AsthmaERANCT01593111
Environmental Intervention Versus Standard Care to Reduce Pharmacologic Therapy for Asthma
A study testing Environmental Intervention in people with Asthma, run by Columbia University at 2 sites in United States.
Trial summary
Exposure to household allergens is a major contributor to asthma symptoms. Aggressive measures to reduce household allergens has the potential to reduce asthma symptoms and the need for medications to control asthma. Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Environmental Intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2011to Sep 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Clinical history consistent with asthma in male and female subjects ages 6 and above.
- Need for controller therapy demonstrated by current use of a stable dose (at least 4 weeks) of long term asthma controller therapy; or if not receiving long term asthma controller, symptoms consistent with persistent asthma (eg. Symptoms > 3x per week).
- Prebronchodilator FEV1 > 40% predicted at screening (V0)
- Positive skin test (defined as wheal greater than 3 mm in diameter greater than saline negative control) to protein extracts of at least one of 9 common indoor allergens including dust mites, cockroach mix, rat, mouse, Alternaria, Cladosporium, Aspergillus, cat and dog tested at Visit 0 (or positive RAST test to at least on aeroallergen if FEV1<60% at Visit 0 precluding allergen skin testing.)
- Evidence of at least one allergen in household dust which matches skin test positivity or RAST testing (overlap to be checked and recorded at V3).
- Asthma confirmed by either reversibility to 4 puffs albuterol greater than or equal to 12% in FEV1 at V0 OR PC20 FEV1 methacholine of less than or equal 16 mg/ml at or up to 30 days previous to V1.
- Sleeps overnight at same address at least 5 times per week.
Who cannot join
- Significant medical illness other than asthma including other chronic respiratory illness (eg emphysema, cystic fibrosis)
- Currently receiving immunotherapy or received such therapy in the past year
- Emergency Department (ED) visit for asthma or steroid taper within the past 2 weeks (may be rescreened at a future date).
- Investigational drug within the past 30 days; anti-IgE therapy within past 6 months
- Active smoker or greater than 10 pack year history of asthma
- Asthma requiring mechanical ventilation within the past 5 years
- Significant occupational exposures as determined by principal investigator.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Columbia University Medical Center
New York, New York, 10032
Jacobi Medical Center
The Bronx, New York, 10461
About this study
Official title: Comparative Effectiveness of Environmental Intervention and Standard Care in Ability to Reduce Pharmacologic Therapy for Asthma
Exposure to household allergens is a major contributor to asthma symptoms. Aggressive measures to reduce household allergens has the potential to reduce asthma symptoms and the need for medications to control asthma. The investigators plan to enroll patients aged 6 and above into a single blind, randomized study comparing intensive environmental intervention with usual asthma care over a 48 week study period. All subjects will have asthma treatment optimized according to guideline based care. Subjects will be randomized to an aggressive environmental remediation arm versus distribution of written materials regarding allergen reduction ("usual care"). Primary outcome measure will be ability to reduce asthma step therapy. Secondary outcomes include measures of lung function, asthma biomarkers and quality of life.
Read the detailed description
Research question(s):
In individuals with atopic asthma who are being treated with inhaled corticosteroids with or without long acting beta agonists (1 of 6 possible steps of treatment), aggressive environmental intervention to reduce exposure to home allergens is more likely to lead to one step reduction in asthma controller therapy, improved asthma control and improved biomarkers of airway inflammation than is usual care.
Scientific abstract:
Environmental exposure to indoor allergens is a major contributor to asthma impairment and risk, particularly among asthmatic patients residing in inner cities. The investigators plan a randomized controlled trial to assess the effect of individualized, comprehensive, multifaceted indoor allergen avoidance measures on ability to step down asthma controller therapy in adults and children greater than 6 years with mild to severe persistent asthma.
Specifically,
- To determine via a randomized, controlled trial in allergen sensitized asthma patients whether environmental intervention aimed at reducing exposure to indoor allergens and irritants is more effective in reducing National Asthma Education and Prevention Program (NAEPP) step based therapy than usual care over a 48 week study period.
2a. To determine if environmental intervention leads to reduction in indoor allergen levels, allergen specific serum IgE levels, airway hyper-responsiveness, fractional excretion of nitric oxide, asthma symptom score, asthma exacerbations, treatment failures and improved lung function compared to usual care over a 48 week study period.
