Ignite Creation Date:
2024-05-06 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03363503
Status:
TERMINATED
Last Update Posted:
2022-05-20
First Post:
2017-11-17
Brief Title:
SalmeterolFluticasone 50500 mcg Inhalation Powder Via Capsair vs Seretide Diskus 500 mcg Inhalation Powder in Patients With COPD
Sponsor:
Neutec Ar-Ge San ve Tic AŞ
Organization:
Neutec Ar-Ge San ve Tic AŞ
Study Overview
Official Title:
Comparison of Efficacy and Safety of SalmeterolFluticasone 50500 mcg Inhalation Powder Treatment Administered Via Capsair and Original Product Seretide Diskus 500 mcg Inhalation Powder Treatment in Patients With Moderate-severe Chronic Obstructive Pulmonary Disease COPD
Status:
TERMINATED
Status Verified Date:
2022-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Adequate number of patients could not be reached in the relevant centers
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
COPD
Brief Summary:
The aim of the current study is to compare the efficacy and safety of SalmeterolFluticasone 50500 mcg Inhalation Powder treatment administered via Capsair twice daily and original product Seretide Diskus 500 mcg Inhalation Powder treatment twice daily in patients with moderate-severe COPD
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment 5 min 15 min 30 min 1 hr 2 hr 3hr 4hr 6hr 8hr 10hr and 12hr during the treatment visits of 11-weeks study period
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment 5 min 15 min 30 min 1 hr 2 hr 3hr 4hr 6hr 8hr 10hr and 12hr during the treatment visits of 11-weeks study period
Detailed Description:
The aim of the current study is to compare the efficacy and safety of SalmeterolFluticasone 50500 mcg Inhalation Powder treatment administered via Capsair twice daily and original product Seretide Diskus 500 mcg Inhalation Powder treatment twice daily in patients with moderate-severe COPD
Patients who met all the inclusion criteria will enter a 1-week run-in period with the length determine by the specific medication during which their usual treatment will be stopped and they will receive salbutamol as required
Following run-in period patients will be randomly assigned to receive SalmeterolFluticasone 50500 mcg as dry powder capsule for inhalation by Capsair or SalmeterolFluticasone 50500 mcg as dry powder for inhalation by Diskus twice daily for 8-weeks treatment period
Patients will be evaluated at 6 consecutive visits baseline enrollment screening treatment treatment initiation after 4 and 8 weeks of treatment and after treatment will carry out by telephone two weeks following the last dose of study medication
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment 5 min 15 min 30 min 1 hr 2 hr 3hr 4hr 6hr 8hr 10hr and 12hr during the treatment visits of 11-weeks study period
Safety will be assessed through vital signs adverse events serious adverse events and all cause mortality
Patients who met all the inclusion criteria will enter a 1-week run-in period with the length determine by the specific medication during which their usual treatment will be stopped and they will receive salbutamol as required
Following run-in period patients will be randomly assigned to receive SalmeterolFluticasone 50500 mcg as dry powder capsule for inhalation by Capsair or SalmeterolFluticasone 50500 mcg as dry powder for inhalation by Diskus twice daily for 8-weeks treatment period
Patients will be evaluated at 6 consecutive visits baseline enrollment screening treatment treatment initiation after 4 and 8 weeks of treatment and after treatment will carry out by telephone two weeks following the last dose of study medication
Spirometric measurements will be performed at 12 different time points at pre-treatment and post-treatment 5 min 15 min 30 min 1 hr 2 hr 3hr 4hr 6hr 8hr 10hr and 12hr during the treatment visits of 11-weeks study period
Safety will be assessed through vital signs adverse events serious adverse events and all cause mortality
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None