Circulating Innate Lymphoid Cell Type 2 (ILC2) Levels and Asthma: a Case-control Study (ILC2-Asthma)

April 27, 2017 updated by: University Hospital, Montpellier
The primary objective of this study is to demonstrate differences in ILC2 blood levels between asthma patients and control patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
36

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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).

Description

Inclusion Criteria for Cases:

  • 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

Exclusion Criteria for Cases:

  • 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
  • Chronic respiratory disease present, known or suspected (other than asthma)
  • Treated with Montelukast

Inclusion Criteria for Controls:

  • 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

Exclusion Criteria for Controls:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Cases

Patients in this group are asthmatic (see inclusion/exclusion) criteria.

Intervention: ILC2 levels in blood
Biological: ILC2 levels in blood
The levels of circulating ILC2 cells relative to other lymphocytes will be determined via flow cytometry
Controls

Controls are non-asthmatic subjects that are age and gender matched to asthma cases.

Intervention: ILC2 levels in blood
Biological: ILC2 levels in blood
The levels of circulating ILC2 cells relative to other lymphocytes will be determined via flow cytometry

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
% ILC2 cells among total blood lymphocytes
Time Frame: Day 0
Determined by flow cytometry
Day 0

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
% ILC2 cells among total blood lymphocytes
Time Frame: 6 months
Determined by flow cytometry; Asthma patients only.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 25, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 14, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 23, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 20, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 1, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 27, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 9243
  • 2013-A01443-42 (Other Identifier: RCB number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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