AsthmaCCL18NCT03779152
Regulation of CCL18 by Corticosteroids in Severe Asthma
An observational study of Asthma, run by University Hospital, Lille at 1 site in France.
Trial summary
The majority of asthmatic patients are well controlled by inhaled corticosteroid treatment, however some severe asthma resist this treatment. CCL18 is a target gene for corticosteroids and its dysfunction may correlate with phenotypes of asthma. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Feb 2017
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients consulting for either asthma or chronic rhinitis and meeting the criteria of the control group.
Who may be able to join
- control subjects =
- non-atopic and non-smoking
- cutting to negative pneumoallergens,
- Total IgE levels less than 100 ku / L
- no clinical history of asthma
- without background treatment
Show all 18Show fewer
- patients with intermittent asthma =
- being asymptomatic between asthma attacks,
- with symptoms less than once a week
- having a forced expiratory volume per second (FEV1) of at least 80% of the theoretical.
- treated by ß2 mimetics on demand and will not have inhaled corticosteroids.
- severe asthma insensitive to corticosteroid therapy =
- continuous or nearly continuous treatment with oral corticosteroids (≥ 50% of the year) / or treatment with IC ≥ 1500 microg beclomethasone dipropionate equivalent (BDP)] airway obstruction fixed with FEV1 ranging from less than 15% after 7 days of oral corticosteroid therapy to 40 mg / day of prednisolone;
- Followed at the immunoallergology pneumology consultation for at least 1 year will be recruited.
- Severe corticosensitive asthma = continuous or near continuous treatment with oral corticosteroids (≥ 50% of the year) / or treatment with IC ≥ 1500 microg beclomethasone dipropionate equivalent (BDP)]
- reversibility of FEV1 after treatment with oral corticosteroids.
- Followed at the immunoallergology pneumology consultation for at least 1 year will be recruited.
- controlled moderate asthma treated with inhaled corticosteroids <1500μg equivalent of beclomethasone dipropionate and with: ß2 long-acting mimetics (or anti-leukotriene, or theophylline) for at least 6 months.
Who cannot join
- existence of a chronic inflammatory pathology other than asthma
- active smoking
- pregnant or lactating women
- have received oral corticosteroid treatment in the previous 3 weeks,
- have received non-steroidal anti-inflammatory drugs (NSAIDs) in the previous 2 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
The majority of asthmatic patients are well controlled by inhaled corticosteroid treatment, however some severe asthma resist this treatment. CCL18 is a target gene for corticosteroids and its dysfunction may correlate with phenotypes of asthma.
- Conditions
- Asthma
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| non asthmatic subjects | Not described | |
| intermittent asthmatics | Not described | |
| severe asthmatics sensitive to corticosteroids | Not described | |
| severe asthmatics resistant to corticosteroids | Not described | |
| moderate asthmatics | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between CCL18 rate and asthma phenotypes by elisa test
Measured: Baseline: one session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2018
- Study startFeb 2009
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Benoit Wallaert, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03779152
- Sponsor's protocol ID
- 2008/0813
- Other IDs
- 2008-A00370-55
- Acronym
- CCL18
- Status last verified
- Dec 2018
- First submitted
- 17 Dec 2018
- Last updated
- 21 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of CCL18 by Corticosteroids in Severe Asthma
- ClinicalTrials.gov ID
- NCT03779152
- Acronym / sponsor ID
- CCL18 / 2008/0813
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Feb 2009 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 19 Dec 2018 (actual)
- 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.
The majority of asthmatic patients are well controlled by inhaled corticosteroid treatment, however some severe asthma resist this treatment. CCL18 is a target gene for corticosteroids and its dysfunction may correlate with phenotypes of asthma.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| non asthmatic subjects | – | – |
| intermittent asthmatics | – | – |
| severe asthmatics sensitive to corticosteroids | – | – |
| severe asthmatics resistant to corticosteroids | – | – |
| moderate asthmatics | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients consulting for either asthma or chronic rhinitis and meeting the criteria of the control group.
Key inclusion criteria (18 listed)
- control subjects =
- patients with intermittent asthma =
- severe asthma insensitive to corticosteroid therapy =
- Severe corticosensitive asthma = continuous or near continuous treatment with oral corticosteroids (≥ 50% of the year) / or treatment with IC ≥ 1500 microg beclomethasone dipropionate equivalent (BDP)]
- controlled moderate asthma treated with inhaled corticosteroids <1500μg equivalent of beclomethasone dipropionate and with: ß2 long-acting mimetics (or anti-leukotriene, or theophylline) for at least 6 months.
Key exclusion criteria (5 listed)
- existence of a chronic inflammatory pathology other than asthma
- active smoking
- pregnant or lactating women
- have received oral corticosteroid treatment in the previous 3 weeks,
- have received non-steroidal anti-inflammatory drugs (NSAIDs) in the previous 2 weeks.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation between CCL18 rate and asthma phenotypes by elisa test
Time frame: Baseline: one session
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 21 Dec 2018.
- Individual participant dataSharing planned: No
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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.
Benoit Wallaert, MD, PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by University Hospital, Lille at 1 site in France.
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 18 inclusion and 5 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 21 Dec 2018. 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 France. 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?
Correlation between CCL18 rate and asthma phenotypes by elisa test (time frame: Baseline: one session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Dec 2018.