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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 - Trial NCT06040424

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.ลž 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.

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NCT06040424
Phase 3
Recruitment Completed
combination product
Trial Details
ClinicalTrials.gov โ€ข NCT06040424
View on ClinicalTrials.gov
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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)

Study Focus

COPD

Ipratropium / Levosalbutamol Fixed Dose Combination

Interventional

combination product

Sponsor & Location

Neutec Ar-Ge San ve Tic A.ลž

Istanbul, Turkey

Timeline & Enrollment

Phase 3

Sep 28, 2023

Jun 01, 2024

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, unspecified
Other chronic obstructive pulmonary disease
Other specified chronic obstructive pulmonary disease
Chronic obstructive pulmonary disease with acute exacerbation, unspecified
Pulmonary heart disease, unspecified

Data Source

ClinicalTrials.gov

NCT06040424

Non-Device Trial