Skip to main content
OpenTrials
Completed

NCT Number: NCT03128762

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

The primary objective of this study is to demonstrate differences in ILC2 blood levels between asthma patients and control patients.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ILC2 levels in blood

Biological

The levels of circulating ILC2 cells relative to other lymphocytes will be determined via flow cytometry

Primary outcomes

  1. % ILC2 cells among total blood lymphocytes

    Time frame: Day 0

    Determined by flow cytometry

Secondary outcomes

  1. % ILC2 cells among total blood lymphocytes

    Time frame: 6 months

    Determined by flow cytometry; Asthma patients only.

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: ILC2-Asthma

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Apr 25, 2017
Registry last updated
May 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.