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NCT06040424Recruitment Completed

Comparison of Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium and Levosalbutamol Free Dose Combination in pMDI Form in Stable Chronic Obstructive Pulmonary Disease (COPD) Patients

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)
Neutec Ar-Ge San ve Tic A.ŞPhase 3ClinicalTrials.govcombination product
Verified
Study focus
Disease/Condition
COPD
Drug/Device/Intervention
Ipratropium / Levosalbutamol Fixed Dose Combination
Study type
Interventional
Intervention type
combination product
Sponsor & location
Primary sponsor
Neutec Ar-Ge San ve Tic A.Ş
Location
Istanbul, Turkey
Timeline & enrollment
Phase
Phase 3
Start date
Sep 28, 2023
End date
Jun 01, 2024
Enrollment
74 participants
Primary outcome

FEV1 area under the curve from 0-8 h (FEV1 AUC 0-8 h)

Summary

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.

ICD-10 classifications
Chronic obstructive pulmonary disease, unspecifiedOther chronic obstructive pulmonary diseaseOther specified chronic obstructive pulmonary diseaseChronic obstructive pulmonary disease with acute exacerbation, unspecifiedPulmonary heart disease, unspecified
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06040424
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06040424 through Pure Global AI's free database. This Phase 3 trial is sponsored by Neutec Ar-Ge San ve Tic A.Ş and is currently Recruitment Completed. The study focuses on COPD. Target enrollment is 74 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.