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

NCT03102749 | Completed

• 2 other identifiers: 88362011-A01396-35
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Keywords

Airways; asthma; overweight

Outcome Measures

Primary Outcomes (1)

• Change in inspiratory:expiratory mean lung density

  Baseline versus post-methacholine challenge

  4 hours (after the enrollment)

Secondary Outcomes (5)

• Change in lung fractal dimension

  4 hours (after the enrollment)

• Bronchial morphometry

  Baseline

• CC10 level

  Baseline

• FeNO

  Baseline

• FaNO

  Baseline

Study Arms (3)

Normal weight

Included patients with a BMI \< 25 will be part of this group.

Other: metacholine provocation test and CT-scan low 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

Obese

Included patients with a BMI \>= 30 will be part of this group.

Other: metacholine provocation test and CT-scan low dose

Interventions

metacholine provocation test and CT-scan low dose OTHER

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

Normal weight; Obese; Overweight

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Montpellier: lead
• Centre Hospitalier Universitaire de Nīmes: collaborator

Study Sites (1)

Department of respiratory disease

Montpellier, 34295, France

Location

Related Links

• SCANN'AIR on the Open Science Framework
• Derived methods publication.
• Secondary results publication.

MeSH Terms

Conditions

Asthma; Overweight

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Arnaud BOURDIN, MD

  University Hospital, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2015
• First Posted: April 6, 2017
• Study Start: June 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: December 1, 2014
• Last Updated: July 5, 2019

Record last verified: 2019-07

Locations

FR (1)