AsthmaECENVIRNCT02212483
Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients
A study testing First home intervention with advice, First home intervention without any advice and Final home visit in people with Asthma, run by Rennes University Hospital at 16 sites in France.
Trial summary
Asthma is one of the most prevalent chronic respiratory diseases, with potential lifethreatening impacts. Indeed, asthma is still responsible for about a thousand deceases per year in France, and constitutes a public health problem in our country as in many countries in the world. Read more about this study
- Who is it for?
- Ages 6 to 44 years
- Conditions the study is for
- Asthma
- What is being tested?
- First home intervention with advice, First home intervention without any advice and Final home visit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 107 participants
- Where
- 16 sitesFrance
- Study dates
- 5 Sep 2014to 5 Mar 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 6 to 44 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- age greater than or equal to 6 years and less than 45 (<45 years),
- patients with an eligible control level of asthma,
- sensitization to one or more allergens demonstrated during the last 36 months with prick tests (papules with a diameter > 3 mm compared to a negative control or > 50% of positive control) and/or specific IgE detection (> 0.10 U/mL),
- patients > 15 years presenting with a reversibility to ß2-agonists > 200 mL and/or > 12% compared to the initial FEV1 value (test performed at least once in life) or patients ≥ 6 years and ≤ 15 years presenting with a reversibility to ß2-agonists > 200 mL and/or > 12% compared to the initial FEV1 value (at least once in the life) and/or a positive metacholine challenge (at least once in the life),
- patients sleeping > 6 nights per week in the same house
- individuals affiliated to 1 of the 3 French social security (for matching data from French social security via SNIIRAM system),
- Only one patient per dwelling,
- Patient oral consent (written attestation by investigator)
Who cannot join
- chronic obstructive pulmonary disease (COPD),
- identified occupational asthma,
- Move within the 6 months before home intervention or predicted during the first year of inclusion,
- advices provided during the 2 years before inclusion during a home intervention of a MIEC
- active smokers or smoker who given up smoking less than 5 years ago, with a consumption of more than 10 years of 20 cigarettes/day, OR smoker who given up smoking more than 5 years ago, with a consumption of more than 20 years of 20 cigarettes/day,
- patients < 18 years for whom the parents (or legal guardian) are opposed to the inclusion in ECENVIR study,
- Major people being the object of a legal protection (protection(saving) of justice, guardianship, supervision(guardianship)) and private persons of freedom
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
France16 sites
Aix-en-Provence Hospital
Aix-en-Provence, 13616
Bordeaux University Hospital
Bordeaux, 33076
Caen University Hospital
Caen, 14033
Chalon
Chalon-sur-Saône, 71100
Chauny Hospital
Chauny
Dijon University Hospital
Dijon, 21079
Grenoble University Hospital
Grenoble, 38700
Lille UH
Lille
Macon Hospital
Mâcon, 71018
Marseille European Hospital
Marseille, 13003
Marseille University Hospital
Marseille, 13915
Nantes University Hospital
Nantes, 44093
Reims University Hospital
Reims, 51100
Rouen University Hospital
Rouen, 76000
Strasbourg UH
Strasbourg, Alsace
Vire Hospital
Vire, 14504
About this study
Official title: Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients (ECENVIR Study)
Asthma is one of the most prevalent chronic respiratory diseases, with potential lifethreatening impacts. Indeed, asthma is still responsible for about a thousand deceases per year in France, and constitutes a public health problem in our country as in many countries in the world. The economic burden of asthma is also very high, in terms of health care, and indirect costs including lost work and lost school days.
A few international and French studies have shown a positive clinical impact of Medical Indoor Environment Counselors (MIECs) visiting homes of asthma patients, mainly pediatrics. It has been proposed that MIECs could contribute to reduce patient exposure to many allergens and irritants, among them, house dust mite allergens, formaldehyde or molds. Most of the studies that show a significant decrease of hospitalization or visit in an emergency ward for asthma are monocentric and study the eviction of 1 such identified risk factor. By contrast, meta-analysis underline that additional studies are needed to evaluate the effectiveness of these interventions in adults, in a multicentric and controlled manner, with both clinical, environmental and economical endpoints.
