Ignite Creation Date:
2024-05-06 @ 9:28 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02988869
Status:
COMPLETED
Last Update Posted:
2020-06-16
First Post:
2016-10-06
Brief Title:
TiotropiumFormoterol Via Discair vs Tiotropium Monotherapy or Tiotropium Formoterol 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 TiotropiumFormoterol Combination Treatment Administered qd Via Discair With Tiotropium qd Monotherapy or Tiotropium qd Formoterol Bid Free Combination Treatment in Patients With Chronic Obstructive Pulmonary Disease COPD
Status:
COMPLETED
Status Verified Date:
2017-12
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 once daily TiotropiumFormoterol combination delivered via Discair by comparing Tiotropium qd monotherapy delivered via Handihaler and tiotropium qd delivered via Handihaler formoterol bid delivered via Aerolizer free combination treatment in patients with stable moderate to severe COPD
Spirometric measurements FEV1 FVC will be performed for a period of 24 h at 12 different times pre-treatment 15 min prior to the first dose and post-treatment 30 min 60 min 1 hr 120 min 2 hr 180 min 3 hr 240 min 4 hr 360 min 6 hr 480 min 8 hr 600 min 10 hr 720 min 12 hr 840 min 14 hr1440 min 24 hr
Spirometric measurements FEV1 FVC will be performed for a period of 24 h at 12 different times pre-treatment 15 min prior to the first dose and post-treatment 30 min 60 min 1 hr 120 min 2 hr 180 min 3 hr 240 min 4 hr 360 min 6 hr 480 min 8 hr 600 min 10 hr 720 min 12 hr 840 min 14 hr1440 min 24 hr
Detailed Description:
The overall objective is to asses the bronchodilator effect of once daily TiotropiumFormoterol combination delivered via Discair by comparing Tiotropium qd monotherapy delivered via Handihaler and tiotropium qd delivered via Handihaler formoterol bid delivered via Aerolizer free combination treatment in patients with stable moderate to severe COPD
Patients will be randomly assigned to receive TiotropiumFormoterol combination as dry powder for inhalation by Discair test inhaler n 29 or Tiotropium as dry powder capsule for inhalation by HandiHaler or tiotropium dry powder capsule for inhalation by HandiHaler formoterol as dry powder capsule for inhalation by Aerolizer Patients will be evaluated at 4 consecutive visits baseline enrollment screening treatment and 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 24 h at 12 different times pre-treatment 15 min prior to the first dose and post-treatment 30 min 60 min 1 hr 120 min 2 hr 180 min 3 hr 240 min 4 hr 360 min 6 hr 480 min 8 hr 600 min 10 hr 720 min 12 hr 840 min 14 hr1440 min 24 hr
Patients will be randomly assigned to receive TiotropiumFormoterol combination as dry powder for inhalation by Discair test inhaler n 29 or Tiotropium as dry powder capsule for inhalation by HandiHaler or tiotropium dry powder capsule for inhalation by HandiHaler formoterol as dry powder capsule for inhalation by Aerolizer Patients will be evaluated at 4 consecutive visits baseline enrollment screening treatment and 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 24 h at 12 different times pre-treatment 15 min prior to the first dose and post-treatment 30 min 60 min 1 hr 120 min 2 hr 180 min 3 hr 240 min 4 hr 360 min 6 hr 480 min 8 hr 600 min 10 hr 720 min 12 hr 840 min 14 hr1440 min 24 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