ASTHMAAVADNCT02593279
AVAD: Asthma With Small Airways Dysfunction
A study testing asthma with proximal airways obstruction phenotype profile description with clinical, biological, morphologic and genetic elements. and asthma with small airways dysfunction phenotype profile description with clinical, biological, morphologic and genetic elements. in people with ASTHMA, run by Hospices Civils de Lyon at 4 sites in France.
Trial summary
The aim of the study is to describe asthma phenotype with small airways dysfunction, in a multiparametric manner, with clinical, biological, morphological and genetic elements compared with asthma with proximal airways obstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ASTHMA
- What is being tested?
- asthma with proximal airways obstruction phenotype profile description with clinical, biological, morphologic and genetic elements. and asthma with small airways dysfunction phenotype profile description with clinical, biological, morphologic and genetic elements.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 4 sitesFrance
- Study dates
- Feb 2016to Jul 2017
- 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
General Inclusion Criteria:
- man or woman
- age ≥ 18 years
- asthma
- inform consent signed
- affiliated to health insurance
Specific inclusion criteria : asthma with proximal airways obstruction GROUP
- Maximal Voluntary Ventilation (MMV)<80%
- MMV / Forced Vital Capacity (FVC)≤70%
- Carbon Monoxide Transfer Coefficient (KcO)>80%
Specific inclusion criteria : asthma with small airways dysfunction GROUP
- Maximal Voluntary Ventilation (MMV)≥80%
- MMV / Vital Capacity(VC)>70%
- Carbon Monoxide Transfer Coefficient (KcO)>80%
General Exclusion Criteria:
- pregnant woman or breastfeeding
- patient participating to other biomedical research
- patient who have participated to other biomedical research within the past 3 months
- patient refusing to sign the inform consent
Specific exclusion criteria :
- Patient who stopped smoking since less than 12 months
- Pathological state related to obstructive distal airway damage
- Broncho-pulmonary infectious disease within the past 4 weeks
- Solid tumor curated by chemotherapy or chest radiotherapy
- Chronic respiratory disease
- Asthma exacerbation within the past 3 months
- Oral or systemic corticotherapy within the past 3 months
Trial locations and contacts
4 sites in 1 country.
France4 sites
Cabinets de Pneumologie Liberale
Caluire-et-Cuire
Hospices Civils de Lyon
Lyon, 69002
CABINETS DE PNEUMOLOGIE LIBERALE HIA Desgenettes
Lyon
HC pneumo C
Pierre-Bénite
About this study
Official title: AVAD: Asthma With Small Airways Dysfunction. Clinical, Immunobiological, Tomodensitometric Description, Genetic Signature Compared With Asthmatic Population With Proximal Airways Obstruction
The aim of the study is to describe asthma phenotype with small airways dysfunction, in a multiparametric manner, with clinical, biological, morphological and genetic elements compared with asthma with proximal airways obstruction.
The objective of this study is also to complete the clinical, immunobiological and morphological analysis of asthma with small airways dysfunction.
- Conditions
- ASTHMA
- Being tested
- asthma with proximal airways obstruction phenotype profile description with clinical, biological, morphologic and genetic elements., asthma with small airways dysfunction phenotype profile description with clinical, biological, morphologic and genetic elements.
- Keywords
- Asthma, phenotype, small, airway, proximal, dysfunction
- Medical subject headings
- Asthma, Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
asthma with proximal airways obstruction phenotype profile description with clinical, biological, morphologic and genetic elements.Genetic
symptoms, medical history, date of start, date of aggravation, comorbidities, increased factors related to asthma, blood eosinophils, blood periostin, allergologic patch test, igE analysis, tomodensitometric test.
asthma with small airways dysfunction phenotype profile description with clinical, biological, morphologic and genetic elements.Genetic
symptoms, medical history, date of start, date of aggravation, comorbidities, increased factors related to asthma, blood eosinophils, blood periostin, allergologic patch test, IgE analysis, tomodensitometric test.
| Study group | Role | What they receive |
|---|---|---|
| asthma with proximal or diffuse lung damage | Active comparator | Not described Receives: Genetic: asthma with proximal airways obstruction phenotype profile description with clinical, biological, morphologic and genetic elements. |
| asthma with small airway prevailing damage | Experimental | Not described Receives: Genetic: asthma with small airways dysfunction phenotype profile description with clinical, biological, morphologic and genetic elements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
mRNA expression levels.
mRNA expression levels will be measured by microarray analysis.
Measured: maximum 4 weeks after the inclusion visit.
Secondary outcomes (11)
clinical asthma profile : symptoms
symptoms
Measured: maximum 4 weeks after the inclusion visit.
clinical asthma profile : medical history
medical history
Measured: maximum 4 weeks after the inclusion visit.
clinical asthma profile : date of start
date of start
Measured: maximum 4 weeks after the inclusion visit.
clinical asthma profile : date of aggravation
date of aggravation
Measured: maximum 4 weeks after the inclusion visit.
clinical asthma profile : comorbidities
comorbidities
Measured: maximum 4 weeks after the inclusion visit.
clinical asthma profile : increased factors related to asthma.
increased factors related to asthma.