2b. (Exploratory): To determine if there is an association between reduction in allergen specific IgE level and reduction in NAEPP step level required for asthma control among subjects randomized to environmental intervention compared with usual care.
- Conditions
- Asthma
- Being tested
- Environmental Intervention
- Keywords
- Allergies, Asthma, Environmental, NYC, Manhattan, Harlem, Bronx, Brooklyn, Breathing, eNO, IgE, Allergens, Cockroach, Dust mites, Pets
- Medical subject headings
- Asthma, Hypersensitivity, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Environmental InterventionOther
Home-based environmental intervention
| Study group | Role | What they receive |
|---|---|---|
| Environmental Intervention | Experimental | If randomized to this part of the study the patient will receive an individualized homebased program. In addition to general handouts provided to at Visit 3, subjects in this arm will also receive home-based education by Intervention Counselors about how indoor allergens can affect asthma and the importance of strategies for removing allergens. The goal of the intervention is to provide the patient with the knowledge and skills necessary to remove allergens from their home, and to assist them with those clean up measures. Some of the measures implemented will be specifically based on data we have previously collected from them in the clinic and from their previous home visit, while others will be general to reduce all allergen level. Receives: Other: Environmental Intervention |
| Control Group | No intervention | If assigned to this group the patient will receive general health/safety related counseling. At the counselor visit following randomization, the patient will receive handouts related to general health and safety issues. They will also have visits by the Home Evaluators for assessment of the home and collection of dust samples identical to those in the treatment group (week 28 and week 44). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Step down of medication
Based on subject's lung function and symptoms
Measured: V4-V7 (every two months)
Secondary outcomes (6)
Change in allergen specific serum IgE levels
Blood test
Measured: Visit 3, Visit 5 and Visit 8 (approximately every 4 months)
Change in airway hyper-responsiveness
As determined by Methacholine Challenge
Measured: Visit 1 and Visit 7 (initial visit and at month 10)
Fractional excretion of nitric oxide
Measured by Aerocrine Mino
Measured: V3-V8 (every two months)
Asthma symptom score
Standardized questionnaire
Measured: V3-V8 (every two months)
Asthma exacerbations
Patient reported outcome
Measured: Every visit (every two weeks for two months, then every two months)
lung function
spirometry pulmonary function testing
Measured: Every visit (every month for two months, then every two months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2012 (estimated)
- Study startApr 2011
- Primary completionSep 2013
- Study completionSep 2013
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.
- More trials run by Columbia UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Responsible party
- Principal investigator, Emily DiMango, MD, Columbia University
- Investigators
- Emily DiMango, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01593111
- Sponsor's protocol ID
- AAAF3904
- Acronym
- ERA
- Status last verified
- Jan 2022
- First submitted
- 27 Feb 2012
- Last updated
- 4 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Environmental Intervention and Standard Care in Ability to Reduce Pharmacologic Therapy for Asthma
- ClinicalTrials.gov ID
- NCT01593111
- Acronym / sponsor ID
- ERA / AAAF3904
- Conditions
- Asthma
- Keywords
- Allergies, Asthma, Environmental, NYC, Manhattan, Harlem, Bronx, Brooklyn
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ)
- Study start
- Apr 2011
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 7 May 2012 (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.
Exposure to household allergens is a major contributor to asthma symptoms. Aggressive measures to reduce household allergens has the potential to reduce asthma symptoms and the need for medications to control asthma. The investigators plan to enroll patients aged 6 and above into a single blind, randomized study comparing intensive environmental intervention with usual asthma care over a 48 week study period. All subjects will have asthma treatment optimized according to guideline based care. Subjects will be randomized to an aggressive environmental remediation arm versus distribution of written materials regarding allergen reduction ("usual care"). Primary outcome measure will be ability to reduce asthma step therapy. Secondary outcomes include measures of lung function, asthma biomarkers and quality of life.
Detailed description
Research question(s):
In individuals with atopic asthma who are being treated with inhaled corticosteroids with or without long acting beta agonists (1 of 6 possible steps of treatment), aggressive environmental intervention to reduce exposure to home allergens is more likely to lead to one step reduction in asthma controller therapy, improved asthma control and improved biomarkers of airway inflammation than is usual care.
