Assessment of Bronchodilator Efficacy of Formoterol/Budesonide 12/400 mcg Via Discair in Chronic Obstructive Pulmonary Disease (COPD)

NCT03028701 Phase 4 COMPLETED

The overall objective is to asses the bronchodilator effect of single dose of Formoterol/Budesonide 12/400 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).

Details

Lead sponsor	Neutec Ar-Ge San ve Tic A.Ş
Phase	Phase 4
Status	COMPLETED
Enrolment	33
Start date	2015-09
Completion	2017-03

Conditions

• Copd

Interventions

• Formoterol/Budesonide 12/400 mcg Discair

Primary outcomes

• Mean max improvement (ml) from baseline in FEV1 over a period of 12 h. — Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
  Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr.
• The time to onset of max improvement from baseline in FEV1. — Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
  Spirometric measurements will be made at prior to the first dose of study medication and and posttreatment at 15 min, 30 min, 1 hr, 2 hr, 3 hr, 4 hr, 5 hr, 6 hr, 8 hr, 10 hr and 12 hr.

Countries

Turkey (Türkiye)