Measured: maximum 4 weeks after the inclusion visit.
biological asthma profile :blood eosinophils
blood eosinophils
Measured: maximum 4 weeks after the inclusion visit.
biological asthma profile : blood periostin
blood periostin
Measured: maximum 4 weeks after the inclusion visit.
biological asthma profile : allergologic patch test
allergologic patch test
Measured: maximum 4 weeks after the inclusion visit.
biological asthma profile : IgE analysis
IgE analysis
Measured: maximum 4 weeks after the inclusion visit.
morphological asthma profile : Chest X Ray (tomodensitometric test).
Chest X Ray (tomodensitometric test).
Measured: maximum 4 weeks after the inclusion visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2015 (estimated)
- Study startFeb 2016
- Primary completionJul 2017
- Study completionJul 2017
Why it stopped: difficulties of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ASTHMAStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- GILLES DEVOUASSOUX, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02593279
- Sponsor's protocol ID
- 69HCL14_0212
- Acronym
- AVAD
- Status last verified
- Jan 2019
- First submitted
- 28 Oct 2015
- Last updated
- 23 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AVAD: Asthma With Small Airways Dysfunction. Clinical, Immunobiological, Tomodensitometric Description, Genetic Signature Compared With Asthmatic Population With Proximal Airways Obstruction
- ClinicalTrials.gov ID
- NCT02593279
- Acronym / sponsor ID
- AVAD / 69HCL14_0212
- Conditions
- ASTHMA
- Keywords
- Asthma, phenotype, small, airway, proximal, dysfunction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficulties of enrollment
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Feb 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 2 Nov 2015 (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.
The aim of the study is to describe asthma phenotype with small airways dysfunction, in a multiparametric manner, with clinical, biological, morphological and genetic elements compared with asthma with proximal airways obstruction.
The objective of this study is also to complete the clinical, immunobiological and morphological analysis of asthma with small airways dysfunction.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| asthma with proximal or diffuse lung damage | Active comparator | Genetic: asthma with proximal airways obstruction phenotype profile description with clinical, biological, morphologic and genetic elements. |
| asthma with small airway prevailing damage | Experimental | Genetic: asthma with small airways dysfunction phenotype profile description with clinical, biological, morphologic and genetic elements. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| asthma with proximal airways obstruction phenotype profile description with clinical, biological, morphologic and genetic elements.symptoms, medical history, date of start, date of aggravation, comorbidities, increased factors related to asthma, blood eosinophils, blood periostin, allergologic patch test, igE analysis, tomodensitometric test. | Genetic | asthma with proximal or diffuse lung damage |
| asthma with small airways dysfunction phenotype profile description with clinical, biological, morphologic and genetic elements.symptoms, medical history, date of start, date of aggravation, comorbidities, increased factors related to asthma, blood eosinophils, blood periostin, allergologic patch test, IgE analysis, tomodensitometric test. | Genetic | asthma with small airway prevailing damage |
Primary outcome
mRNA expression levels.
Time frame: maximum 4 weeks after the inclusion visit.
mRNA expression levels will be measured by microarray analysis.
11 secondary outcomes
clinical asthma profile : symptoms
Time frame: maximum 4 weeks after the inclusion visit.
clinical asthma profile : medical history
Time frame: maximum 4 weeks after the inclusion visit.
clinical asthma profile : date of start
Time frame: maximum 4 weeks after the inclusion visit.
clinical asthma profile : date of aggravation
Time frame: maximum 4 weeks after the inclusion visit.
clinical asthma profile : comorbidities
Time frame: maximum 4 weeks after the inclusion visit.
clinical asthma profile : increased factors related to asthma.
Time frame: maximum 4 weeks after the inclusion visit.
biological asthma profile :blood eosinophils
Time frame: maximum 4 weeks after the inclusion visit.
biological asthma profile : blood periostin
Time frame: maximum 4 weeks after the inclusion visit.
biological asthma profile : allergologic patch test
Time frame: maximum 4 weeks after the inclusion visit.
biological asthma profile : IgE analysis
Time frame: maximum 4 weeks after the inclusion visit.
morphological asthma profile : Chest X Ray (tomodensitometric test).
Time frame: maximum 4 weeks after the inclusion visit.
Results and safety
The study was stopped early (reason given: difficulties of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2019.
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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.
GILLES DEVOUASSOUX, Pr principal investigator
Hospices Civils de Lyon
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing asthma with proximal airways obstruction phenotype profile description with clinical, biological, morphologic and genetic elements. and asthma with small airways dysfunction phenotype profile description with clinical, biological, morphologic and genetic elements. in people with ASTHMA, run by Hospices Civils de Lyon at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 23 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 was stopped early (reason given: difficulties of enrollment). Results are not available in the source record.
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?
mRNA expression levels. (time frame: maximum 4 weeks after the inclusion visit.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jan 2019.