NCT00808730

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Feb 2009

Shorter than P25 for not_applicable asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 16, 2008

Completed
2 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

February 17, 2010

Status Verified

February 1, 2010

Enrollment Period

9 months

First QC Date

December 15, 2008

Last Update Submit

February 15, 2010

Conditions

Keywords

Asthma, airway remodelling, smooth muscle, mitochondria

Outcome Measures

Primary Outcomes (1)

  • 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.

    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).

    One bronchial fiberoptic fibroscopy within 15 days after the enrolment

  • Transcription factors involved in mitochondrial biogenesis assessed by quantitative RT-PCR and western blot.

    One bronchial fiberoptic fibroscopy within 15 days after the enrolment

Study Arms (1)

1

EXPERIMENTAL

fiberoptic fibroscopy

Procedure: fiberoptic fibroscopy

Interventions

Bronchial specimens will be obtained by fiberoptic bronchoscopy within 15 days after the enrolment

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Smoker or former smoker (tobacco or cannabis)
  • Adults protected by law
  • Subjects not affiliated with social security
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Bordeaux, Hôpital Haut-Lévêque

Pessac, 33604, France

Location

Related Publications (2)

  • 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.

    PMID: 18056286BACKGROUND
  • 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.

MeSH Terms

Conditions

AsthmaAirway Remodeling

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Pierre-Olivier GIRODET, MCU-PH

    University Hospital Bordeaux / Département de Pharmacologie, CIC - Université Victor Segalen Bordeaux 2

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 15, 2008

First Posted

December 16, 2008

Study Start

February 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

February 17, 2010

Record last verified: 2010-02

Locations