- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00808730
Role of Mitochondria in Non Severe Asthma (MITASTHME)
Role of Mitochondria in Human Bronchial Smooth Muscle Remodeling in Non Severe Asthma
Study Overview
Detailed Description
Bronchial remodelling mainly involves an increased mass of bronchial smooth muscle (BSM), which is related with an increase proliferation of BSM cells. Recently, using BSM cells obtained from severe asthmatics, we have demonstrated that such an increase proliferation was induced by an activation cascade involving an abnormal calcium entry, and the subsequent activation of Calmodulin-kinase IV, PGC-1alpha, NRF-1 and mt-TFA leading to an increase mitochondrial biogenesis (T. Trian et al, J Exp Med 2007). The objective of this study is to investigate the role of BSM cell mitochondria in non severe asthma.
For this purpose, 30 non severe asthmatic adult patients (>18 yr) will be prospectively recruited from the "CHU de Bordeaux" according to the Global Initiative for Asthma (GINA) guidelines. Inclusion visit will include written informed consent, asthma control questionnaire, clinical examination, lung function testing (i.e. arterial gas, exhaled NO, plethysmography), prick tests, chest X Ray and blood sample for total IgE levels. Bronchial specimens will be obtained from all subjects by fiberoptic bronchoscopy. BSM remodelling will be evaluated by morphological analysis. Patients will be divided into 2 groups according to the presence or the absence of BSM remodelling. Using BSM cell culture, the role of mitochondria will be analyzed by electronic microscopy, confocal microscopy, immunoblotting, RT-PCR and oxygraphy.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Pessac, France, 33604
- University Hospital Bordeaux, Hôpital Haut-Lévêque
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female aged more than 18 years
- Diagnosis of intermittent asthma, mild persistent asthma or moderate persistent according to ATS criteria
- Forced expiratory volume in one second > 60% predicted
- Written informed consent
Exclusion Criteria:
- Smoker or former smoker (tobacco or cannabis)
- Adults protected by law
- Subjects not affiliated with social security
- Subjects during exclusion relative to another protocol or for which the annual maximum allowance of 3800 euros has been reached
- Subject with any co-morbidity (except chronic rhinitis, chronic sinusitis nasal polyps or gastro-oesophageal reflux)
- Asthma exacerbation within 6 weeks before enrolment
- Infections of the upper airway within 3 months before enrolment
- Chronic viral infections (hepatitis, HIV)
- Pregnancy or breastfeeding
- Contraindications to bronchoscopy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1
fiberoptic fibroscopy
|
Bronchial specimens will be obtained by fiberoptic bronchoscopy within 15 days after the enrolment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
BSM mitochondrial biogenesis assessed by the number of mitochondrial sections using electron microscopy, the porin content using western blot, and mitochondrial oxygen consumption evaluated by oxygraphy.
Time Frame: One bronchial fiberoptic fibroscopy within 15 days after the enrolment
|
One bronchial fiberoptic fibroscopy within 15 days after the enrolment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
BSM remodelling assessed by optic microscopy and immunohistochemistry (using anti-alpha smooth muscle actin antibody).
Time Frame: One bronchial fiberoptic fibroscopy within 15 days after the enrolment
|
One bronchial fiberoptic fibroscopy within 15 days after the enrolment
|
Transcription factors involved in mitochondrial biogenesis assessed by quantitative RT-PCR and western blot.
Time Frame: One bronchial fiberoptic fibroscopy within 15 days after the enrolment
|
One bronchial fiberoptic fibroscopy within 15 days after the enrolment
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Pierre-Olivier GIRODET, MCU-PH, University Hospital Bordeaux / Département de Pharmacologie, CIC - Université Victor Segalen Bordeaux 2
Publications and helpful links
General Publications
- Trian T, Benard G, Begueret H, Rossignol R, Girodet PO, Ghosh D, Ousova O, Vernejoux JM, Marthan R, Tunon-de-Lara JM, Berger P. Bronchial smooth muscle remodeling involves calcium-dependent enhanced mitochondrial biogenesis in asthma. J Exp Med. 2007 Dec 24;204(13):3173-81. doi: 10.1084/jem.20070956. Epub 2007 Dec 3.
- Girodet PO, Allard B, Thumerel M, Begueret H, Dupin I, Ousova O, Lassalle R, Maurat E, Ozier A, Trian T, Marthan R, Berger P. Bronchial Smooth Muscle Remodeling in Nonsevere Asthma. Am J Respir Crit Care Med. 2016 Mar 15;193(6):627-33. doi: 10.1164/rccm.201507-1404OC.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHUBX 2008/29
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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