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Mechanism and Dynamics of Bronchial Hyper-reactivity to Methacholine in Distal Airway on Obese Patients With Asthma (SCANN'AIR)

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ClinicalTrials.gov Identifier: NCT03102749
Recruitment Status : Completed
First Posted : April 6, 2017
Last Update Posted : November 27, 2017
Sponsor:
Collaborator:
Centre Hospitalier Universitaire de Nīmes
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
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.

Condition or disease Intervention/treatment
Asthma Other: metacholine provocation test and CT-scan low dose

Detailed Description:
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.

Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Official Title: Mechanism and Dynamics of Bronchial Hyper-reactivity to Methacholine in Distal Airway on Obese Patients With Asthma
Study Start Date : June 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Group/Cohort Intervention/treatment
Normal weight
Included patients with a BMI < 25 will be part of this group.
Other: metacholine provocation test and CT-scan low dose
Investigators perform a metacholine provocation test where expiratory CT slices were acquired at each dose

Overweight
Included patients with a BMI >= 25 and <30 will be part of this group.
Other: metacholine provocation test and CT-scan low dose
Investigators perform a metacholine provocation test where expiratory CT slices were acquired at each dose

Obese
Included patients with a BMI >= 30 will be part of this group.
Other: metacholine provocation test and CT-scan low dose
Investigators perform a metacholine provocation test where expiratory CT slices were acquired at each dose




Primary Outcome Measures :
  1. Change in inspiratory:expiratory mean lung density [ Time Frame: 4 hours (after the enrollment) ]
    Baseline versus post-methacholine challenge


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03102749


Locations
France
Department of respiratory disease
Montpellier, France, 34295
Sponsors and Collaborators
University Hospital, Montpellier
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Arnaud BOURDIN, MD University Hospital, Montpellier

Additional Information:
Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT03102749     History of Changes
Other Study ID Numbers: 8836
2011-A01396-35 ( Other Identifier: ANSM )
First Posted: April 6, 2017    Key Record Dates
Last Update Posted: November 27, 2017
Last Verified: March 2017

Keywords provided by University Hospital, Montpellier:
Airways
asthma
overweight

Additional relevant MeSH terms:
Asthma
Bronchial Hyperreactivity
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Methacholine Chloride
Miotics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Parasympathomimetics
Bronchoconstrictor Agents
Respiratory System Agents
Muscarinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action