Read the detailed description
Methodology/Study schedule :
A prospective multicenter randomised, open label, controlled trial with blind evaluation of the primary evaluation criterion on three parallel groups of patients.
Procedures :
Home intervention of MIECs that comprise diagnostic of allergen/irritant exposure (after sampling), advices for allergen/irritant avoidance and follow up of advice compliance.
After randomisation and agreement of the patient and the family, the " intervention group " will benefit from a first home intervention of a MIEC during the 4 weeks following inclusion, then a final visit at the end of the study after 12 months.
Two comparative groups will be identified :
- the " control group " who will benefit from a first home intervention of a MIEC but without advices (only audit + sampling), then a final and a complete visit at the end of the study
- a " non intervention " group with no initial visit, but who will benefit from a complete home intervention of a MIEC at the end of the study.
Substantial modification of the 20th of June, 2016 : Modification of the design : change into a 2 parallel groups evaluation Justification: At its meeting of June 1, 2016, considering the inclusion difficulties, the Scientific Council decided to give up the "Control" group.
The study design is then : a prospective multicenter randomised, open label, controlled trial with blind evaluation of the primary evaluation criterion on three parallel groups of patients.
The objective is to recruit 50 to 70 patients by arm.
Expected findings and impact :
If our hypothesis that home intervention of MIECs are cost-effective on asthma control, then it is relevant to include such service in the medical care during the management of asthma patients with a reimbursement by the social security.
- Conditions
- Asthma
- Being tested
- First home intervention with advice, First home intervention without any advice, Final home visit
- Keywords
- Asthma, Medical Indoor Environment Counselors, Pediatric, Environment, Clinical effectiveness, Economical impact
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
First home intervention with adviceOther
A first home intervention of a MIEC during the 4 weeks following inclusion, with sampling, audit and advices.
First home intervention without any adviceOther
A first home intervention of a MIEC during the 4 weeks following inclusion, with sampling, home audit but without any advice.
Final home visitOther
Final home visit at the end of the study after 12 months, with sampling and home audit.
For the "intervention group", checking of the advice compliance. For the both comparative groups, delivery of advices.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | After randomisation and agreement of the patient and the family, the " intervention group " will benefit from a first home intervention of a MIEC during the 4 weeks following inclusion, then a final visit at the end of the study after 12 months. Receives: Other: First home intervention with advice; Other: Final home visit |
| Control group | Active comparator | The " control group " is one of the two comparative groups who will benefit from a first home intervention of a MIEC but without advices (only audit + sampling), then a final and a complete visit at the end of the study.
This group has been suppressed with the last amendment. But data of the subjects included in this group will be analyzed. Receives: Other: First home intervention without any advice; Other: Final home visit |
| Non intervention group | Other | The " non intervention " group is the second comparative group with no initial visit, but will benefit from a complete home intervention of a MIEC at the end of the study. Receives: Other: Final home visit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic pressure versus asthma control
The primary objective of this study is to assess the efficacy of home interventions of MIECs on asthma control.
Measured: 12 months
Secondary outcomes (4)
Drug consumption and medical care
One of the secondary objectives is to compare the following after home interventions of MIECs, evolution of drug consumption and medical care needed by asthmatic patients.
Measured: 12 months
Advices compliance
One of the secondary objectives is to compare the following after home interventions of MIECs : compliance with advices of MIECs.
Measured: 12 months
Quality of life questionnaire
One of the secondary objectives is to compare the following after home interventions of MIECs : quality of life before and after home intervention.
Measured: 12 months
Indoor pollutants concentrations
One of the secondary objectives is to compare the following after home interventions of MIECs : evolution of exposure to indoor pollutants in the intervention group.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2014 (estimated)
- Study start5 Sep 2014
- Primary completion31 Dec 2018
- Study completion5 Mar 2020
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 Rennes 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ecole des Hautes Etudes en Santé Publique, Institut de Recherche et Documentation en Economie de la Santé, France, Institut National de la Santé Et de la Recherche Médicale, France
- Responsible party
- Sponsor
- Investigators
- Jean-Pierre Gangneux, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02212483
- Sponsor's protocol ID
- 35RC12_9713_ECENVIR
- Other IDs
- 2012-A01414-39, 12/42-875, 13.424, 913428
- Acronym
- ECENVIR
- Status last verified
- May 2023
- First submitted
- 5 Aug 2014
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Le Cann P, Paulus H, Glorennec P, Le Bot B, Frain S, Gangneux JP. Home Environmental Interventions for the Prevention or Control of Allergic and Respiratory Diseases: What Really Works. J Allergy Clin Immunol Pract. 2017 Jan-Feb;5(1):66-79. doi: 10.1016/j.jaip.2016.07.011. Epub 2016 Sep 21.
