AsthmaILC2-AsthmaNCT03128762
Circulating Innate Lymphoid Cell Type 2 (ILC2) Levels and Asthma: a Case-control Study
An observational study of Asthma, run by University Hospital, Montpellier.
Trial summary
The primary objective of this study is to demonstrate differences in ILC2 blood levels between asthma patients and control patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Asthma
- What is being tested?
- ILC2 levels in blood
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- 25 Jun 2014to 23 Jun 2015
- 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: This case-control study compares cases (asthma patients) with healthy control subjects. Patients and controls are matched by sex and age (+- 5 years).
Who may be able to join
- The subject has given his/her informed consent and signed the consent form
- The subject is affiliated with or beneficiary of a medical insurance system
- The subject has had asthma for over a year
- The following are present in the patient's medical file: (i) a positive methacholine test (PC20 < 16 mg/ml) OR (ii) reversibility > 200 ml and 12% of the FEV1 after inhaling 400 µg or less of a short acting bronchodilator.
- Treatment with >= 1000 µg inhaled beclometasone equivalents
- The subject has given his/her informed consent and signed the consent form
- The subject is affiliated with or beneficiary of a medical insurance system
Who cannot join
- The subject is pregnant
- The subject is breastfeeding
- The subject is participating in another interventional study
- The subject has participated in another study in the 3 months preceding inclusion
- The subject is in an exclusion period determined by a previous study
- The subject is under judicial protection or is an adult under any kind of guardianship
Show all 24Show fewer
- The subject refuses to sign the consent
- It is impossible to correctly inform the subject
- The subject cannot fluently read French
- Chronic respiratory disease present, known or suspected (other than asthma)
- Treated with Montelukast
- The subject is pregnant
- The subject is breastfeeding
- The subject is participating in another interventional study
- The subject has participated in another study in the 3 months preceding inclusion
- The subject is in an exclusion period determined by a previous study
- The subject is under judicial protection or is an adult under any kind of guardianship
- The subject refuses to sign the consent
- It is impossible to correctly inform the subject
- The subject cannot fluently read French
- Any kind of bronchial problem
- Smokers
- Chronic respiratory disease present, known or suspected
- Treated with Montelukast
About this study
The primary objective of this study is to demonstrate differences in ILC2 blood levels between asthma patients and control patients.
Read the detailed description
The secondary objectives of this study are:
To show that ILC2 levels differ between asthma patients with a "TH2" (helper T cell type 2) profile and asthma patients with a "non-TH2" profile. A TH2 profile is defined as (for a given patient):
- circulating eosinophils > 500 mm^3 at least once during the year AND
- positive allergy skin or specific IgE (Immunoglobulin E) test AND
- induced sputum eosinophil level >3% of leukocytes AND
- exhaled nitric oxide > 25 ppb.
To study the variation in ILC2 levels over time among asthma patients who obtained a good level of control compared to other patients. A good level of control is defined as:
- no exacerbations during 6 months of followup (an exacerbation is defined as the un-planned need for care that modifies the patient's prescription for >48h)
- FEV1 (forced expiratory volume in 1 second) value current / FEV1 best value > 0.8
- symptom levels correspond to an ACQ (Asthma Control Questionnaire) questionnaire score of < 0.75 over the last 7 days
- Conditions
- Asthma
- Being tested
- ILC2 levels in blood
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ILC2 levels in bloodBiological
The levels of circulating ILC2 cells relative to other lymphocytes will be determined via flow cytometry
| Study group | Role | What they receive |
|---|---|---|
| Cases | Patients in this group are asthmatic (see inclusion/exclusion) criteria.
Intervention: ILC2 levels in blood Receives: Biological: ILC2 levels in blood | |
| Controls | Controls are non-asthmatic subjects that are age and gender matched to asthma cases.
