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

Asthma Clinical Trial

— SCANN'AIR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03102749
• Other study ID #: 8836
• Secondary ID: 2011-A01396-35
• Status: Completed
• Start date: June 2012
• Est. completion date: December 2014

Study information

• Verified date: July 2019
• Source: University Hospital, Montpellier
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: December 2014
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Bronchial Hyperreactivity

Intervention

Other:
• metacholine provocation test and CT-scan low dose
Investigators perform a metacholine provocation test where expiratory CT slices were acquired at each dose

Locations

Country	Name	City	State
France	Department of respiratory disease	Montpellier

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Montpellier	Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in inspiratory:expiratory mean lung density	Baseline versus post-methacholine challenge	4 hours (after the enrollment)
Secondary	Change in lung fractal dimension	Baseline versus post-methacholine challenge	4 hours (after the enrollment)
Secondary	Bronchial morphometry	Analysis of CT imaging	Baseline
Secondary	CC10 level	Clara cell 10 kD protein levels in blood	Baseline
Secondary	FeNO	Exhaled nitric oxide level	Baseline
Secondary	FaNO	Alveolar nitric oxide level	Baseline

External Links

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