PubMed 27665387Gangneux JP, Bouvrais M, Frain S, Morel H, Deguen S, Chevrier S, Le Cann P. Asthma and Indoor Environment: Usefulness of a Global Allergen Avoidance Method on Asthma Control and Exposure to Molds. Mycopathologia. 2020 Apr;185(2):367-371. doi: 10.1007/s11046-019-00417-9. Epub 2020 Jan 2.
PubMed 31897973
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Effectiveness and Economical Impact of Medical Indoor Environment Counselors Visiting Homes of Asthma Patients (ECENVIR Study)
- ClinicalTrials.gov ID
- NCT02212483
- Acronym / sponsor ID
- ECENVIR / 35RC12_9713_ECENVIR
- Conditions
- Asthma
- Keywords
- Asthma, Medical Indoor Environment Counselors, Pediatric, Environment, Clinical effectiveness, Economical impact
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Collaborators
- Ecole des Hautes Etudes en Santé Publique, Institut de Recherche et Documentation en Economie de la Santé, France, Institut National de la Santé Et de la Recherche Médicale, France
- Study start
- 5 Sep 2014 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 8 Aug 2014 (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 one of the most prevalent chronic respiratory diseases, with potential lifethreatening impacts. Indeed, asthma is still responsible for about a thousand deceases per year in France, and constitutes a public health problem in our country as in many countries in the world. The economic burden of asthma is also very high, in terms of health care, and indirect costs including lost work and lost school days.
A few international and French studies have shown a positive clinical impact of Medical Indoor Environment Counselors (MIECs) visiting homes of asthma patients, mainly pediatrics. It has been proposed that MIECs could contribute to reduce patient exposure to many allergens and irritants, among them, house dust mite allergens, formaldehyde or molds. Most of the studies that show a significant decrease of hospitalization or visit in an emergency ward for asthma are monocentric and study the eviction of 1 such identified risk factor. By contrast, meta-analysis underline that additional studies are needed to evaluate the effectiveness of these interventions in adults, in a multicentric and controlled manner, with both clinical, environmental and economical endpoints.
Detailed description
Methodology/Study schedule :
A prospective multicenter randomised, open label, controlled trial with blind evaluation of the primary evaluation criterion on three parallel groups of patients.
Procedures :
Home intervention of MIECs that comprise diagnostic of allergen/irritant exposure (after sampling), advices for allergen/irritant avoidance and follow up of advice compliance.
After randomisation and agreement of the patient and the family, the " intervention group " will benefit from a first home intervention of a MIEC during the 4 weeks following inclusion, then a final visit at the end of the study after 12 months.
Two comparative groups will be identified :
- the " control group " who will benefit from a first home intervention of a MIEC but without advices (only audit + sampling), then a final and a complete visit at the end of the study
- a " non intervention " group with no initial visit, but who will benefit from a complete home intervention of a MIEC at the end of the study.
Substantial modification of the 20th of June, 2016 : Modification of the design : change into a 2 parallel groups evaluation Justification: At its meeting of June 1, 2016, considering the inclusion difficulties, the Scientific Council decided to give up the "Control" group.
The study design is then : a prospective multicenter randomised, open label, controlled trial with blind evaluation of the primary evaluation criterion on three parallel groups of patients.
The objective is to recruit 50 to 70 patients by arm.
Expected findings and impact :
If our hypothesis that home intervention of MIECs are cost-effective on asthma control, then it is relevant to include such service in the medical care during the management of asthma patients with a reimbursement by the social security.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: First home intervention with advice, Other: Final home visitAfter randomisation and agreement of the patient and the family, the " intervention group " will benefit from a first home intervention of a MIEC during the 4 weeks following inclusion, then a final visit at the end of the study after 12 months. |
| Control group | Active comparator | Other: First home intervention without any advice, Other: Final home visitThe " control group " is one of the two comparative groups who will benefit from a first home intervention of a MIEC but without advices (only audit + sampling), then a final and a complete visit at the end of the study. This group has been suppressed with the last amendment. But data of the subjects included in this group will be analyzed. |
| Non intervention group | Other | Other: Final home visitThe " non intervention " group is the second comparative group with no initial visit, but will benefit from a complete home intervention of a MIEC at the end of the study. |
Who may qualify
- Ages
- 6 to 44 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- age greater than or equal to 6 years and less than 45 (<45 years),
- patients with an eligible control level of asthma,
- sensitization to one or more allergens demonstrated during the last 36 months with prick tests (papules with a diameter > 3 mm compared to a negative control or > 50% of positive control) and/or specific IgE detection (> 0.10 U/mL),
- patients > 15 years presenting with a reversibility to ß2-agonists > 200 mL and/or > 12% compared to the initial FEV1 value (test performed at least once in life) or patients ≥ 6 years and ≤ 15 years presenting with a reversibility to ß2-agonists > 200 mL and/or > 12% compared to the initial FEV1 value (at least once in the life) and/or a positive metacholine challenge (at least once in the life),
- patients sleeping > 6 nights per week in the same house
Key exclusion criteria (7 listed)
- chronic obstructive pulmonary disease (COPD),
- identified occupational asthma,
- Move within the 6 months before home intervention or predicted during the first year of inclusion,
- advices provided during the 2 years before inclusion during a home intervention of a MIEC
- active smokers or smoker who given up smoking less than 5 years ago, with a consumption of more than 10 years of 20 cigarettes/day, OR smoker who given up smoking more than 5 years ago, with a consumption of more than 20 years of 20 cigarettes/day,
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 |
|---|---|---|
| First home intervention with adviceA first home intervention of a MIEC during the 4 weeks following inclusion, with sampling, audit and advices. | Other | Intervention group |
| First home intervention without any adviceA first home intervention of a MIEC during the 4 weeks following inclusion, with sampling, home audit but without any advice. | Other | Control group |
| Final home visitFinal home visit at the end of the study after 12 months, with sampling and home audit. For the "intervention group", checking of the advice compliance. For the both comparative groups, delivery of advices. | Other | Control group, Intervention group, Non intervention group |
Primary outcome
Therapeutic pressure versus asthma control
Time frame: 12 months
The primary objective of this study is to assess the efficacy of home interventions of MIECs on asthma control.
4 secondary outcomes
Drug consumption and medical care
Time frame: 12 months
Advices compliance
Time frame: 12 months
Quality of life questionnaire
Time frame: 12 months
Indoor pollutants concentrations
Time frame: 12 months
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 24 May 2023.
- Results publication: PubMed 27665387Le Cann P, Paulus H, Glorennec P, Le Bot B, Frain S, Gangneux JP. Home Environmental Interventions for the Prevention or Control of Allergic and Respiratory Diseases: What Really Works. J Allergy Clin Immunol Pract. 2017 Jan-Feb;5(1):66-79. doi: 10.1016/j.jaip.2016.07.011. Epub 2016 Sep 21.
- Results publication: PubMed 31897973Gangneux JP, Bouvrais M, Frain S, Morel H, Deguen S, Chevrier S, Le Cann P. Asthma and Indoor Environment: Usefulness of a Global Allergen Avoidance Method on Asthma Control and Exposure to Molds. Mycopathologia. 2020 Apr;185(2):367-371. doi: 10.1007/s11046-019-00417-9. Epub 2020 Jan 2.
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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.
Jean-Pierre Gangneux, MD principal investigator
Rennes University Hospital
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing First home intervention with advice, First home intervention without any advice and Final home visit in people with Asthma, run by Rennes University Hospital at 16 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?
The sponsor lists 8 inclusion and 7 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 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 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 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?
Therapeutic pressure versus asthma control (time frame: 12 months). 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 NCT02212483, 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 24 May 2023.