Intervention: ILC2 levels in blood Receives: Biological: ILC2 levels in blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
% ILC2 cells among total blood lymphocytes
Determined by flow cytometry
Measured: Day 0
Secondary outcomes (1)
% ILC2 cells among total blood lymphocytes
Determined by flow cytometry; Asthma patients only.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start25 Jun 2014
- Primary completion14 Apr 2015
- Study completion23 Jun 2015
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.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03128762
- Sponsor's protocol ID
- 9243
- Other IDs
- 2013-A01443-42
- Acronym
- ILC2-Asthma
- Status last verified
- Apr 2017
- First submitted
- 20 Apr 2017
- Last updated
- 1 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulating Innate Lymphoid Cell Type 2 (ILC2) Levels and Asthma: a Case-control Study
- ClinicalTrials.gov ID
- NCT03128762
- Acronym / sponsor ID
- ILC2-Asthma / 9243
- Conditions
- Asthma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 25 Jun 2014 (actual)
- Primary completion
- 14 Apr 2015 (actual)
- Study completion
- 23 Jun 2015 (actual)
- First posted
- 25 Apr 2017 (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 primary objective of this study is to demonstrate differences in ILC2 blood levels between asthma patients and control patients.
Detailed description
The secondary objectives of this study are:
To show that ILC2 levels differ between asthma patients with a "TH2" (helper T cell type 2) profile and asthma patients with a "non-TH2" profile. A TH2 profile is defined as (for a given patient):
- circulating eosinophils > 500 mm^3 at least once during the year AND
- positive allergy skin or specific IgE (Immunoglobulin E) test AND
- induced sputum eosinophil level >3% of leukocytes AND
- exhaled nitric oxide > 25 ppb.
To study the variation in ILC2 levels over time among asthma patients who obtained a good level of control compared to other patients. A good level of control is defined as:
- no exacerbations during 6 months of followup (an exacerbation is defined as the un-planned need for care that modifies the patient's prescription for >48h)
- FEV1 (forced expiratory volume in 1 second) value current / FEV1 best value > 0.8
- symptom levels correspond to an ACQ (Asthma Control Questionnaire) questionnaire score of < 0.75 over the last 7 days
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Biological: ILC2 levels in bloodPatients in this group are asthmatic (see inclusion/exclusion) criteria. Intervention: ILC2 levels in blood |
| Controls | – | Biological: ILC2 levels in bloodControls are non-asthmatic subjects that are age and gender matched to asthma cases. Intervention: ILC2 levels in blood |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- This case-control study compares cases (asthma patients) with healthy control subjects. Patients and controls are matched by sex and age (+- 5 years).
Key inclusion criteria (7 listed)
- The subject has given his/her informed consent and signed the consent form
- The subject is affiliated with or beneficiary of a medical insurance system
- The subject has had asthma for over a year
- The following are present in the patient's medical file: (i) a positive methacholine test (PC20 < 16 mg/ml) OR (ii) reversibility > 200 ml and 12% of the FEV1 after inhaling 400 µg or less of a short acting bronchodilator.
- Treatment with >= 1000 µg inhaled beclometasone equivalents
Key exclusion criteria (24 listed)
- The subject is pregnant
- The subject is breastfeeding
- The subject is participating in another interventional study
- The subject has participated in another study in the 3 months preceding inclusion
- The subject is in an exclusion period determined by a previous study
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 |
|---|---|---|
| ILC2 levels in bloodThe levels of circulating ILC2 cells relative to other lymphocytes will be determined via flow cytometry | Biological | Cases, Controls |
Primary outcome
% ILC2 cells among total blood lymphocytes
Time frame: Day 0
Determined by flow cytometry
1 secondary outcome
% ILC2 cells among total blood lymphocytes
Time frame: 6 months
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 1 May 2017.
Related trials for Asthma
Active, not recruitingPhase 3
A Multicentre, Randomised, Double-blind, Parallel Group, Placebo-controlled, Time-to-first Asthma Exacerbation Phase III Efficacy and Safety Study of Benralizumab in Paediatric Patients With Severe Eosinophilic Asthma
Asthma
Not yet recruitingPhase 1
Study of HXN-1013 in Healthy Participants and Participants With Mild-to-Moderate Asthma
Health Adults, Asthma
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingPhase 1
A Phase 1 Trial of AMG 691 in Healthy Chinese and Japanese Volunteers
Healthy Participants
RecruitingPhase 1/2
A Study of HB0056 in Adult Participants With Moderate to Severe Asthma
Asthma
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma, run by University Hospital, Montpellier.
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 7 inclusion and 24 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 1 May 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
% ILC2 cells among total blood lymphocytes (time frame: Day 0). 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 1 May 2017.