Non-atopic AsthmaGANANCT02911220
Genetic Study of Familial Forms of Non-atopic Asthma
A study testing demonstration of genetic mutations causing non-atopic asthma in people with Non-atopic Asthma and Genetic Study, run by Nantes University Hospital at 1 site in France.
Trial summary
The intrinsic asthma (atopic or not) is a particular phenotype marked by an early later symptoms, increased severity, sensitivity associated with nonsteroidal anti-inflammatory drugs (NSAIDs), a sinonasal polyposis and eosinophilia. Unlike allergic asthma, this form does not today demonstrated its genetic character. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Non-atopic Asthma, Genetic Study
- What is being tested?
- demonstration of genetic mutations causing non-atopic asthma
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- 26 Feb 2020to 26 Feb 2020
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- index case:
- Major
- Lack of respiratory disease documented in the medical record other than asthma
- Severe Asthma by definition ATS / ERS 2014:
- Treatment with high doses of CI and beta2 agonists for long-acting (B2LDA) or anti leukotriene or theophylline during the previous year or oral corticosteroids (CO) more than 50% from the previous year to prevent loss of control asthma.
- Asthma "uncontrolled" (at least 1 criteria):
Show all 14Show fewer
- ACT <20 and / or ACQ> 1.5 (Asthma Control Test)
- 2 courses or more CO in the previous year
- 1 hospitalization for asthma in the previous year
- FEV <80% predicted despite bronchodilators.
- Examination or medical record to find at least one member of the genetically non-atopic asthma associated family
- Prick negative tests for common allergens, questionnaire seeking negative atopy (SFAR Love) Phadiatop or negative diagnosis of non-atopic asthma confirmed by the adjudication committee
- informed and written consent of the patient to participate in the study
- Affiliated to a social security scheme
Who cannot join
- Pregnant women
- Minors
- Known associated respiratory pathologies (COPD, bronchial dilatation, diffuse infiltrating pneumopathy)
- Major Trust
- Subject having demonstrated the inability or refusal to sign an informed consent
- Relatives' patients:
Show all 14Show fewer
- Major
- Related to the 1st and 2nd level of the index case or another member with family
- Related with or without a asthma (atopic or non-atopic)
- Informed and written consent of the patient to participate in the study Affiliated to a social security scheme
- Pregnant women
- Minors
- Major Trust
- Subject having demonstrated the inability or refusal to sign an informed consent
Trial locations and contacts
1 site in 1 country.
About this study
The intrinsic asthma (atopic or not) is a particular phenotype marked by an early later symptoms, increased severity, sensitivity associated with nonsteroidal anti-inflammatory drugs (NSAIDs), a sinonasal polyposis and eosinophilia.
Unlike allergic asthma, this form does not today demonstrated its genetic character. However, the existence of familial forms of asthma in this region Pays de La Loire led us to hypothesize the existence of genetic variations can explain some familial forms of non-atopic asthma. Corresponding genes may be relevant to understanding the pathophysiological pathways involved in the more common sporadic forms.
Read more
The investigators propose a study combining genetic linkage analysis and complete sequencing exomes to identify one or more genetic abnormalities associated with non-atopic asthma. The clinical stage essential for mutation identification is to identify and recruit large families with members affected by non-atopic asthma and ensure accurate phenotyping of all individuals recruited over several generations.
The aim of this study is to create a cohort of families who have more members within them non-atopic asthma. A high genetic combined exome sequencing throughput analysis in a family linkage study will then reveal the presence or absence of genetic variations associated with intrinsic asthma.
Read the detailed description
Patients with non-atopic asthma will be identified in consultation pulmonology at Laennec Hospital (CHU Nantes) from the consultant population to severe asthma.
These patients will be treated as index case.
The investigator will conduct a family tree of the index case to identify families where the number of healthy individuals and those with non-atopic asthma makes relevant a family genetic study. Before initiating the family screening, it is necessary to have notion of at least two individuals carrying non-atopic asthma at least two generations in the family.
Related agreeing to participate in this study will be included.
- Conditions
- Non-atopic Asthma, Genetic Study
- Being tested
- demonstration of genetic mutations causing non-atopic asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
demonstration of genetic mutations causing non-atopic asthmaGenetic
recruitment of familial forms of non-atopic asthma (patients with non-atopic asthma and their relatives) to perform genetic analysis of exome sequencing
| Study group | Role | What they receive |
|---|---|---|
| blood sample for genetic evaluation | Other | a blood sample is collected once for genetic analysis Receives: Genetic: demonstration of genetic mutations causing non-atopic asthma |
What is being measured
The primary outcome is the main question the study is designed to answer.
broadband genetic and fine characterization of the phenotype in familial forms.
