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).
The overall objective is to asses the bronchodilator effect of single dose of Formoterol/Budesonide 12/400 mcg fixed dose combination delivered via Discair® in patients with COPD. Patients will be assigned to receive single dose of Formoterol/Budesonide 12/400 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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
33
Formoterol/Budesonide 12/400 mcg Inhalation Powder (1 puff) once daily via Discair®
Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital
Istanbul, Turkey (Türkiye)
Mean max improvement (ml) from baseline in FEV1 over a period of 12 h.
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.
Time frame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
The time to onset of max improvement from baseline in FEV1.
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.
Time frame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
Mean absolute change (ml) from baseline in FEV1 over a period of 12 h (over spirometric measurement period).
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.
Time frame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
Mean absolute change (ml) from baseline in FVC over a period of 12 h (over spirometric measurement period).
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.
Time frame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
Mean % change from baseline in FEV1 over a period of 12 h (over spirometric measurement period).
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.
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Time frame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
Mean % change from baseline in FVC over a period of 12 h (over spirometric measurement period).
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.
Time frame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
FEV1 (AUC0-12) response
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.
Time frame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
FVC (AUC0-12) response
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.
Time frame: Pretreatment (prior to the first dose of study medication) and posttreatment (Day 1)
Evaluation of safety
(Physical examination, numbers of adverse reactions and abnormal laboratory values related
Time frame: Predose and up to 12 hours postdose