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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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) |
|
| Medication Group Alone | Active Comparator | inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flovent Diskus | Drug | Inhaled corticosteroids |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 month clinic visit |
| Measure | Description | Time Frame |
|---|---|---|
| Daily Inhaled Corticosteroid Dose | micrograms of inhaled corticosteroids (daily) | 6 months |
| Exhaled Nitric Oxide | Exhaled nitric oxide in parts per billion. |
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Inclusion Criteria:
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:
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)
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth C Matsui, MD MHS | Johns Hopkins University | Study Chair |
| Meredith McCormack, MD MHS | Johns Hopkins University | Principal Investigator |
| Corinne Keet, MD PHD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | ECS + Medication Group | The Environmental Control Strategy ("Home Environmental Intervention") plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus) Flovent Diskus: Inhaled corticosteroids Home Environmental Intervention: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding Advair Diskus: inhaled corticosteroids + long-acting beta agonist |
| FG001 | Medication Group Alone | inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus) Flovent Diskus: Inhaled corticosteroids Advair Diskus: inhaled corticosteroids + long-acting beta agonist |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | ECS + Medication Group | The Environmental Control Strategy ("Home Environmental Intervention") plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus) Flovent Diskus: Inhaled corticosteroids Home Environmental Intervention: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding Advair Diskus: inhaled corticosteroids + long-acting beta agonist |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | participants completing the final 6 month follow-up visit | Posted | Mean | Standard Deviation | score on a scale | 6 month clinic visit |
|
During the enrollment period, approximately 7 months
Hospitalizations, including asthma-related hospitalizations, were considered serious adverse events. Participants were asked at each clinic visit about adverse events.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ECS + Medication Group | The Environmental Control Strategy ("Home Environmental Intervention") plus inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus) Flovent Diskus: Inhaled corticosteroids Home Environmental Intervention: Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding Advair Diskus: inhaled corticosteroids + long-acting beta agonist |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| asthma hospitalization | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Corinne Keet | Johns Hopkins University | 410-955-5883 | ckeet1@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 3, 2016 | Oct 14, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001249 | Asthma |
| ID | Term |
|---|---|
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
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| ID | Term |
|---|---|
| D000068298 | Fluticasone |
| D000068297 | Fluticasone-Salmeterol Drug Combination |
| ID | Term |
|---|---|
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
| D013256 | Steroids |
| D000072473 |
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| Home Environmental Intervention | Other | Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding |
|
| Advair Diskus | Drug | inhaled corticosteroids + long-acting beta agonist |
|
| 6 months |
| Number of Asthma Symptom Days | Number of asthma symptom days in the past two weeks will be a measure of asthma control. | 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. | 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. | 6 months |
| BG001 | Medication Group Alone | inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus) Flovent Diskus: Inhaled corticosteroids Advair Diskus: inhaled corticosteroids + long-acting beta agonist |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| The 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. | Mean | Standard Deviation | score on a scale |
|
| OG001 | Medication Group Alone | inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus) Flovent Diskus: Inhaled corticosteroids Advair Diskus: inhaled corticosteroids + long-acting beta agonist |
|
|
| Secondary | Daily Inhaled Corticosteroid Dose | micrograms of inhaled corticosteroids (daily) | participants who completed the final follow-up visit at 6 months | Posted | Mean | Standard Deviation | micrograms/day | 6 months |
|
|
|
| Secondary | Exhaled Nitric Oxide | Exhaled nitric oxide in parts per billion. | participants completing the final follow-up visit at 6 months with valid exhaled nitric oxide measurement. Not all participants had valid measures. | Posted | Median | Inter-Quartile Range | parts per billion | 6 months |
|
|
|
| Secondary | Number of Asthma Symptom Days | Number of asthma symptom days in the past two weeks will be a measure of asthma control. | participants who completed the final follow-up visit at 6 months. | Posted | Mean | Standard Deviation | days | 6 months |
|
|
|
| Secondary | Number of Asthma Exacerbations | Asthma exacerbations will be assessed by number of acute visits to the emergency department (ED), hospitalizations and urgent doctor visits. | participants completing the 6 month follow-up visit | Posted | Number | acute visits | 6 months |
|
|
|
| Secondary | 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. | participants completing the 6 month follow-up visit | Posted | Mean | Standard Deviation | ratio | 6 months |
|
|
|
| 0 |
| 77 |
| 2 |
| 77 |
| 0 |
| 77 |
| EG001 | Medication Group Alone | inhaled corticosteroids or inhaled corticosteroids plus long-acting beta agonist. (Flovent Diskus or Advair diskus) Flovent Diskus: Inhaled corticosteroids Advair Diskus: inhaled corticosteroids + long-acting beta agonist | 0 | 78 | 10 | 78 | 0 | 78 |
| hospitalization | Psychiatric disorders | Systematic Assessment |
|
| hospitalization | Gastrointestinal disorders | Systematic Assessment |
|
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| D012130 |
| Respiratory Hypersensitivity |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D000068299 | Salmeterol Xinafoate |
| D000420 | Albuterol |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |