Ignite Creation Date:
2024-05-06 @ 9:37 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03028701
Status:
COMPLETED
Last Update Posted:
2020-06-16
First Post:
2017-01-18
Brief Title:
Assessment of Bronchodilator Efficacy of FormoterolBudesonide 12400 mcg Via Discair in COPD
Sponsor:
Neutec Ar-Ge San ve Tic AŞ
Organization:
Neutec Ar-Ge San ve Tic AŞ
Study Overview
Official Title:
Assessment of Bronchodilator Efficacy of FormoterolBudesonide 12400 mcg Via Discair in Chronic Obstructive Pulmonary Disease COPD
Status:
COMPLETED
Status Verified Date:
2017-01
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:
COPD
Brief Summary:
The overall objective is to asses the bronchodilator effect of single dose of FormoterolBudesonide 12400 mcg fixed combination delivered via Discair in patients with COPD
Spirometric measurements FEV1 FVC will be performed for a period of 12 h at 12 different times pretreatment prior to the first dose and posttreatment 15 min 30 min 1 hr 2 hr 3 hr 4 hr 5 hr 6 hr 8 hr 10 hr ve 12 hr
Spirometric measurements FEV1 FVC will be performed for a period of 12 h at 12 different times pretreatment prior to the first dose and posttreatment 15 min 30 min 1 hr 2 hr 3 hr 4 hr 5 hr 6 hr 8 hr 10 hr ve 12 hr
Detailed Description:
The overall objective is to asses the bronchodilator effect of single dose of FormoterolBudesonide 12400 mcg fixed dose combination delivered via Discair in patients with COPD
Patients will be assigned to receive single dose of FormoterolBudesonide 12400 mcg fixed dose combination delivered via Discair test product n 33 Patients will be evaluated at 4 consecutive visits baseline enrollment screening treatment and end of treatment 24h after treatment
For newly diagnosed and formerly diagnosed patients who are not on COPD medication the screening visit will be performed on the day of enrollment For formerly diagnosed patients receiving COPD treatment the day of the screening visit will be based on the completion of a run-in period with the length determined by the specific medication During the run-in period salbutamol 100 μg inhaler will be prescribed as a rescue medication
Spirometric measurements FEV1 FVC will be performed for a period of 12 h at 12 different times pretreatment prior to the first dose and posttreatment 15 min 30 min 1 hr 2 hr 3 hr 4 hr 5 hr 6 hr 8 hr 10 hr ve 12 hr
Patients will be assigned to receive single dose of FormoterolBudesonide 12400 mcg fixed dose combination delivered via Discair test product n 33 Patients will be evaluated at 4 consecutive visits baseline enrollment screening treatment and end of treatment 24h after treatment
For newly diagnosed and formerly diagnosed patients who are not on COPD medication the screening visit will be performed on the day of enrollment For formerly diagnosed patients receiving COPD treatment the day of the screening visit will be based on the completion of a run-in period with the length determined by the specific medication During the run-in period salbutamol 100 μg inhaler will be prescribed as a rescue medication
Spirometric measurements FEV1 FVC will be performed for a period of 12 h at 12 different times pretreatment prior to the first dose and posttreatment 15 min 30 min 1 hr 2 hr 3 hr 4 hr 5 hr 6 hr 8 hr 10 hr ve 12 hr
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