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Completed

NCT Number: NCT03102749

Mechanism and Dynamics of Bronchial Hyper-reactivity to Methacholine in Distal Airway on Obese Patients With Asthma

New insights of small airway contribution to asthma have been gained. Poor levels of control and recurrent exacerbations were shown to have the phenotypic counterpart of asthma with predominant small airway involvement. Very few pathological specificities were identified at this site: mast cells infiltration was suggested as the specific inflammatory change when compared to the proximal airways.Biomarkers in asthma are still complex to validate, especially in the blood, since compartmentalisation is intense in the lung and the airways, a property attributed to the filtering role of the lung to maintain homeostasis. Over the last few years, Fraction exhaled Nitric Oxide (FENO) was developed as a non-invasive and indirect reflection of airway eosinophilic inflammation]. In the blood, peripheral eosinophil counts were shown as a correct T helper 2 (TH2)-phenotype identifier but not perfectly related to airway eosinophilic infiltration. Club cell secretory protein (SCGB1A1) levels have been shown to have some relevance in asthma, chronic obstructive pulmonary disease (COPD), BOS, sarcoidosis, and lung cancer.A biomarker for small airway disease in asthma may improve the management of the disease, identify areas of therapeutic resistance and constitute a therapeutic guidance tool. In this study, investigators aimed to assess small airway involvement in asthmatic women as far as they could. For this purpose, investigators analysed trends in air trapping by acquiring expiratory CT slices at each dose during a bronchoprovocation test with metacholine. Biomarkers were subsequently tested and confronted to clinical and demographical characteristics in their ability to predict the small airway involvement index obtained at CT.

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Key information

About this study

Patients will be recruited in the respiratory department of University Hospital in Montpellier (France) from June 2012 to March 2014. All patients are asthmatics, in order to avoid any gender-related biases, investigators decided to include only women. All participants had normal range spirometry, specifically regarding forced expiratory volume. Each patient will undergo a bronchial provocation test coupled with a thoracic CT scan. Bronchial and alveolar Nitric Oxyde will also be measured, a blood sample will be obtained in order to measure biomarker concentrations, and the patients will be asked to answer the validated Asthma Control Questionnaire in order to quantify asthma control.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female >= 18 yrs
  • Asthma
  • Treated with Inhaled Corticosteroid (ICS)
  • normal range spirometry

Exclusion criteria

  • Patients with other respiratory disease
  • Patients with myocardial infarction (for 3 month before enrollment)
  • Patients with cerebrovascular accident (for 3 month before enrollment)
  • Patients with arterial aneurysm known
  • Patients in pregnancy
  • Patients nursing

Treatment and study plan

metacholine provocation test and CT-scan low dose

Other

Investigators perform a metacholine provocation test where expiratory CT slices were acquired at each dose

Primary outcomes

  1. Change in inspiratory:expiratory mean lung density

    Time frame: 4 hours (after the enrollment)

    Baseline versus post-methacholine challenge

Secondary outcomes

  1. Change in lung fractal dimension

    Time frame: 4 hours (after the enrollment)

    Baseline versus post-methacholine challenge

  2. Bronchial morphometry

    Time frame: Baseline

    Analysis of CT imaging

  3. CC10 level

    Time frame: Baseline

    Clara cell 10 kD protein levels in blood

  4. FeNO

    Time frame: Baseline

    Exhaled nitric oxide level

  5. FaNO

    Time frame: Baseline

    Alveolar nitric oxide level

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Collaborators

  • Centre Hospitalier Universitaire de Nīmes

Registry information

Acronym: SCANN'AIR

Important dates

Study start
2012
Primary completion
2013
Study completion
2014
First posted
Apr 6, 2017
Registry last updated
Jul 5, 2019

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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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