AsthmaPhase 2ECATChNCT02251379
Environmental Control as Add-on Therapy in Childhood Asthma
A Phase 2 study testing Flovent Diskus, Home Environmental Intervention and Advair Diskus in people with Asthma, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study evaluates the effects of adding on an environmental home intervention to standard asthma medication management on controller medication requirements among children and adolescents with asthma. Read more about this study
- Who is it for?
- Ages 5 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- Flovent Diskus, Home Environmental Intervention and Advair Diskus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 155 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2014to Nov 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Have physician-diagnosed asthma at least 1 year prior to the baseline visit, or asthma symptoms for at least 1 year
- Meet criteria for current persistent asthma defined as either:
- On a long-term controller medication for asthma, or
- Meet National Asthma Education and Prevention Program (NAEPP) guideline requirements for persistent disease:(46)
- Asthma symptoms 3 or more days per week over the past 2 weeks or
- Nocturnal asthma symptoms at least 3 times in the past month
Show all 14Show fewer
- Have evidence of uncontrolled disease as defined by at least one of the following:
- One asthma-related unscheduled visit to an emergency department (ED), clinic or urgent care facility in the previous 12 mo
- One asthma-related overnight hospitalization in the previous 12 mo
- One or more bursts of oral corticosteroids in the previous 12 mo
- Reside within a geographic area of the study site so that home visits are feasible.
- Have no plans to move within the upcoming 6 months
- Have insurance to cover prescription medications.
- Have a positive skin test (net wheal ≥2mm) to cat, dog, mouse, cockroach, or dust mites or have a positive cat, dog, mouse, German cockroach, or D. farinae-specific immunoglobulin E (IgE) test, as quantified using the ImmunoCAP system (≥0.35 kU/L)
Who cannot join
- Lung disease, other than asthma, that requires daily medication
- Cardiovascular disease that requires daily medication, excluding hypertension
- Taking a beta-blocker
- Allergy to dairy
- On Xolair < 5 months
- On immunotherapy and has not reached maintenance dose
Show all 9Show fewer
- Sleeping in another home 4 or more nights/week
- Active smoker defined as a positive urine screen for high levels of urine cotinine
- Unable to access areas of home necessary to conduct extermination
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the effects of adding on an environmental home intervention to standard asthma medication management on controller medication requirements among children and adolescents with asthma. The investigators hypothesize that the addition of an individually-tailored, multi-faceted Environmental Control Strategy (ECS) to guidelines-based controller medication will result in less controller medication requirement and allergic inflammation than controller medication alone among urban asthmatic children.
Read the detailed description
The study is a parallel arm study of an individually tailored, multi-faceted ECS plus controller medication titration versus controller medication titration alone. After a 4-week run-in period to stabilize the asthma, the investigators will randomize 200 Baltimore children with persistent asthma and a recent exacerbation in a 1:1 ratio to the two arms and follow the children for six months. There will be five clinic visits and three home visits over this time period for clinical and home assessments, respectively. There will be up to four environmental intervention visits for participants randomized to the environmental control plus controller medication group. The environmental modules include mouse, cockroach, furry pets, dust mites, and smoking. Air purifiers and laundered bedding are also included in this arm. Participants randomized to the controller medication group have the option of having one home visit after completing the study at which the participants will receive home intervention services that the environmental control plus controller medication group received. Participants will have repeated assessment of: controller medication requirements; secondary clinical, physiologic, and inflammatory outcomes; and particulate matter (PM), air nicotine, and allergen levels.
- Conditions
- Asthma
- Being tested
- Flovent Diskus, Home Environmental Intervention, Advair Diskus
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flovent DiskusDrug
Also called Flovent Diskus, 50 mcg, 100mcg, 250 mcg
Inhaled corticosteroids
Home Environmental InterventionOther
Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding
Advair DiskusDrug
inhaled corticosteroids + long-acting beta agonist
| Study group | Role | What they receive |
|---|---|---|
| ECS + Medication Group | Experimental | The Environmental Control Strategy ("Home Environmental Intervention") plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus) Receives: Drug: Flovent Diskus; Other: Home Environmental Intervention; Drug: Advair Diskus |
| Medication Group Alone | Active comparator | inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus) Receives: Drug: Flovent Diskus; Drug: Advair Diskus |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Medication Treatment Step Assigned
The controller medication treatment step that was assigned at the visit, which is based on the current controller medication treatment step and the current level of asthma control. The range is from 0-6, with 0 indicating no controller medication and 6 indicating high dose inhaled corticosteroids plus long-acting beta agonist.
Measured: 6 month clinic visit
Secondary outcomes (5)
Daily Inhaled Corticosteroid Dose
micrograms of inhaled corticosteroids (daily)
Measured: 6 months
Exhaled Nitric Oxide
Exhaled nitric oxide in parts per billion.
Measured: 6 months
Number of Asthma Symptom Days
Number of asthma symptom days in the past two weeks will be a measure of asthma control.
