AsthmaPATURE IVNCT02929277
Protection Against Allergy: Study in Rural Environment - Part IV
A study testing blood sampling, skin prick tests, assesment of atopic dermatitis, questionnaires in people with Asthma and Atopy, run by Centre Hospitalier Universitaire de Besancon.
Trial summary
PASTURE is a birth cohort of children born to farm and non-farm women from rural areas across Europe. Five study centres Austria, Germany, Switzerland, France and Finland enrolled 1133 children (farmers in about half of the children) to study the origins of asthma and atopy and to develop potential preventive… Read more about this study
- Who is it for?
- Ages 10 to 11 years
- What is being tested?
- blood sampling, skin prick tests, assesment of atopic dermatitis, questionnaires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to 6 May 2015
- 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 10 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- PATURE IV is a birth cohort. All children enrolled at the beginning and who still agree to participate will be included at 10-year follow-up.
Who cannot join
- -
About this study
PASTURE is a birth cohort of children born to farm and non-farm women from rural areas across Europe. Five study centres Austria, Germany, Switzerland, France and Finland enrolled 1133 children (farmers in about half of the children) to study the origins of asthma and atopy and to develop potential preventive strategies.
Previous results show a protective effect of farm exposure on allergic risk by livestock contacts and microbial exposures and by raw cow milk consumption in early age.
PASTURE Part IV is the 10-year follow up of this birth cohort. The primary objective is to characterize the allergic phenotype between 6 and 10 years old (asthma and allergic rhinitis) and to explain how early age exposures and particularly milk products consumption contribute in the process of allergic illness in childhood. A focus on the characterization of the protective biologically active components in raw milk and identification of immunological mechanisms are involved.
- Being tested
- blood sampling, skin prick tests, assesment of atopic dermatitis, questionnaires
- Keywords
- farm children, non-farm children
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sampling, skin prick tests, assesment of atopic dermatitis, questionnairesOther
| Study group | Role | What they receive |
|---|---|---|
| single arm study | Other | Not described Receives: Other: blood sampling, skin prick tests, assesment of atopic dermatitis, questionnaires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma
Measured: 10 years old
Rhinitis
Measured: 10 years old
Atopic Dermatitis
Measured: 10 years old
Food Allergy
Measured: 10 years old
Skin prick tests
Measured: 10 years old
Specific Immunoglobulin E (IgEs)
Measured: 10 years old
Blood cytokine profiles
Measured: 10 years old
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study startOct 2013
- Primary completionMay 2015
- Study completion6 May 2015
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 Centre Hospitalier Universitaire de BesanconThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929277
- Sponsor's protocol ID
- R/2012/47
- Acronym
- PATURE IV
- Status last verified
- Oct 2016
- First submitted
- 30 Sep 2016
- Last updated
- 30 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Chauveau A, Dalphin ML, Mauny F, Kaulek V, Schmausser-Hechfellner E, Renz H, Riedler J, Pekkanen J, Karvonen AM, Lauener R, Roduit C, Vuitton DA, von Mutius E, Dalphin JC; PASTURE Study Group. Skin prick tests and specific IgE in 10-year-old children: Agreement and association with allergic diseases. Allergy. 2017 Sep;72(9):1365-1373. doi: 10.1111/all.13148. Epub 2017 Apr 12.
PubMed 28235151Chauveau A, Dalphin ML, Kaulek V, Roduit C, Pugin A, von Mutius E, Vuitton DA, Dalphin JC. Disagreement between Skin Prick Tests and Specific IgE in Early Childhood. Int Arch Allergy Immunol. 2016;170(2):69-74. doi: 10.1159/000446776. Epub 2016 Jul 26.
PubMed 27454436
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protection Against Allergy: Study in Rural Environment - Part IV
- ClinicalTrials.gov ID
- NCT02929277
- Acronym / sponsor ID
- PATURE IV / R/2012/47
- Keywords
- farm children, non-farm children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- May 2015 (actual)
- Study completion
- 6 May 2015 (actual)
- First posted
- 11 Oct 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.
PASTURE is a birth cohort of children born to farm and non-farm women from rural areas across Europe. Five study centres Austria, Germany, Switzerland, France and Finland enrolled 1133 children (farmers in about half of the children) to study the origins of asthma and atopy and to develop potential preventive strategies.
Previous results show a protective effect of farm exposure on allergic risk by livestock contacts and microbial exposures and by raw cow milk consumption in early age.
PASTURE Part IV is the 10-year follow up of this birth cohort. The primary objective is to characterize the allergic phenotype between 6 and 10 years old (asthma and allergic rhinitis) and to explain how early age exposures and particularly milk products consumption contribute in the process of allergic illness in childhood. A focus on the characterization of the protective biologically active components in raw milk and identification of immunological mechanisms are involved.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| single arm study | Other | Other: blood sampling, skin prick tests, assesment of atopic dermatitis, questionnaires |
Who may qualify
- Ages
- 10 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- PATURE IV is a birth cohort. All children enrolled at the beginning and who still agree to participate will be included at 10-year follow-up.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| blood sampling, skin prick tests, assesment of atopic dermatitis, questionnaires | Other | single arm study |
Primary outcome
Asthma
Time frame: 10 years old
Rhinitis
Time frame: 10 years old
Atopic Dermatitis
Time frame: 10 years old
Food Allergy
Time frame: 10 years old
Skin prick tests
Time frame: 10 years old
Specific Immunoglobulin E (IgEs)
Time frame: 10 years old
Blood cytokine profiles
Time frame: 10 years old
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 30 Jul 2018.
- Results publication: PubMed 28235151Chauveau A, Dalphin ML, Mauny F, Kaulek V, Schmausser-Hechfellner E, Renz H, Riedler J, Pekkanen J, Karvonen AM, Lauener R, Roduit C, Vuitton DA, von Mutius E, Dalphin JC; PASTURE Study Group. Skin prick tests and specific IgE in 10-year-old children: Agreement and association with allergic diseases. Allergy. 2017 Sep;72(9):1365-1373. doi: 10.1111/all.13148. Epub 2017 Apr 12.
- Results publication: PubMed 27454436Chauveau A, Dalphin ML, Kaulek V, Roduit C, Pugin A, von Mutius E, Vuitton DA, Dalphin JC. Disagreement between Skin Prick Tests and Specific IgE in Early Childhood. Int Arch Allergy Immunol. 2016;170(2):69-74. doi: 10.1159/000446776. Epub 2016 Jul 26.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing blood sampling, skin prick tests, assesment of atopic dermatitis, questionnaires in people with Asthma and Atopy, run by Centre Hospitalier Universitaire de Besancon.
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 1 inclusion and 1 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 30 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Asthma (time frame: 10 years old). The study lists 7 primary outcomes in all. 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 NCT02929277, 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 30 Jul 2018.