Ignite Creation Date:
2024-05-06 @ 10:57 AM
Last Modification Date:
2024-10-26 @ 12:38 PM
Study NCT ID:
NCT03395002
Status:
COMPLETED
Last Update Posted:
2020-06-12
First Post:
2017-12-07
Brief Title:
TiotropiumSalmeterolFluticasone Fixed Dose Combination Tratment Via Discair vs Tiotropium Via Handihaler SalmeterolFluticasone Via Diskus Free Combination Treatment
Sponsor:
Neutec Ar-Ge San ve Tic AŞ
Organization:
Neutec Ar-Ge San ve Tic AŞ
Study Overview
Official Title:
Comparison of Bronchodilator Efficacy of TiotropiumSalmeterolFluticasone 950500 mcg Combination Treatment Administered Via Discair With Original Products Seretide Diskus 500 mcg Inhalation Powder Plus Spiriva 18 mcg Inhalation Powder Treatment in Patients With Moderate-severe Chronic Obstructive Pulmonary Disease COPD
Status:
COMPLETED
Status Verified Date:
2019-01
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:
None
Brief Summary:
The overall objective is to asses the bronchodilator effect of TiotropiumSalmeterolFluticasone combination delivered via Discair twice daily as compared with original products Seretide Diskus 500 mcg Inhalation Powder twice daily and Spiriva 18 mcg Inhalation Powder once daily free combination treatment in patients with stable moderate to severe COPD
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment pre-dose 15 min 30 min 1 hr 2 hr 4hr 8hr and 12hr during the first treatment day and at 16 different time points 15 min 30 min 1 hr 2 hr 4hr 6 hr 8hr and 12hr during the second treatment day
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment pre-dose 15 min 30 min 1 hr 2 hr 4hr 8hr and 12hr during the first treatment day and at 16 different time points 15 min 30 min 1 hr 2 hr 4hr 6 hr 8hr and 12hr during the second treatment day
Detailed Description:
The overall objective is to asses the bronchodilator effect of TiotropiumSalmeterolFluticasone combination delivered via Discair twice daily as compared with original products Seretide Diskus 500 mcg Inhalation Powder twice daily and Spiriva 18 mcg Inhalation Powder once daily free combination treatment in patients with stable moderate to severe COPD
For formerly diagnosed patients who met all the inclusion criteria and 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
Patients following run-in period for formerly diagnosed patients will be randomly assigned to receive TiotropiumSalmeterolFluticasone fixed dose combination as dry powder inhalation delivered via Discair twice daily or Seretide Diskus 500 mcg Inhalation Powder twice daily and Spiriva 18 mcg Inhalation Powder once daily free combination for 2-days treatment period
Patients will be evaluated at 4 consecutive visits baseline enrollment screening treatment and after treatment
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment pre-dose 15 min 30 min 1 hr 2 hr 4hr 8hr and 12hr during the first treatment day and at 16 different time points 15 min 30 min 1 hr 2 hr 4hr 6 hr 8hr and 12hr during the second treatment day
For formerly diagnosed patients who met all the inclusion criteria and 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
Patients following run-in period for formerly diagnosed patients will be randomly assigned to receive TiotropiumSalmeterolFluticasone fixed dose combination as dry powder inhalation delivered via Discair twice daily or Seretide Diskus 500 mcg Inhalation Powder twice daily and Spiriva 18 mcg Inhalation Powder once daily free combination for 2-days treatment period
Patients will be evaluated at 4 consecutive visits baseline enrollment screening treatment and after treatment
Spirometric measurements will be performed totally at 15 different time points at pretreatment and post-treatment pre-dose 15 min 30 min 1 hr 2 hr 4hr 8hr and 12hr during the first treatment day and at 16 different time points 15 min 30 min 1 hr 2 hr 4hr 6 hr 8hr and 12hr during the second treatment day
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