The goal of this clinical trial is to compare the acute bronchodilator effect of the Ipratropium / Levosalbutamol 1.25 mg \& 0.5 mg / 2.5 mL fixed dose combination nebuliser solution or Levosalbutamol 1.25 mg / 3 mL nebuliser solution and Ipratropium 500 mcg nebuliser solution in stable moderate-severe-very severe COPD patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
74
New combination test treatment
Free combination control treatment
Yedikule Chest Diseases And Thoracic Surgery Training And Reseaerch Hospital
Istanbul, Turkey (Türkiye)
RECRUITINGFEV1 area under the curve from 0-8 h (FEV1 AUC0-8 h)
Change From Baseline in Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC) 0-8h.
Time frame: 8 hours
FEV1 area under the curve from 0-4 h (FEV1 AUC0-4 h)
Change From Baseline in FEV1 AUC (0-4h).
Time frame: 4 hours
FEV1 AUC4-6 h
Change From Baseline in FEV1 AUC (4-6h).
Time frame: 4 to 6 hours
FEV1 AUC6-8 h
Change From Baseline in FEV1 AUC (6-8h).
Time frame: 6 to 8 hours
FVC AUC0-4 h
Change From Baseline in Forced Vital Capacity (FVC) AUC (0-4h).
Time frame: 4 hours
FVC AUC4-6 h
Change From Baseline in FVC AUC (4-6h).
Time frame: 4 to 6 hours
FVC AUC6-8 sa
Change From Baseline in FVC AUC (6-8h).
Time frame: 6 to 8 hours
FVC AUC0-8 sa
Change From Baseline in FVC AUC (0-8h).
Time frame: 8 hours
Change From Baseline in FEV1 and FVC within the first 15 minutes after dosing
Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration. The measurements at the time points related to the outcome will be evaluated.
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Time frame: Baseline, 15 minutes post-dose at treatment day.
Mean Maximum Change From Baseline in FEV1 and FVC within the first 2 hours after dosing
Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration. The measurements at the time points related to the outcome will be evaluated.
Time frame: Baseline, 2 hours post-dose at treatment day
Mean Maximum Change From Baseline in FEV1 and FVC over a period of 8 hours
Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.
Time frame: Baseline, 0 to 8 hours post-dose at treatment day
The Time to Onset of Bronchodilator Response
Bronchodilator response is defined as 100 mL improvement in FEV1.
Time frame: Baseline, 0 to 8 hours post-dose at treatment day
Evaluation of Safety
Number of participants with Adverse Events, with abnormal physical examinations, abnormal laboratory test results and abnormal ECGs
Time frame: Baseline, 0 to 24 hours post-dose