Ignite Creation Date:
2024-05-05 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00179998
Status:
COMPLETED
Last Update Posted:
2019-05-09
First Post:
2005-09-10
Brief Title:
Effectiveness of Pulmozyme in Infants With Cystic Fibrosis
Sponsor:
Nationwide Childrens Hospital
Organization:
Nationwide Childrens Hospital
Study Overview
Official Title:
Efficacy of Pulmozyme in Infants and Young Children With Cystic Fibrosis
Status:
COMPLETED
Status Verified Date:
2019-04
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:
None
Brief Summary:
This is a study to find out whether Pulmozyme is effective for clearing mucus from the airways of children with cystic fibrosis less than 3 ½ years of age
Detailed Description:
Pulmozyme is given using a nebulizer and is now widely used in older children and adults with cystic fibrosis In adults and older children studies have shown that daily use of Pulmozyme improves lung function and decreases the number of lung infections requiring hospital treatment Pulmozyme has been approved by the Food and Drug Administration for use in children over 5 years old and adults with cystic fibrosis Pulmozyme has also been approved by the FDA for use in children with cystic fibrosis less than 5 years old based upon studies showing that it is safe in this age group and that it does get into the airway tubes as well in infants and toddlers as it does in older children and adults Currently Pulmozyme is not widely used in children with cystic fibrosis younger than 5 years because no study has clearly shown that inhaling Pulmozyme daily improves lung function or improves clearance of mucus from the airway tubes in very young children This study will measure whether Pulmozyme improves lung function and mucous clearance from the lungs in children with cystic fibrosis less than 3 ½ years of age
This study will compare Pulmozyme to a placebo During the study infants and young children with cystic fibrosis will be treated with Pulmozyme for 6 months and placebo for 6 months The study medicines will be inhaled at home once a day from a nebulizer for a period of one year Half of the children will be treated with Pulmozyme for the first 6 months of the study and half will receive the placebo At the 6 month point the group receiving Pulmozyme will be changed to the placebo and the group receiving placebo will be changed to Pulmozyme The order of the 6 month treatment periods is randomized This study is blinded The study doctor and his staff will not know who is receiving Pulmozyme or placebo at any time during the study
Whether Pulmozyme works will be measured using infant lung function tests and by doing a special 3-D x-ray of the childs chest a high resolution CT or HRCT at the beginning of the study at 6 months and at 12 month after starting study The study will not change the regular clinical care
This study will compare Pulmozyme to a placebo During the study infants and young children with cystic fibrosis will be treated with Pulmozyme for 6 months and placebo for 6 months The study medicines will be inhaled at home once a day from a nebulizer for a period of one year Half of the children will be treated with Pulmozyme for the first 6 months of the study and half will receive the placebo At the 6 month point the group receiving Pulmozyme will be changed to the placebo and the group receiving placebo will be changed to Pulmozyme The order of the 6 month treatment periods is randomized This study is blinded The study doctor and his staff will not know who is receiving Pulmozyme or placebo at any time during the study
Whether Pulmozyme works will be measured using infant lung function tests and by doing a special 3-D x-ray of the childs chest a high resolution CT or HRCT at the beginning of the study at 6 months and at 12 month after starting study The study will not change the regular clinical care
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