Scientific abstract:
Environmental exposure to indoor allergens is a major contributor to asthma impairment and risk, particularly among asthmatic patients residing in inner cities. The investigators plan a randomized controlled trial to assess the effect of individualized, comprehensive, multifaceted indoor allergen avoidance measures on ability to step down asthma controller therapy in adults and children greater than 6 years with mild to severe persistent asthma.
Specifically,
- To determine via a randomized, controlled trial in allergen sensitized asthma patients whether environmental intervention aimed at reducing exposure to indoor allergens and irritants is more effective in reducing National Asthma Education and Prevention Program (NAEPP) step based therapy than usual care over a 48 week study period.
2a. To determine if environmental intervention leads to reduction in indoor allergen levels, allergen specific serum IgE levels, airway hyper-responsiveness, fractional excretion of nitric oxide, asthma symptom score, asthma exacerbations, treatment failures and improved lung function compared to usual care over a 48 week study period.
2b. (Exploratory): To determine if there is an association between reduction in allergen specific IgE level and reduction in NAEPP step level required for asthma control among subjects randomized to environmental intervention compared with usual care.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Environmental Intervention | Experimental | Other: Environmental InterventionIf randomized to this part of the study the patient will receive an individualized homebased program. In addition to general handouts provided to at Visit 3, subjects in this arm will also receive home-based education by Intervention Counselors about how indoor allergens can affect asthma and the importance of strategies for removing allergens. The goal of the intervention is to provide the patient with the knowledge and skills necessary to remove allergens from their home, and to assist them with those clean up measures. Some of the measures implemented will be specifically based on data we have previously collected from them in the clinic and from their previous home visit, while others will be general to reduce all allergen level. |
| Control Group | No intervention | –If assigned to this group the patient will receive general health/safety related counseling. At the counselor visit following randomization, the patient will receive handouts related to general health and safety issues. They will also have visits by the Home Evaluators for assessment of the home and collection of dust samples identical to those in the treatment group (week 28 and week 44). |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical history consistent with asthma in male and female subjects ages 6 and above.
- Need for controller therapy demonstrated by current use of a stable dose (at least 4 weeks) of long term asthma controller therapy; or if not receiving long term asthma controller, symptoms consistent with persistent asthma (eg. Symptoms > 3x per week).
- Prebronchodilator FEV1 > 40% predicted at screening (V0)
- Positive skin test (defined as wheal greater than 3 mm in diameter greater than saline negative control) to protein extracts of at least one of 9 common indoor allergens including dust mites, cockroach mix, rat, mouse, Alternaria, Cladosporium, Aspergillus, cat and dog tested at Visit 0 (or positive RAST test to at least on aeroallergen if FEV1<60% at Visit 0 precluding allergen skin testing.)
- Evidence of at least one allergen in household dust which matches skin test positivity or RAST testing (overlap to be checked and recorded at V3).
Key exclusion criteria (7 listed)
- Significant medical illness other than asthma including other chronic respiratory illness (eg emphysema, cystic fibrosis)
- Currently receiving immunotherapy or received such therapy in the past year
- Emergency Department (ED) visit for asthma or steroid taper within the past 2 weeks (may be rescreened at a future date).
- Investigational drug within the past 30 days; anti-IgE therapy within past 6 months
- Active smoker or greater than 10 pack year history of asthma
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 |
|---|---|---|
| Environmental InterventionHome-based environmental intervention | Other | Environmental Intervention |
Primary outcome
Step down of medication
Time frame: V4-V7 (every two months)
Based on subject's lung function and symptoms
6 secondary outcomes
Change in allergen specific serum IgE levels
Time frame: Visit 3, Visit 5 and Visit 8 (approximately every 4 months)
Change in airway hyper-responsiveness
Time frame: Visit 1 and Visit 7 (initial visit and at month 10)
Fractional excretion of nitric oxide
Time frame: V3-V8 (every two months)
Asthma symptom score
Time frame: V3-V8 (every two months)
Asthma exacerbations
Time frame: Every visit (every two weeks for two months, then every two months)
lung function
Time frame: Every visit (every month for two months, then every two 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 4 Feb 2022.
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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.
Emily DiMango, MD principal investigator
Columbia University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Environmental Intervention in people with Asthma, run by Columbia University at 2 sites 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?
The sponsor lists 7 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 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does the primary outcome measure?
Step down of medication (time frame: V4-V7 (every two 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 4 Feb 2022.