Measured: 36 months
Secondary outcomes (1)
Identification of a homogeneous group of non-atopic asthma patients
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2016 (estimated)
- Study start26 Feb 2020
- Primary completion26 Feb 2020
- Study completion26 Feb 2020
Why it stopped: not enough available families to get significant genetic results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-atopic AsthmaStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02911220
- Sponsor's protocol ID
- RC15_0354
- Other IDs
- 2016-A00922-49
- Acronym
- GANA
- Status last verified
- Jan 2021
- First submitted
- 9 Sep 2016
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Study of Familial Forms of Non-atopic Asthma
- ClinicalTrials.gov ID
- NCT02911220
- Acronym / sponsor ID
- GANA / RC15_0354
- Conditions
- Non-atopic Asthma, Genetic Study
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough available families to get significant genetic results
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 26 Feb 2020 (actual)
- Primary completion
- 26 Feb 2020 (actual)
- Study completion
- 26 Feb 2020 (actual)
- First posted
- 22 Sep 2016 (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 intrinsic asthma (atopic or not) is a particular phenotype marked by an early later symptoms, increased severity, sensitivity associated with nonsteroidal anti-inflammatory drugs (NSAIDs), a sinonasal polyposis and eosinophilia.
Unlike allergic asthma, this form does not today demonstrated its genetic character. However, the existence of familial forms of asthma in this region Pays de La Loire led us to hypothesize the existence of genetic variations can explain some familial forms of non-atopic asthma. Corresponding genes may be relevant to understanding the pathophysiological pathways involved in the more common sporadic forms.
The investigators propose a study combining genetic linkage analysis and complete sequencing exomes to identify one or more genetic abnormalities associated with non-atopic asthma. The clinical stage essential for mutation identification is to identify and recruit large families with members affected by non-atopic asthma and ensure accurate phenotyping of all individuals recruited over several generations.
The aim of this study is to create a cohort of families who have more members within them non-atopic asthma. A high genetic combined exome sequencing throughput analysis in a family linkage study will then reveal the presence or absence of genetic variations associated with intrinsic asthma.
Detailed description
Patients with non-atopic asthma will be identified in consultation pulmonology at Laennec Hospital (CHU Nantes) from the consultant population to severe asthma.
These patients will be treated as index case.
The investigator will conduct a family tree of the index case to identify families where the number of healthy individuals and those with non-atopic asthma makes relevant a family genetic study. Before initiating the family screening, it is necessary to have notion of at least two individuals carrying non-atopic asthma at least two generations in the family.
Related agreeing to participate in this study will be included.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| blood sample for genetic evaluation | Other | Genetic: demonstration of genetic mutations causing non-atopic asthmaa blood sample is collected once for genetic analysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- index case:
- Treatment with high doses of CI and beta2 agonists for long-acting (B2LDA) or anti leukotriene or theophylline during the previous year or oral corticosteroids (CO) more than 50% from the previous year to prevent loss of control asthma.
- Asthma "uncontrolled" (at least 1 criteria):
- Examination or medical record to find at least one member of the genetically non-atopic asthma associated family
- Prick negative tests for common allergens, questionnaire seeking negative atopy (SFAR Love) Phadiatop or negative diagnosis of non-atopic asthma confirmed by the adjudication committee
Key exclusion criteria (14 listed)
- Pregnant women
- Minors
- Major Trust
- Subject having demonstrated the inability or refusal to sign an informed consent
- Major
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 |
|---|---|---|
| demonstration of genetic mutations causing non-atopic asthmarecruitment of familial forms of non-atopic asthma (patients with non-atopic asthma and their relatives) to perform genetic analysis of exome sequencing | Genetic | blood sample for genetic evaluation |
Primary outcome
broadband genetic and fine characterization of the phenotype in familial forms.
Time frame: 36 months
1 secondary outcome
Identification of a homogeneous group of non-atopic asthma patients
Time frame: 36 months
Results and safety
The study was stopped early (reason given: not enough available families to get significant genetic results). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing demonstration of genetic mutations causing non-atopic asthma in people with Non-atopic Asthma and Genetic Study, run by Nantes University Hospital 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 14 inclusion and 14 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: stopped early, as of the sponsor's last update on 20 Jan 2021. 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 was stopped early (reason given: not enough available families to get significant genetic results). 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?
broadband genetic and fine characterization of the phenotype in familial forms. (time frame: 36 months). 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 20 Jan 2021.