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OpenTrials
Completed

NCT Number: NCT03779152

Regulation of CCL18 by Corticosteroids in Severe Asthma

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Calmette, CHRU

Lille, France

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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
  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Primary outcomes

  1. Correlation between CCL18 rate and asthma phenotypes by elisa test

    Time frame: Baseline: one session

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Acronym: CCL18

Important dates

Study start
2009
Primary completion
2017
Study completion
2017
First posted
Dec 19, 2018
Registry last updated
Dec 21, 2018

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.

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