Asthma
Conditions
Brief 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. 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.
Interventions
DRUGFlovent Diskus
Inhaled corticosteroids
OTHERHome Environmental Intervention
Mouse, Cockroach, Furry pets, Dust mites, Smoking, air purifiers, laundered bedding
DRUGAdvair Diskus
inhaled corticosteroids + long-acting beta agonist
Sponsors
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
5 Years to 17 Years
Healthy volunteers
No
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: 1. On a long-term controller medication for asthma, or 2. 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 * Have evidence of uncontrolled disease as defined by at least one of the following: 1. One asthma-related unscheduled visit to an emergency department (ED), clinic or urgent care facility in the previous 12 mo 2. One asthma-related overnight hospitalization in the previous 12 mo 3. 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)
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Medication Treatment Step Assigned | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Daily Inhaled Corticosteroid Dose | 6 months | micrograms of inhaled corticosteroids (daily) |
| Exhaled Nitric Oxide | 6 months | Exhaled nitric oxide in parts per billion. |
| Number of Asthma Symptom Days | 6 months | Number of asthma symptom days in the past two weeks will be a measure of asthma control. |
| Number of Asthma Exacerbations | 6 months | Asthma exacerbations will be assessed by number of acute visits to the emergency department (ED), hospitalizations and urgent doctor visits. |
| FEV1/FVC | 6 months | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 77 |
| 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 | 78 |
| Total | 155 |
Baseline characteristics
| Characteristic | ECS + Medication Group | Total | Medication Group Alone |
|---|---|---|---|
| Age, Continuous | 10.1 years STANDARD_DEVIATION 3.3 | 10.1 years STANDARD_DEVIATION 3.3 | 10.1 years STANDARD_DEVIATION 3.3 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 4 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 75 Participants | 151 Participants | 76 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 72 Participants | 139 Participants | 67 Participants |
| Race (NIH/OMB) More than one race | 4 Participants | 12 Participants | 8 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 1 Participants | 4 Participants | 3 Participants |
| Region of Enrollment United States | 77 Participants | 155 Participants | 78 Participants |
| Sex: Female, Male Female | 31 Participants | 61 Participants | 30 Participants |
| Sex: Female, Male Male | 46 Participants | 94 Participants | 48 Participants |
| The treatment step assigned | 4.34 score on a scale STANDARD_DEVIATION 1.56 | 4.45 score on a scale STANDARD_DEVIATION 1.56 | 4.56 score on a scale STANDARD_DEVIATION 1.57 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 77 | 0 / 78 |
| other Total, other adverse events | 0 / 77 | 0 / 78 |
| serious Total, serious adverse events | 2 / 77 | 10 / 78 |
Outcome results
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.
Time frame: 6 month clinic visit
Population: participants completing the final 6 month follow-up visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ECS + Medication Group | The Medication Treatment Step Assigned | 4.03 score on a scale | Standard Deviation 1.91 |
| Medication Group Alone | The Medication Treatment Step Assigned | 4.05 score on a scale | Standard Deviation 1.87 |
Secondary
Daily Inhaled Corticosteroid Dose
micrograms of inhaled corticosteroids (daily)
Time frame: 6 months
Population: participants who completed the final follow-up visit at 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ECS + Medication Group | Daily Inhaled Corticosteroid Dose | 557.5 micrograms/day | Standard Deviation 347.8 |
| Medication Group Alone | Daily Inhaled Corticosteroid Dose | 527.7 micrograms/day | Standard Deviation 401.7 |
Secondary
Exhaled Nitric Oxide
Exhaled nitric oxide in parts per billion.
Time frame: 6 months
Population: participants completing the final follow-up visit at 6 months with valid exhaled nitric oxide measurement. Not all participants had valid measures.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| ECS + Medication Group | Exhaled Nitric Oxide | 20 parts per billion |
| Medication Group Alone | Exhaled Nitric Oxide | 20 parts per billion |
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.
Time frame: 6 months
Population: participants completing the 6 month follow-up visit
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ECS + Medication Group | FEV1/FVC | 79.3 ratio | Standard Deviation 8.1 |
| Medication Group Alone | FEV1/FVC | 80.8 ratio | Standard Deviation 8.8 |
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.
Time frame: 6 months
Population: participants completing the 6 month follow-up visit
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| ECS + Medication Group | Number of Asthma Exacerbations | 35 acute visits |
| Medication Group Alone | Number of Asthma Exacerbations | 53 acute visits |
Secondary
Number of Asthma Symptom Days
Number of asthma symptom days in the past two weeks will be a measure of asthma control.
Time frame: 6 months
Population: participants who completed the final follow-up visit at 6 months.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ECS + Medication Group | Number of Asthma Symptom Days | 2.5 days | Standard Deviation 3.2 |
| Medication Group Alone | Number of Asthma Symptom Days | 2.7 days | Standard Deviation 3.6 |