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Role of Mitochondria in Non Severe Asthma (MITASTHME)

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ClinicalTrials.gov Identifier: NCT00808730
Recruitment Status : Completed
First Posted : December 16, 2008
Last Update Posted : February 17, 2010
Sponsor:
Information provided by:
University Hospital, Bordeaux

Tracking Information
First Submitted Date  ICMJE December 15, 2008
First Posted Date  ICMJE December 16, 2008
Last Update Posted Date February 17, 2010
Study Start Date  ICMJE February 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 15, 2008)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 15, 2008)
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of Mitochondria in Non Severe Asthma
Official Title  ICMJE Role of Mitochondria in Human Bronchial Smooth Muscle Remodeling in Non Severe Asthma
Brief Summary Asthma is a frequent disease characterized by bronchial hyperresponsiveness, inflammation and remodelling. Bronchial remodelling is an abnormal repair process that contributes to the development of poorly reversible airway narrowing. It can appear very early in the evolution of the disease and involves an increased mass of bronchial smooth muscle (BSM). The mechanism of such an increase has been related with an increase in smooth muscle cell proliferation. Recently, we have demonstrated that, BSM increased proliferation is induced by an enhanced mitochondrial biogenesis in severe asthma (T. Trian et al. J Exp Med 2007). The objective of this study is to investigate the role of smooth muscle cell mitochondria in non severe asthma
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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Condition  ICMJE Asthma
Intervention  ICMJE Procedure: fiberoptic fibroscopy
Bronchial specimens will be obtained by fiberoptic bronchoscopy within 15 days after the enrolment
Study Arms  ICMJE Experimental: 1
fiberoptic fibroscopy
Intervention: Procedure: fiberoptic fibroscopy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 15, 2010)
32
Original Estimated Enrollment  ICMJE
 (submitted: December 15, 2008)
30
Actual Study Completion Date  ICMJE November 2009
Actual Primary Completion Date November 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00808730
Other Study ID Numbers  ICMJE CHUBX 2008/29
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital, Bordeaux
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Pierre-Olivier GIRODET, MCU-PH University Hospital Bordeaux / Département de Pharmacologie, CIC - Université Victor Segalen Bordeaux 2
PRS Account University Hospital, Bordeaux
Verification Date February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP