Childhood AsthmaAsthmaVentNCT02068573
AsthmaVent - Effect of Mechanical Ventilation on Asthma Control in Children
A study testing Ventilation in people with Childhood Asthma and Allergy, run by University of Aarhus at 7 sites in Denmark.
Trial summary
AsthmaVent is a multi-center study, investigating the association between indoor air quality and childhood asthma. In Denmark, we spend more and more time indoors. Our houses are built airtight to save energy and are difficult to ventilate. We are thus more exposed to our indoor air than ever before. Read more about this study
- Who is it for?
- Ages 5 to 18 years
- Conditions the study is for
- Childhood Asthma, Allergy
- What is being tested?
- Ventilation
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 46 participants
- Where
- 7 sitesDenmark
- Study dates
- Aug 2012to Feb 2016
- 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 5 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Doctors diagnosed asthma
- Need of inhaled steroid titrated down to at least 400 microg/day of Budesonide or equivalent dose of other corticosteroid
- Skin prick test >/= 3 mm or specific IgE >/= 0,7 kU/l to house dust mites (Derm. Pteronyssinus and/or Derm. Farinae)
- more than 500 nanog/gr dust of house dust mite allergen in the childs mattress.
- Living in a one-family house and will allow changes of the house during the intervention period.
- Capable of giving informed consent.
Who cannot join
- Other clinically relevant allergies to tree pollen or animals present in the house.
- Other diseases or treatments, as for example immunotherapy, which could influence the results.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Denmark7 sites
Childrens Department, Aarhus University Hospital
Aarhus, Region Midt, 8200
Børneafdelingen Herlev Hospital
Herlev, Capital Region, 2730
Childrens Department, Herning Hospital
Herning, Region Midt, 7400
Childrens Department, Hillerød hospital
Hillerød, Region Nordsjælland, 3400
Childrens Department, Kolding Hospital
Kolding, Region Syddanmark, 6000
H.C. Andersens Children Hospital, Odense University Hospital
Odense, Region Syddanmark, 5000
Childrens DEpartment, Randers Hospital
Randers, Region Midt, 8930
About this study
AsthmaVent is a multi-center study, investigating the association between indoor air quality and childhood asthma.
In Denmark, we spend more and more time indoors. Our houses are built airtight to save energy and are difficult to ventilate. We are thus more exposed to our indoor air than ever before. We know that indoor air contains many different components that can affect our airways inappropriately and particularly children with asthma, who have sensitive airways are sensitive to these components. The AsthmaVent project examines whether increased ventilation is able to improve the indoor environment to such an extent that the asthma disease control, for children with asthma and house dust mite allergy improves, resulting in need for less medication.
Read more
Previous studies have pointed towards a beneficial effect of mechanical ventilation, on both the indoor air quality and on children's health and quality of life. There is not currently a consensus in this area, as studies so far have not been large or good enough to confidently determine the effect.
This project is big and is designed so that it takes into account the sources of error seen in previous studies on the topic.
We include, over a 3-year period (2012-2014), a total of 80 children with asthma and house dust mite allergy aged 6-18 years, from pediatric departments in Aarhus, Odense, Kolding, Randers and Herning. They are divided into two groups, receiving either active ventilation or placebo ventilation, meaning a non-functioning ventilation system that just recirculates the air in the room. Ventilation systems are installed in the fall and winter and ventilate the child's bedroom during 9 months. Indoor air quality and asthma control are assessed every 3 months, both at home visits were air quality and allergen levels of house dust mites are studies and at visits to the outpatient clinics with control of asthma parameters and quality of life.
The project involves collaboration between several institutions with an interest in indoor air quality in relation to allergies and asthma and with great expertise in the field.The project was initiated by CISBO (Centre for Indoor Environment and Health in Dwellings), a center consisting of several institutions in Denmark dealing with indoor environment: Department of Public Health at Aarhus University and University of Copenhagen, Danish Building Research Institute and the Technical University of Denmark.
Since asthma is the most common chronic childhood disease in Denmark and since the development of allergies and asthma has high social and personal costs, it is important for both society and the individual family, to find out whether simply improving the indoor air quality by increased ventilation can lead to an improvement in asthma disease control.
Read the detailed description
The aim of the project is to investigate whether increased ventilation is able to improve the indoor air quality and thereby asthma disease control for children with asthma and house dust mite allergy.
Hypotheses:
- An increased ventilation in the home will reduce the need for inhaled steroids in children with house dust mite allergy and asthma.
- An increased ventilation in the home will improve the quality of life in children with house dust mite allergy and asthma.
- An increased ventilation in the home will improve the indoor environment and thus improve asthma disease control in children with house dust mite allergy and asthma.
Materials and methods: The study is a randomized double-blind placebo-controlled intervention study. The intervention is balanced mechanical ventilation in the bedroom of children with asthma and house dust mite allergy during 9-months.
Population: Over 3 year period (2012-2014) 80 families with asthmatic children aged 6-18 years will be included from out-patient clinics at the children's department of the University Hospitals of Aarhus and Odense and regional hospitals in Kolding, Randers and Herning. Families will also be included from private pediatric clinics in Aarhus.
Randomization: After inclusion children are randomized to either active ventilation or placebo ventilation. Randomization is done in blocks of 4 by center.
Intervention: The ventilation units Type DUPLEX 370 EC4.D and DUPLEX 370 are installed during the fall and run continuously for 9 months. The ventilation system is placed outside the house and provides filtered conditioned air to the child's bedroom, through insulated pipes mounted in a window opening. The window opening was built specifically for this purpose in form of a thermo plate replacing the window glass. The unit provides the bedroom with at least 2-3 air changes per hour. The placebo unit (DUPLEX 370) is a completely similar installation which only recirculates the air in the room instead of replacing it. We recommend all parents to wash the duvet and pillow every 3 months.
Data collection:
Data on the children's health is collected every 3 months when the families visit the outpatient clinics. The children are seen by specialist doctors.
At home visits, also every 3 months, data concerning the indoor air quality is collected.
- Conditions
- Childhood Asthma, Allergy
- Being tested
- Ventilation, Placebo Ventilation
- Keywords
- Childhood Asthma, Allergy, House dust mites, Indoor air quality
- Medical subject headings
- Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VentilationDevice
Also called Ventilation units Type DUPLEX 370 EC4.D
The ventilation system is placed outside the house and provides filtered conditioned air to the child's bedroom, through insulated pipes mounted in a window opening. The window opening was built specifically for this purpose in form of a thermo plate replacing the window glass. The unit provides the bedroom with at least 2-3 air changes per hour
Placebo VentilationDevice
Also called Placebo ventilation unit type DUPLEX 370
The placebo unit (DUPLEX 370) is a completely similar installation to the active ventilation unit, but it only recirculates the air in the room instead of replacing it with fresh conditioned air.
| Study group | Role | What they receive |
|---|---|---|
| Ventilation | Active comparator | Increased ventilation in the childs bedroom to at least 2-3 air changes pr hour. Receives: Device: Ventilation |
| Placebo ventilation | Placebo comparator | Ventilation system that recirculates the air in the childs bedroom Receives: Device: Placebo Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in dose of inhaled corticosteroid
Measured in micrograms of a specific inhaled corticosteroid
Measured: Baseline, 3 months, 6 months and 9 months
Changes in particle concentration in child bedroom
Measured as particles pr. m3
Measured: baseline, 3 months, 6 months and 9 months
Secondary outcomes (9)
FEV1
Forced Expiratory Volume after 1 second
Measured: Baseline, 3,6 and 9 months
FeNO
Forced Expiratory Nitric Oxide
Measured: Baseline, 3,6 and 9 months
Quality of Life
Pediatric Asthma Quality of Life Questionaire
Measured: Baseline, 3,6 and 9 months
Standard Skin-prick-test and Specific IgE- phadiatop
Reduction in diameter of skin-prick-test for standard inhalant allergens and reduction in specific IgE for standard inhalant allergens measured in kU/l.
Measured: Baseline and 9 months
Asthma Symptoms
Assessed from a Symptom score scheme
Measured: During 14 days at baseline, 3, 6 and 9 months
Peakflow variability
Measured: Baseline, 3, 6 and 9 months
Ventilation rate
Ventilation rate in the childs bedroom and in the Whole house
Measured: Baseline, 3, 6 and 9 months
Physical conditions in the child bedroom and whole house
Changes in temperature and humidity
Measured: baseline, 3 6 and 9 months
Allergens in child mattress and airborne in child bedroom
Reduction in allergen levels.
Measured: baseline, 3, 6 and 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2014 (estimated)
- Study startAug 2012
- Primary completionFeb 2016
- Study completionFeb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood AsthmaStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Torben Sigsgaard, Professor, Study director, Aarhus University, Department of Public Health, Section for Environment, Occupation and HealthNina V Hogaard, MD, Principal investigator, Aarhus University, Dept. of Public Health, Section for Environment, Occupation and Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02068573
- Sponsor's protocol ID
- AstmaVen - 1101
- Acronym
- AsthmaVent
- Status last verified
- May 2016
- First submitted
- 19 Feb 2014
- Last updated
- 12 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AsthmaVent - Effect of Mechanical Ventilation on Asthma Control in Children
- ClinicalTrials.gov ID
- NCT02068573
- Acronym / sponsor ID
- AsthmaVent / AstmaVen - 1101
- Conditions
- Childhood Asthma, Allergy
- Keywords
- Childhood Asthma, Allergy, House dust mites, Indoor air quality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Feb 2016 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 21 Feb 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.
AsthmaVent is a multi-center study, investigating the association between indoor air quality and childhood asthma.
In Denmark, we spend more and more time indoors. Our houses are built airtight to save energy and are difficult to ventilate. We are thus more exposed to our indoor air than ever before. We know that indoor air contains many different components that can affect our airways inappropriately and particularly children with asthma, who have sensitive airways are sensitive to these components. The AsthmaVent project examines whether increased ventilation is able to improve the indoor environment to such an extent that the asthma disease control, for children with asthma and house dust mite allergy improves, resulting in need for less medication.
Previous studies have pointed towards a beneficial effect of mechanical ventilation, on both the indoor air quality and on children's health and quality of life. There is not currently a consensus in this area, as studies so far have not been large or good enough to confidently determine the effect.
This project is big and is designed so that it takes into account the sources of error seen in previous studies on the topic.
We include, over a 3-year period (2012-2014), a total of 80 children with asthma and house dust mite allergy aged 6-18 years, from pediatric departments in Aarhus, Odense, Kolding, Randers and Herning. They are divided into two groups, receiving either active ventilation or placebo ventilation, meaning a non-functioning ventilation system that just recirculates the air in the room. Ventilation systems are installed in the fall and winter and ventilate the child's bedroom during 9 months. Indoor air quality and asthma control are assessed every 3 months, both at home visits were air quality and allergen levels of house dust mites are studies and at visits to the outpatient clinics with control of asthma parameters and quality of life.
The project involves collaboration between several institutions with an interest in indoor air quality in relation to allergies and asthma and with great expertise in the field.The project was initiated by CISBO (Centre for Indoor Environment and Health in Dwellings), a center consisting of several institutions in Denmark dealing with indoor environment: Department of Public Health at Aarhus University and University of Copenhagen, Danish Building Research Institute and the Technical University of Denmark.
Since asthma is the most common chronic childhood disease in Denmark and since the development of allergies and asthma has high social and personal costs, it is important for both society and the individual family, to find out whether simply improving the indoor air quality by increased ventilation can lead to an improvement in asthma disease control.
Detailed description
The aim of the project is to investigate whether increased ventilation is able to improve the indoor air quality and thereby asthma disease control for children with asthma and house dust mite allergy.
Hypotheses:
- An increased ventilation in the home will reduce the need for inhaled steroids in children with house dust mite allergy and asthma.
- An increased ventilation in the home will improve the quality of life in children with house dust mite allergy and asthma.
- An increased ventilation in the home will improve the indoor environment and thus improve asthma disease control in children with house dust mite allergy and asthma.
Materials and methods: The study is a randomized double-blind placebo-controlled intervention study. The intervention is balanced mechanical ventilation in the bedroom of children with asthma and house dust mite allergy during 9-months.
Population: Over 3 year period (2012-2014) 80 families with asthmatic children aged 6-18 years will be included from out-patient clinics at the children's department of the University Hospitals of Aarhus and Odense and regional hospitals in Kolding, Randers and Herning. Families will also be included from private pediatric clinics in Aarhus.
Randomization: After inclusion children are randomized to either active ventilation or placebo ventilation. Randomization is done in blocks of 4 by center.
Intervention: The ventilation units Type DUPLEX 370 EC4.D and DUPLEX 370 are installed during the fall and run continuously for 9 months. The ventilation system is placed outside the house and provides filtered conditioned air to the child's bedroom, through insulated pipes mounted in a window opening. The window opening was built specifically for this purpose in form of a thermo plate replacing the window glass. The unit provides the bedroom with at least 2-3 air changes per hour. The placebo unit (DUPLEX 370) is a completely similar installation which only recirculates the air in the room instead of replacing it. We recommend all parents to wash the duvet and pillow every 3 months.
Data collection:
Data on the children's health is collected every 3 months when the families visit the outpatient clinics. The children are seen by specialist doctors.
At home visits, also every 3 months, data concerning the indoor air quality is collected.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ventilation | Active comparator | Device: VentilationIncreased ventilation in the childs bedroom to at least 2-3 air changes pr hour. |
| Placebo ventilation | Placebo comparator | Device: Placebo VentilationVentilation system that recirculates the air in the childs bedroom |
Who may qualify
- Ages
- 5 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Doctors diagnosed asthma
- Need of inhaled steroid titrated down to at least 400 microg/day of Budesonide or equivalent dose of other corticosteroid
- Skin prick test >/= 3 mm or specific IgE >/= 0,7 kU/l to house dust mites (Derm. Pteronyssinus and/or Derm. Farinae)
- more than 500 nanog/gr dust of house dust mite allergen in the childs mattress.
- Living in a one-family house and will allow changes of the house during the intervention period.
Key exclusion criteria (2 listed)
- Other clinically relevant allergies to tree pollen or animals present in the house.
- Other diseases or treatments, as for example immunotherapy, which could influence the results.
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 |
|---|---|---|
| VentilationAlso: Ventilation units Type DUPLEX 370 EC4.DThe ventilation system is placed outside the house and provides filtered conditioned air to the child's bedroom, through insulated pipes mounted in a window opening. The window opening was built specifically for this purpose in form of a thermo plate replacing the window glass. The unit provides the bedroom with at least 2-3 air changes per hour | Device | Ventilation |
| Placebo VentilationAlso: Placebo ventilation unit type DUPLEX 370The placebo unit (DUPLEX 370) is a completely similar installation to the active ventilation unit, but it only recirculates the air in the room instead of replacing it with fresh conditioned air. | Device | Placebo ventilation |
Primary outcome
Changes in dose of inhaled corticosteroid
Time frame: Baseline, 3 months, 6 months and 9 months
Measured in micrograms of a specific inhaled corticosteroid
Changes in particle concentration in child bedroom
Time frame: baseline, 3 months, 6 months and 9 months
Measured as particles pr. m3
9 secondary outcomes
FEV1
Time frame: Baseline, 3,6 and 9 months
FeNO
Time frame: Baseline, 3,6 and 9 months
Quality of Life
Time frame: Baseline, 3,6 and 9 months
Standard Skin-prick-test and Specific IgE- phadiatop
Time frame: Baseline and 9 months
Asthma Symptoms
Time frame: During 14 days at baseline, 3, 6 and 9 months
Peakflow variability
Time frame: Baseline, 3, 6 and 9 months
Ventilation rate
Time frame: Baseline, 3, 6 and 9 months
Physical conditions in the child bedroom and whole house
Time frame: baseline, 3 6 and 9 months
Allergens in child mattress and airborne in child bedroom
Time frame: baseline, 3, 6 and 9 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 12 May 2016.
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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.
Torben Sigsgaard, Professor study director
Aarhus University, Department of Public Health, Section for Environment, Occupation and Health
Nina V Hogaard, MD principal investigator
Aarhus University, Dept. of Public Health, Section for Environment, Occupation and Health
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ventilation in people with Childhood Asthma and Allergy, run by University of Aarhus at 7 sites in Denmark.
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 6 inclusion and 2 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 12 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Denmark. 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. Some participants in this study may receive a placebo. 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?
Changes in dose of inhaled corticosteroid (time frame: Baseline, 3 months, 6 months and 9 months). The study lists 2 primary outcomes in all. 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 12 May 2016.