AsthmaNCT00043992
Outdoor Allergen Exposure, Sensitivity, and Acute Asthma
An observational study of Asthma, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
Trial summary
To examine the role of outdoor pollen grains and fungal spores in the exacerbation of asthma and to produce forecasting models to predict days of high concentration. Read more about this study
- Who is it for?
- Ages 15 to 50 years
- Conditions the study is for
- Asthma
- How many people
- 1,000 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2001to not given
- Phase
- Observational
- 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 15 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Must be a member of the Fallon HMO and be treated for acute asthma exacerbation.
Trial locations and contacts
1 site in 1 country.
United States1 site
Fallon Clinic and Fallon Community Health Plan
Worcester, Massachusetts, 01605
About this study
To examine the role of outdoor pollen grains and fungal spores in the exacerbation of asthma and to produce forecasting models to predict days of high concentration.
Read the detailed description
Asthma is a growing problem, and outdoor allergens play a role in exacerbation of many cases. A clearer understanding of this role and its magnitude, and a means of controlling the effects of outdoor allergen exposures is needed. We propose Poisson time-series and conditional panel studies to test these hypotheses: 1) The incidence of acute asthma attacks, as measured by urgent care inhalation treatments and hospitalizations for asthma, has a dose-dependent relationship with exposure to specific outdoor allergens; 2) Specific sensitization to outdoor allergens is a risk factor for having an acute attack; and 3) Exposure conditions that lead to acute asthma attacks can be forecast, creating an opportunity to reduce asthma morbidity and mortality ny targeting pretreatment and/or exposure controls.
- Conditions
- Asthma
- Keywords
- Asthma, Allergens
- Medical subject headings
- Asthma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2002 (estimated)
- Study startJul 2001
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.
- 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
- Observational
- Observational model
- Defined population
- Time perspective
- Prospective
- Enrolment
- 1,000 participants
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00043992
- Sponsor's protocol ID
- 9744-CP-001
- Status last verified
- Sep 2006
- First submitted
- 16 Aug 2002
- Last updated
- 4 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outdoor Allergen Exposure, Sensitivity, and Acute Asthma
- ClinicalTrials.gov ID
- NCT00043992
- Acronym / sponsor ID
- 9744-CP-001
- Conditions
- Asthma
- Keywords
- Asthma, Allergens
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- Jul 2001
- First posted
- 19 Aug 2002 (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.
To examine the role of outdoor pollen grains and fungal spores in the exacerbation of asthma and to produce forecasting models to predict days of high concentration.
Detailed description
Asthma is a growing problem, and outdoor allergens play a role in exacerbation of many cases. A clearer understanding of this role and its magnitude, and a means of controlling the effects of outdoor allergen exposures is needed. We propose Poisson time-series and conditional panel studies to test these hypotheses: 1) The incidence of acute asthma attacks, as measured by urgent care inhalation treatments and hospitalizations for asthma, has a dose-dependent relationship with exposure to specific outdoor allergens; 2) Specific sensitization to outdoor allergens is a risk factor for having an acute attack; and 3) Exposure conditions that lead to acute asthma attacks can be forecast, creating an opportunity to reduce asthma morbidity and mortality ny targeting pretreatment and/or exposure controls.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 4 Sep 2006.
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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?
An observational study of Asthma, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in United States.
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: finished, as of the sponsor's last update on 4 Sep 2006. 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 United States. 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.
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 4 Sep 2006.