AsthmaNCT00294398
Inhaled Corticosteroids After a Pediatric Emergency Visit for Asthma
A study testing ICS Prescription + Standard Asthma ED Discharge Therapy and Standard Asthma ED Discharge Therapy in people with Asthma, run by Children's Hospital of Philadelphia at 1 site in United States.
Trial summary
Specific Aim: To determine whether a prescription for Inhaled Corticosteroids (ICS) added to standard Emergency Department (ED) discharge therapy for young children with persistent asthma symptoms increases ICS use and improves symptoms and quality of life over the months following the ED visit. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Asthma
- What is being tested?
- ICS Prescription + Standard Asthma ED Discharge Therapy and Standard Asthma ED Discharge Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 152 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2006to Nov 2009
- Phase
- Interventional
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 12 months through 18 years
- History of asthma defined as 2 or more prior physician visits at which bronchodilators were prescribed
- Persistent symptoms identified by an asthma control tool based on the NAEPP Guidelines and developed and validated by a multidisciplinary team of clinicians from CHOP Allergy, Pulmonary Medicine, General Pediatrics and Emergency Medicine.
- Treated in ED for acute asthma with plan to discharge from the ED on oral prednisone
- Have a Primary Care Physician (PCP)
Who cannot join
- Current hospitalization or admission to the extended day emergency care unit
- History of pediatric intensive care admission for asthma
- Current prescription for a controller medication such as inhaled corticosteroids (ICS), leukotriene receptor antagonists, or cromolyn
- Contraindications to the use of routine asthma medications including beta-agonists or systemic steroids
- Co-morbid disease: Chronic lung disease, for example cystic fibrosis; Congenital heart disease requiring surgery and/or medications; Sickle cell disease; Immunodeficiency syndromes
- Previous enrollment in the study
Trial locations and contacts
1 site in 1 country.
About this study
Specific Aim:
To determine whether a prescription for Inhaled Corticosteroids (ICS) added to standard Emergency Department (ED) discharge therapy for young children with persistent asthma symptoms increases ICS use and improves symptoms and quality of life over the months following the ED visit.
Read more
Hypotheses:
In a cohort of pediatric patients with persistent asthma discharged from the ED after an acute asthma exacerbation, a prescription for ICS will:
- Improve usage of ICS as measured by refill of a prescription within the first 2 months after the ED visit
- Improve symptom severity at two weeks after an ED visit as measured by days of cough, wheeze, missed school, daycare or work
- Improve patient and caregiver asthma-related quality of life during the 2 months following an ED visit measured by asthma Health Related Quality of Life (HRQL)
- Improve asthma control at 2 months as measured by a validated asthma instrument
Read the detailed description
Abstract.
Background: Asthma prevalence, emergency visits, and hospitalizations have increased substantially, especially among young children and urban populations. Although inhaled corticosteroids (ICS) are the mainstay of treatment for persistent asthma, studies have demonstrated a low rate of ICS usage and primary care provider follow-up within a month of an Emergency Department (ED) visit. Furthermore, ICS usage and adherence with National Asthma Education and Prevention Program (NAEPP) recommendations is low even for children that follow-up with their primary care physician (PCP). In addition, other studies have demonstrated frequent symptoms, activity restriction, and missed school or work during the weeks following an ED visit. Prescribing ICS at ED discharge occurs uncommonly in the United States based on surveys and reviews of current practice. Adult studies have been inconclusive and the role of ICS after a pediatric emergency visit for asthma has not been studied. This study will assess the short-term outcomes of prescribing ICS to young children with persistent asthma symptoms after an emergency visit for asthma.
Objective: To determine whether a prescription for ICS added to standard asthma ED discharge therapy to young children with persistent asthma increases adherence to NAEPP guidelines for ICS usage at 2 months follow up and improves short-term symptoms and quality of life for patient and caregiver.
Methods: Randomized control trial of children 1- 8yo of age with persistent asthma being discharged after an emergency visit for asthma. Subjects will be randomized to receive standard therapy of oral corticosteroid, albuterol, and education versus standard care plus a prescription for budesonide once daily. A questionnaire will be administered at baseline, with follow-up telephone interviews conducted at 2 weeks and 2 months. Pharmacy verification of refill of a second prescription of ICS will be the primary outcome. Asthma symptoms and quality of life will be assessed as secondary outcomes.
