Randomized, Parallel Group, Phase III, Non-inferiority Study Comparing Ipratropium / Levosalbutamol Fixed Dose Combination in pMDI Form and Ipratropium and Salbutamol Free Dose Combination in pMDI Form in Stable Chronic Obstructive Pulmonary Disease (COPD)

NCT06040424 Phase 3 UNKNOWN

The goal of this clinical trial is to compare the acute bronchodilator effect of pMDI formed Ipratropium / Levosalbutamol 20 mcg / 50 mcg fixed dose combination or pMDI formed Salbutamol 100 mcg Inhaler and Ipratropium 20 mcg Inhalation Aerosol in combination in stable moderate-severe-very severe COPD patients.

Details

Lead sponsor	Neutec Ar-Ge San ve Tic A.Ş
Phase	Phase 3
Status	UNKNOWN
Enrolment	74
Start date	2023-09-28
Completion	2024-06

Conditions

• COPD

Interventions

• Ipratropium / Levosalbutamol Fixed Dose Combination
• Ipratropium + Levosalbutamol Free Dose Combination

Primary outcomes

• FEV1 area under the curve from 0-8 h (FEV1 AUC 0-8 h) — 8 hours
  Change From Baseline in Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC) 0-8h.

Countries

Turkey (Türkiye)