Ignite Creation Date:
2024-05-05 @ 5:02 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00377572
Status:
COMPLETED
Last Update Posted:
2017-03-21
First Post:
2006-09-14
Brief Title:
Inner-City Anti-IgE Therapy for Asthma
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Inner-City Anti-IgE Therapy for Asthma ICAC-08
Status:
COMPLETED
Status Verified Date:
2017-02
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:
ICATA
Brief Summary:
The purpose of this study is to find out if adding omalizumab to standard asthma treatment results in a safer more effective and longer lasting asthma treatment strategy than standard treatment alone in inner-city children with mild to severe asthma
Detailed Description:
This study is testing a medication called omalizumab for the treatment of asthma Immunoglobulin E IgE is produced when one is exposed to allergens and it can cause inflammation in the lungs Omalizumab can reduce inflammation and asthma attacks by blocking IgE Unlike other medications for asthma omalizumab is not an inhaler medication or pill Instead omalizumab is dissolved in a liquid and given by injection
Studies indicate that people living in the inner-city areas are more likely to be exposed to indoor allergens that are difficult to avoid than people living in other areas The purpose of this study is to find out if adding omalizumab to standard asthma treatment results in a safer more effective and longer lasting asthma treatment strategy than standard treatment alone
This study will recruit inner-city children and adolescents with moderate to severe allergic asthma This study will last about 15 to 2 years Participants will be randomly assigned to receive either omalizumab or placebo injections once every 2 or 4 weeks The injection schedule will be determined based on the participants weight and total IgE Both groups will receive standardized specialist care and basic asthma education including environmental control measures Participants must have some form of health care insurance to cover the costs of asthma controller medications prescribed during the study
Participants will complete a series of questionnaires about topics including perceived stress home environment physical activity diet and nutrition smoking habits and quality of life At study entry and monthly throughout the study participants will complete questionnaires about their asthma symptoms and medical resource utilization Some visits will include a physical examination vital signs measurement lung function tests asthma medication evaluation and an asthma action plan Blood collection is required up to eight times during the study for safety labs
Studies indicate that people living in the inner-city areas are more likely to be exposed to indoor allergens that are difficult to avoid than people living in other areas The purpose of this study is to find out if adding omalizumab to standard asthma treatment results in a safer more effective and longer lasting asthma treatment strategy than standard treatment alone
This study will recruit inner-city children and adolescents with moderate to severe allergic asthma This study will last about 15 to 2 years Participants will be randomly assigned to receive either omalizumab or placebo injections once every 2 or 4 weeks The injection schedule will be determined based on the participants weight and total IgE Both groups will receive standardized specialist care and basic asthma education including environmental control measures Participants must have some form of health care insurance to cover the costs of asthma controller medications prescribed during the study
Participants will complete a series of questionnaires about topics including perceived stress home environment physical activity diet and nutrition smoking habits and quality of life At study entry and monthly throughout the study participants will complete questionnaires about their asthma symptoms and medical resource utilization Some visits will include a physical examination vital signs measurement lung function tests asthma medication evaluation and an asthma action plan Blood collection is required up to eight times during the study for safety labs
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 |
|---|---|---|---|
| ICATA | OTHER | NIAID | None |