- Conditions
- Asthma
- Being tested
- ICS Prescription + Standard Asthma ED Discharge Therapy, Standard Asthma ED Discharge Therapy
- Keywords
- Asthma, Controller Medications
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICS Prescription + Standard Asthma ED Discharge TherapyOther
Also called Budesonide, Fluticasone propionate, Pulmicort, Flovent
Subjects are given a prescription for a 30 day supply of an inhaled corticosteroid based on age:
1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily
Standard Asthma ED Discharge TherapyOther
Also called Control
Subjects are instructed to use albuterol as needed (up to every 4 hours), may be prescribed prednisone and to follow-up with their primary doctor in 3-5 days. All view an educational video about asthma control and are provided a home nebulizer if needed.
| Study group | Role | What they receive |
|---|---|---|
| Standard Asthma ED Discharge Therapy | Other | Standard asthma therapy including oral corticosteroids, albuterol, education and discharge instructions. Receives: Other: Standard Asthma ED Discharge Therapy |
| ICS Prescription + Standard Asthma ED Discharge Therapy | Experimental | Subjects are given a prescription for a 30 day supply of an inhaled corticosteroid based on age:
1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily Receives: Other: ICS Prescription + Standard Asthma ED Discharge Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Inhaled Corticosteroid (ICS) Prescriptions Refilled (Confirmed by Primary Care Physician)
Verification of a filled prescription for an ICS was completed 2 months after emergency department (ED) visit via telephone call to the pharmacy. Individual informed consent forms were faxed to the pharmacy to obtain verification that a prescription was filled. The number of subjects who filled a prescription for an ICS after the ED visit was compared between the two groups.
Measured: 2 months
Secondary outcomes (1)
Asthma-related Quality of Life
Bukstein health-related quality of life instrument is an an 8-item questionnaire for measuring health-related quality of life in pediatric asthma. The daytime and nighttime symptom scales for each contain 2 items and the functional limitations scale 4 items. Prior validation studies confirm each scale's ability to detect changes at both low and high levels of functioning. The scale is scored from 0 to 100, with higher scores indicating better quality of life and lower scores translate to poorer health-related quality of life.
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2006 (estimated)
- Study startMar 2006
- Primary completionNov 2009
- Study completionNov 2009
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.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Children's Hospital of PhiladelphiaThe 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
- None (open label)
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Philadelphia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Esther M Sampayo, MD, Principal investigator, CHOP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00294398
- Sponsor's protocol ID
- 2005-8-4458
- Status last verified
- Apr 2015
- First submitted
- 20 Feb 2006
- Last updated
- 13 May 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Bukstein DA, McGrath MM, Buchner DA, Landgraf J, Goss TF. Evaluation of a short form for measuring health-related quality of life among pediatric asthma patients. J Allergy Clin Immunol. 2000 Feb;105(2 Pt 1):245-51. doi: 10.1016/s0091-6749(00)90072-1.
PubMed 10669843Zorc JJ, Pawlowski NA, Allen JL, Bryant-Stephens T, Winston M, Angsuco C, Shea JA. Development and validation of an instrument to measure asthma symptom control in children. J Asthma. 2006 Dec;43(10):753-8. doi: 10.1080/02770900601031615.
PubMed 17169827
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Corticosteroids After a Pediatric Emergency Visit for Asthma
- ClinicalTrials.gov ID
- NCT00294398
- Acronym / sponsor ID
- 2005-8-4458
- Conditions
- Asthma
- Keywords
- Asthma, Controller Medications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Children's Hospital of PhiladelphiaUniversity, hospital or other
- Study start
- Mar 2006
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 22 Feb 2006 (estimated)
- Results
- Posted 24 Apr 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Specific Aim:
To determine whether a prescription for Inhaled Corticosteroids (ICS) added to standard Emergency Department (ED) discharge therapy for young children with persistent asthma symptoms increases ICS use and improves symptoms and quality of life over the months following the ED visit.
Hypotheses:
In a cohort of pediatric patients with persistent asthma discharged from the ED after an acute asthma exacerbation, a prescription for ICS will:
- Improve usage of ICS as measured by refill of a prescription within the first 2 months after the ED visit
- Improve symptom severity at two weeks after an ED visit as measured by days of cough, wheeze, missed school, daycare or work
- Improve patient and caregiver asthma-related quality of life during the 2 months following an ED visit measured by asthma Health Related Quality of Life (HRQL)
- Improve asthma control at 2 months as measured by a validated asthma instrument
Detailed description
Abstract.
Background: Asthma prevalence, emergency visits, and hospitalizations have increased substantially, especially among young children and urban populations. Although inhaled corticosteroids (ICS) are the mainstay of treatment for persistent asthma, studies have demonstrated a low rate of ICS usage and primary care provider follow-up within a month of an Emergency Department (ED) visit. Furthermore, ICS usage and adherence with National Asthma Education and Prevention Program (NAEPP) recommendations is low even for children that follow-up with their primary care physician (PCP). In addition, other studies have demonstrated frequent symptoms, activity restriction, and missed school or work during the weeks following an ED visit. Prescribing ICS at ED discharge occurs uncommonly in the United States based on surveys and reviews of current practice. Adult studies have been inconclusive and the role of ICS after a pediatric emergency visit for asthma has not been studied. This study will assess the short-term outcomes of prescribing ICS to young children with persistent asthma symptoms after an emergency visit for asthma.
Objective: To determine whether a prescription for ICS added to standard asthma ED discharge therapy to young children with persistent asthma increases adherence to NAEPP guidelines for ICS usage at 2 months follow up and improves short-term symptoms and quality of life for patient and caregiver.
Methods: Randomized control trial of children 1- 8yo of age with persistent asthma being discharged after an emergency visit for asthma. Subjects will be randomized to receive standard therapy of oral corticosteroid, albuterol, and education versus standard care plus a prescription for budesonide once daily. A questionnaire will be administered at baseline, with follow-up telephone interviews conducted at 2 weeks and 2 months. Pharmacy verification of refill of a second prescription of ICS will be the primary outcome. Asthma symptoms and quality of life will be assessed as secondary outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Asthma ED Discharge Therapy | Other | Other: Standard Asthma ED Discharge TherapyStandard asthma therapy including oral corticosteroids, albuterol, education and discharge instructions. |
| ICS Prescription + Standard Asthma ED Discharge Therapy | Experimental | Other: ICS Prescription + Standard Asthma ED Discharge TherapySubjects are given a prescription for a 30 day supply of an inhaled corticosteroid based on age: 1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 12 months through 18 years
- History of asthma defined as 2 or more prior physician visits at which bronchodilators were prescribed
- Persistent symptoms identified by an asthma control tool based on the NAEPP Guidelines and developed and validated by a multidisciplinary team of clinicians from CHOP Allergy, Pulmonary Medicine, General Pediatrics and Emergency Medicine.
- Treated in ED for acute asthma with plan to discharge from the ED on oral prednisone
- Have a Primary Care Physician (PCP)
Key exclusion criteria (6 listed)
- Current hospitalization or admission to the extended day emergency care unit
- History of pediatric intensive care admission for asthma
- Current prescription for a controller medication such as inhaled corticosteroids (ICS), leukotriene receptor antagonists, or cromolyn
- Contraindications to the use of routine asthma medications including beta-agonists or systemic steroids
- Co-morbid disease: Chronic lung disease, for example cystic fibrosis; Congenital heart disease requiring surgery and/or medications; Sickle cell disease; Immunodeficiency syndromes
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 |
|---|---|---|
| ICS Prescription + Standard Asthma ED Discharge TherapyAlso: Budesonide, Fluticasone propionate, Pulmicort, FloventSubjects are given a prescription for a 30 day supply of an inhaled corticosteroid based on age: 1-4 year olds Budesonide 0.5mg via nebulizer once daily; 5-11 year olds Fluticasone propionate 44mcg 2 puffs via spacer twice daily; 12-18 year olds Fluticasone propionate 110mcg 2 puffs via spacer twice daily | Other | ICS Prescription + Standard Asthma ED Discharge Therapy |
| Standard Asthma ED Discharge TherapyAlso: ControlSubjects are instructed to use albuterol as needed (up to every 4 hours), may be prescribed prednisone and to follow-up with their primary doctor in 3-5 days. All view an educational video about asthma control and are provided a home nebulizer if needed. | Other | Standard Asthma ED Discharge Therapy |
Primary outcome
Number of Inhaled Corticosteroid (ICS) Prescriptions Refilled (Confirmed by Primary Care Physician)
Time frame: 2 months
Verification of a filled prescription for an ICS was completed 2 months after emergency department (ED) visit via telephone call to the pharmacy. Individual informed consent forms were faxed to the pharmacy to obtain verification that a prescription was filled. The number of subjects who filled a prescription for an ICS after the ED visit was compared between the two groups.
1 secondary outcome
Asthma-related Quality of Life
Time frame: 2 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 10669843Bukstein DA, McGrath MM, Buchner DA, Landgraf J, Goss TF. Evaluation of a short form for measuring health-related quality of life among pediatric asthma patients. J Allergy Clin Immunol. 2000 Feb;105(2 Pt 1):245-51. doi: 10.1016/s0091-6749(00)90072-1.
- Background: PubMed 17169827Zorc JJ, Pawlowski NA, Allen JL, Bryant-Stephens T, Winston M, Angsuco C, Shea JA. Development and validation of an instrument to measure asthma symptom control in children. J Asthma. 2006 Dec;43(10):753-8. doi: 10.1080/02770900601031615.
Related trials for Asthma
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 1
A Study to Compare the Relative Potency of Salbutamol Administered Via Metered Dose Inhalers (MDI) Containing Propellants HFA-152a to HFA-134a in Mild Asthmatics Aged 18 to 65 Inclusive
Asthma, Mild Asthma
RecruitingPhase 3
A Study Assessing the Effect of Dupilumab on Inducing Clinical Remission in Asthma
Asthma Control
Active, not recruitingPhase 2/3
Local Antibiotic Delivery for Community Acquired Pneumonia
Community Acquired Pneumonia (CAP)
RecruitingPhase 2
A Study to Learn About the Study Medicine Called PF-07275315 in People With Moderate-To-Severe Asthma
Asthma
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.
Esther M Sampayo, MD principal investigator
CHOP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICS Prescription + Standard Asthma ED Discharge Therapy and Standard Asthma ED Discharge Therapy in people with Asthma, run by Children's Hospital of Philadelphia 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 5 inclusion and 6 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 13 May 2015. 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?
Yes. Results are posted in the registry (first posted 24 Apr 2015). 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?
Number of Inhaled Corticosteroid (ICS) Prescriptions Refilled (Confirmed by Primary Care Physician) (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00294398, which also lists 2 linked publications.
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 13 May 2015.