resistance phenomena are related to the steroid resistance displayed by smokers with asthma. Results produced from this trial will provide hypothesis generating information leading to future pharmaceutical trials.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Drug: oral steroid-dexamethasoneSmokers with asthma |
| Group 2 | Active comparator | Drug: oral steroid-dexamethasoneEx-smokers with asthma |
| Group 3 | Active comparator | Drug: oral steroid-dexamethasoneNon-smokers with asthma |
| Group 4 | No intervention | –Non smokers without asthma |
| Group 5 | No intervention | –Smokers without asthma or COPD |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Asthma (defined by either reversibility to bronchodilator or methacholine testing)
- Asthma duration of 6 months or greater
- Stable asthma
- Age 18-60
- Treatment with inhaled corticosteroids
Key exclusion criteria (6 listed)
- Presence of medical condition likely to be exacerbated by treatment with oral corticosteroids
- Treatment with > 2000 mcg beclomethasone (or equivalent) per day
- Subject requires oral corticosteroids to maintain asthma control
- Subject requires oral theophylline to maintain asthma control
- Recent treatment with oral corticosteroids
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 |
|---|---|---|
| oral steroid-dexamethasone2 week steroid trial | Drug | Group 1, Group 2, Group 3 |
Primary outcome
bronchodilator response to oral corticosteroid trial in smokers with asthma vs non smokers and ex-smokers with asthma
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 4 Aug 2011.
- Derived from this study: PubMed 21338429Spears M, McSharry C, Donnelly I, Jolly L, Brannigan M, Thomson J, Lafferty J, Chaudhuri R, Shepherd M, Cameron E, Thomson NC. Peripheral blood dendritic cell subtypes are significantly elevated in subjects with asthma. Clin Exp Allergy. 2011 May;41(5):665-72. doi: 10.1111/j.1365-2222.2010.03692.x. Epub 2011 Feb 21.
- unit websiteLink provided by the sponsor.
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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.
Mark Spears, MRCP principal investigator
University of Glasgow
Neil C Thomson, FRCP principal investigator
University of Glasgow
Rekha Chaudhuri, MD principal investigator
University of Glasgow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oral steroid-dexamethasone in people with Asthma and Smoking, run by University of Glasgow 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 9 inclusion and 6 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 4 Aug 2011. 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.
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?
bronchodilator response to oral corticosteroid trial in smokers with asthma vs non smokers and ex-smokers with asthma (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 NCT00411320, which also lists 1 linked publication.
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 4 Aug 2011.