Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00394329
Status:
COMPLETED
Last Update Posted:
2018-07-02
First Post:
2006-10-30
Brief Title:
CARE Network Trial - Treating Children to Prevent Exacerbations of Asthma TREXA
Sponsor:
Milton S Hershey Medical Center
Organization:
Milton S Hershey Medical Center
Study Overview
Official Title:
Childhood Asthma Research and Education CARE Network Trial - Treating Children to Prevent Exacerbations of Asthma TREXA
Status:
COMPLETED
Status Verified Date:
2018-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TREXA
Brief Summary:
Asthma is a common serious illness among children in the United States It can be effectively controlled through the use of preventative medications and rescue medications which are used to control symptoms This study will evaluate the impact and severity of asthma exacerbations that occur in children with mild persistent asthma who are receiving various combinations of medications for daily and rescue use
Detailed Description:
Almost 9 million children in the United States have asthma and it is a leading cause of hospitalizations and school absenteeism Common asthma symptoms include wheezing shortness of breath chest tightness and coughing While there is no cure for asthma most children who receive proper treatment are able to control symptoms and lead a normal life Asthma is commonly treated with two types of medications long-term control medication such as inhaled corticosteroids ICS which is taken on a regular schedule to prevent symptoms and keep asthma under control and quick-relief or rescue medication such as albuterol which is used on an as-needed-basis with the onset of symptoms or an asthma attack The purpose of this study is to assess the impact and severity of asthma exacerbations that occur in children with mild persistent asthma who are receiving ICS on a daily basis plus ICS and albuterol as rescue medications
This study will begin with a 4-week screening period during which participants will be monitored while they use an inhaler with a low dose of ICS medication Study visits will occur at study entry and Week 4 Participants will undergo a physical examination lung function and airway pressure testing and blood collection At the Week 4 study visit participants will be randomly assigned to one of the following four groups for 44 weeks of treatment
Group 1 will take ICS twice a day and ICS plus albuterol as rescue medication
Group 2 will take ICS twice a day and placebo ICS plus albuterol as rescue medication
Group 3 will take placebo ICS twice a day and ICS plus albuterol as rescue medication
Group 4 will take placebo ICS twice a day and placebo ICS plus albuterol as rescue medication
Each participant will receive three inhalers with their assigned medication One inhaler will be used twice daily throughout the study The other two inhalers will be used consecutively on an as-needed-basis as rescue medication Study visits will occur at Weeks 8 16 24 32 40 and 48 A physical examination blood collection and lung function and airway pressure testing will occur at selected visits Questionnaires to assess quality of life and asthma control will also be completed A methacholine challenge test will be completed at some study visits This test artificially triggers an asthma attack to determine the severity of an individuals asthma Throughout the study participants will record asthma symptoms and rescue medication usage in a daily diary
This study will begin with a 4-week screening period during which participants will be monitored while they use an inhaler with a low dose of ICS medication Study visits will occur at study entry and Week 4 Participants will undergo a physical examination lung function and airway pressure testing and blood collection At the Week 4 study visit participants will be randomly assigned to one of the following four groups for 44 weeks of treatment
Group 1 will take ICS twice a day and ICS plus albuterol as rescue medication
Group 2 will take ICS twice a day and placebo ICS plus albuterol as rescue medication
Group 3 will take placebo ICS twice a day and ICS plus albuterol as rescue medication
Group 4 will take placebo ICS twice a day and placebo ICS plus albuterol as rescue medication
Each participant will receive three inhalers with their assigned medication One inhaler will be used twice daily throughout the study The other two inhalers will be used consecutively on an as-needed-basis as rescue medication Study visits will occur at Weeks 8 16 24 32 40 and 48 A physical examination blood collection and lung function and airway pressure testing will occur at selected visits Questionnaires to assess quality of life and asthma control will also be completed A methacholine challenge test will be completed at some study visits This test artificially triggers an asthma attack to determine the severity of an individuals asthma Throughout the study participants will record asthma symptoms and rescue medication usage in a daily diary
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 5U10HL064307 | NIH | None | httpsreporternihgovquickSearch5U10HL064307 |
| 5U10HL064313 | NIH | None | None |
| 5U10HL064288 | NIH | None | None |
| 5U10HL064305 | NIH | None | None |
| 5U10HL064295 | NIH | None | None |
| 5U10HL064287 | NIH | None | None |