AsthmaMITASTHMENCT00808730
Role of Mitochondria in Non Severe Asthma
A study testing fiberoptic fibroscopy in people with Asthma, run by University Hospital, Bordeaux at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- fiberoptic fibroscopy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2009to Nov 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- Infections of the upper airway within 3 months before enrolment
- Chronic viral infections (hepatitis, HIV)
- Pregnancy or breastfeeding
- Contraindications to bronchoscopy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Role of Mitochondria in Human Bronchial Smooth Muscle Remodeling in Non Severe Asthma
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
Read the 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.
- Conditions
- Asthma
- Being tested
- fiberoptic fibroscopy
- Keywords
- Asthma, airway remodelling, smooth muscle, mitochondria
- Medical subject headings
- Asthma, Airway Remodeling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fiberoptic fibroscopyProcedure or surgery
Bronchial specimens will be obtained by fiberoptic bronchoscopy within 15 days after the enrolment
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | fiberoptic fibroscopy Receives: Procedure: fiberoptic fibroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: One bronchial fiberoptic fibroscopy within 15 days after the enrolment
Secondary outcomes (2)
BSM remodelling assessed by optic microscopy and immunohistochemistry (using anti-alpha smooth muscle actin antibody).
Measured: One bronchial fiberoptic fibroscopy within 15 days after the enrolment
Transcription factors involved in mitochondrial biogenesis assessed by quantitative RT-PCR and western blot.
Measured: One bronchial fiberoptic fibroscopy within 15 days after the enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2008 (estimated)
- Study startFeb 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Investigators
- Pierre-Olivier GIRODET, MCU-PH, Principal investigator, University Hospital Bordeaux / Département de Pharmacologie, CIC - Université Victor Segalen Bordeaux 2
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00808730
- Sponsor's protocol ID
- CHUBX 2008/29
- Acronym
- MITASTHME
- Status last verified
- Feb 2010
- First submitted
- 15 Dec 2008
- Last updated
- 17 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 18056286Girodet 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.
PubMed 26540234
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Mitochondria in Human Bronchial Smooth Muscle Remodeling in Non Severe Asthma
- ClinicalTrials.gov ID
- NCT00808730
- Acronym / sponsor ID
- MITASTHME / CHUBX 2008/29
- Conditions
- Asthma
- Keywords
- Asthma, airway remodelling, smooth muscle, mitochondria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 16 Dec 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: fiberoptic fibroscopyfiberoptic fibroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (10 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fiberoptic fibroscopyBronchial specimens will be obtained by fiberoptic bronchoscopy within 15 days after the enrolment | Procedure or surgery | 1 |
Primary outcome
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
2 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2010.
- Background: PubMed 18056286Trian 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.
- Derived from this study: PubMed 26540234Girodet 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.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pierre-Olivier GIRODET, MCU-PH principal investigator
University Hospital Bordeaux / Département de Pharmacologie, CIC - Université Victor Segalen Bordeaux 2
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fiberoptic fibroscopy in people with Asthma, run by University Hospital, Bordeaux at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00808730, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2010.