Status:
COMPLETED
Assessing the Expression and the Activity of Rac1 Protein in the Airway Smooth Muscle of Asthmatic Patient
Lead Sponsor:
Nantes University Hospital
Collaborating Sponsors:
L'institut du thorax - INSERM UMR 1087 / CNRS UMR6291 - IRS-Université de Nantes
IRSR-PL : Institut de Recherche en Santé Respiratoire des Pays de La Loire
Conditions:
Asthma
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
Asthma is a chronic inflammatory respiratory disease affecting 6 to 7% of the French adult population and responsible of 1000 deaths in France every year. Many anti-inflammatory treatments are availab...
Detailed Description
Patients will be openly labeled in one of the following group * 15 patients with severe asthma, without oral corticosteroids treatment., * 6 patients with mild to moderate asthma without treatment, *...
Eligibility Criteria
Inclusion
- Asthmatic Patient :
- Male or Female from 18 to 70 years old,
- Diagnosis of asthma confirmed by
- Existence of one or more following symptoms over 3 months at least (wheezing dyspnea, wheezing, chronic cough and tightness in the chest…)
- AND past pulmonary function test showing a reversible obstructive ventilatory syndrome after inhaled short-acting bronchodilators (improvement of FEV1 above 12% and at least 200 mL FEV1 gain compare to pre-bronchodilatator FEV1)
- AND a removal of the clinically suspected differential diagnoses of asthma (vocal cord dysfunction, Churg-Strauss syndrome etc…). The comorbidities should have been explored and treated or on treatment at enrollment.
- Subject agreed to participate to the study and the biological samples collection,
- Subject is affiliate to a social security system.
- Inclusion criteria for severe asthmatic patient :
- Patient with one of the following criterion will be considered as severe asthmatic patient :
- Patient with a controlled asthma but using high dose of inhaled corticosteroids with another therapeutic classes,
- OR Patient with uncontrolled asthma despite treatment,
- OR Patient with worsening asthma despite treatment.
- -\>Inclusion criteria for non-severe asthmatic patients :
- Moderate Asthmatic patient without standard of care treatment since at least one week before the exploratory visit.
- -\>Controlled sample:
- Non asthmatic cadaveric adults
Exclusion
- Asthmatic Patient :
- Underage,
- Pregnant or breast-feeding women,
- Adult on guardianship
- Active smoker (smoked or Inhaled),
- former smokers (smoked or Inhaled) with a smoking history of ≥10 pack years since less than 5 years.
- Patient with asthma exacerbation the 4 past weeks before the exploratory visit..
- Patient treated by long term oral corticosteroids or ongoing biological therapy or stopped within the 3 months before exploratory visit.
- Patient with severe acute or chronic organ disorder (cardiovascular, respiratory, hepatic, renal, malabsorption)
- Patient with history of unstable angina,
- Patient with platelet count abnormality, or primary or acquired thrombopathy, or an aPTT (activated Partial Thromboplastin Time) greater than or equal to 1,5 times normal or patient with a Quick Time \> 26 seconds
- Patient under a systemic immunomodulatory or immunosuppressive treatment
- Patient with anticoagulants or anti-platelet aggregating drugs other than D-lysin acetylsalicylate and that could not be suspended before the bronchial fibroscopy.
- Patient with hypersensitivity to the treatment used during the bronchial fibroscopy: Hydroxyzine, Midazolam, Xylocaine.
- Patient with AME (Government Medical Assistance),
- Patient having physical and psychological disabilities to follow the protocol,
- Patient included in another interventional research protocol,
- Patient having risk factors of Creutzfeld-Jakob disease
- Controlled sample:
- Asthmatic patient
Key Trial Info
Start Date :
March 5 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2023
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT03325088
Start Date
March 5 2019
End Date
November 17 2023
Last Update
April 12 2024
Active Locations (1)
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1
University Hospital
Nantes, France