Measured: 6 months
Number of Asthma Exacerbations
Asthma exacerbations will be assessed by number of acute visits to the emergency department (ED), hospitalizations and urgent doctor visits.
Measured: 6 months
FEV1/FVC
Forced expiratory volume at one second/forced vital capacity (FEV1/FVC) will be evaluated as a continuous variable. This is a ratio without any units.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2014 (estimated)
- Study start1 Oct 2014
- Primary completionNov 2018
- Study completionNov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 155 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Elizabeth C Matsui, MD MHS, Study chair, Johns Hopkins UniversityMeredith McCormack, MD MHS, Principal investigator, Johns Hopkins UniversityCorinne Keet, MD PHD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02251379
- Sponsor's protocol ID
- NA_00093323
- Acronym
- ECATCh
- Status last verified
- Nov 2019
- First submitted
- 22 Sep 2014
- Last updated
- 20 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Environmental Control as Add-on Therapy in Childhood Asthma
- ClinicalTrials.gov ID
- NCT02251379
- Acronym / sponsor ID
- ECATCh / NA_00093323
- Conditions
- Asthma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 155 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- Nov 2018 (actual)
- Study completion
- Nov 2018 (actual)
- First posted
- 29 Sep 2014 (estimated)
- Results
- Posted 4 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates the effects of adding on an environmental home intervention to standard asthma medication management on controller medication requirements among children and adolescents with asthma. The investigators hypothesize that the addition of an individually-tailored, multi-faceted Environmental Control Strategy (ECS) to guidelines-based controller medication will result in less controller medication requirement and allergic inflammation than controller medication alone among urban asthmatic children.
Detailed description
The study is a parallel arm study of an individually tailored, multi-faceted ECS plus controller medication titration versus controller medication titration alone. After a 4-week run-in period to stabilize the asthma, the investigators will randomize 200 Baltimore children with persistent asthma and a recent exacerbation in a 1:1 ratio to the two arms and follow the children for six months. There will be five clinic visits and three home visits over this time period for clinical and home assessments, respectively. There will be up to four environmental intervention visits for participants randomized to the environmental control plus controller medication group. The environmental modules include mouse, cockroach, furry pets, dust mites, and smoking. Air purifiers and laundered bedding are also included in this arm. Participants randomized to the controller medication group have the option of having one home visit after completing the study at which the participants will receive home intervention services that the environmental control plus controller medication group received. Participants will have repeated assessment of: controller medication requirements; secondary clinical, physiologic, and inflammatory outcomes; and particulate matter (PM), air nicotine, and allergen levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ECS + Medication Group | Experimental | Drug: Flovent Diskus, Other: Home Environmental Intervention, Drug: Advair DiskusThe Environmental Control Strategy ("Home Environmental Intervention") plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus) |
| Medication Group Alone | Active comparator | Drug: Flovent Diskus, Drug: Advair Diskusinhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus) |
Who may qualify
- Ages
- 5 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (14 listed)
- Have physician-diagnosed asthma at least 1 year prior to the baseline visit, or asthma symptoms for at least 1 year
- Meet criteria for current persistent asthma defined as either:
- Asthma symptoms 3 or more days per week over the past 2 weeks or
- Nocturnal asthma symptoms at least 3 times in the past month
- Have evidence of uncontrolled disease as defined by at least one of the following:
Key exclusion criteria (9 listed)
- Lung disease, other than asthma, that requires daily medication
- Cardiovascular disease that requires daily medication, excluding hypertension
- Taking a beta-blocker
- Allergy to dairy
- On Xolair < 5 months
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 |
|---|---|---|
| Flovent DiskusAlso: Flovent Diskus, 50 mcg, 100mcg, 250 mcgInhaled corticosteroids | Drug | ECS + Medication Group, Medication Group Alone |
| Home Environmental InterventionMouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding | Other | ECS + Medication Group |
| Advair Diskusinhaled corticosteroids + long-acting beta agonist | Drug | ECS + Medication Group, Medication Group Alone |
Primary outcome
The Medication Treatment Step Assigned
Time frame: 6 month clinic visit
The controller medication treatment step that was assigned at the visit, which is based on the current controller medication treatment step and the current level of asthma control. The range is from 0-6, with 0 indicating no controller medication and 6 indicating high dose inhaled corticosteroids plus long-acting beta agonist.
5 secondary outcomes
Daily Inhaled Corticosteroid Dose
Time frame: 6 months
Exhaled Nitric Oxide
Time frame: 6 months
Number of Asthma Symptom Days
Time frame: 6 months
Number of Asthma Exacerbations
Time frame: 6 months
FEV1/FVC
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Elizabeth C Matsui, MD MHS study chair
Johns Hopkins University
Meredith McCormack, MD MHS principal investigator
Johns Hopkins University
Corinne Keet, MD PHD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Flovent Diskus, Home Environmental Intervention and Advair Diskus in people with Asthma, run by Johns Hopkins University 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?
The sponsor lists 14 inclusion and 9 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 20 Nov 2019. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Medication Treatment Step Assigned (time frame: 6 month clinic visit). 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 20 Nov 2019.