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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-A01396-35 | Other Identifier | ANSM |
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| Name | Class |
|---|---|
| Centre Hospitalier Universitaire de Nīmes | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal weight | Included patients with a BMI < 25 will be part of this group. |
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| Overweight | Included patients with a BMI >= 25 and <30 will be part of this group. |
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| Obese | Included patients with a BMI >= 30 will be part of this group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| metacholine provocation test and CT-scan low dose | Other | Investigators perform a metacholine provocation test where expiratory CT slices were acquired at each dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in inspiratory:expiratory mean lung density | Baseline versus post-methacholine challenge | 4 hours (after the enrollment) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in lung fractal dimension | Baseline versus post-methacholine challenge | 4 hours (after the enrollment) |
| Bronchial morphometry | Analysis of CT imaging |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Arnaud BOURDIN, MD | University Hospital, Montpellier | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of respiratory disease | Montpellier | 34295 | France |
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| Label | URL |
|---|---|
| SCANN'AIR on the Open Science Framework | View source |
| Derived methods publication. | View source |
| Secondary results publication. |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| Baseline |
| CC10 level | Clara cell 10 kD protein levels in blood | Baseline |
| FeNO | Exhaled nitric oxide level | Baseline |
| FaNO | Alveolar nitric oxide level | Baseline |
| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |