Ignite Creation Date:
2024-05-05 @ 9:42 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005110
Status:
SUSPENDED
Last Update Posted:
2005-06-24
First Post:
2000-04-13
Brief Title:
A Multi-Centered Study of the Long-Term Effect of Salmeterol and Albuterol in Cystic Fibrosis
Sponsor:
National Center for Research Resources NCRR
Organization:
National Center for Research Resources NCRR
Study Overview
Official Title:
None
Status:
SUSPENDED
Status Verified Date:
2001-11
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:
Long term use of bronchodilators in CF is beneficial to the improvement of pulmonary function and symptoms This study is investigating the long-term benefit of administration of the drug Salmeterol a bronchodilator Salmeterol will be compared to albuterol or placebo The medication will be inhaled twice a day for 6 months
Detailed Description:
Patients that have been diagnosed with cystic fibrosis and are above 5 years and below 45 years of age are eligible Subjects will be randomized into 1 of 3 groups One group will get Salmeterol by multi-dose inhaler MDI 2 puffs 2 times a day one group will get albuterol by MDI 2 puffs 2 times a day and the other will get placebo by MDI 2 puffs 2 times a day Height and weight along with pulmonary function testing and vital signs will be monitored at the beginning of the study and at Visits 2 3 and 4 Peak flow monitoring will be done each morning before study medication at home A daily diary will be kept of this measurement Subjects will be seen in the research center at visits 123 and 4 Telephone contact will be done at Day 15 60 120 and 150 Individual outcomes include a potential increase in pulmonary function testing and a decrease in frequency of pulmonary exacerbations hospitalizations and usage of antibiotics
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| M01RR000036 | NIH | None | httpsreporternihgovquickSearchM01RR000036 |