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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ipratropium / Levosalbutamol Fixed Dose Combination | Experimental | In this one-day study, patients will be administered 2 inhalation of "İPRALEV 20 mcg/50 mcg aerosol inhalasyonu, süspansiyon" at morning. |
|
| Ipratropium + Levosalbutamol Free Dose Combination | Active Comparator | In this one-day study, patients will be administered 2 inhalations of "VENTOLİN İnhaler 100 mcg" and then 2 inhalations of "ATROVENT MDI 0,02 mg/dose" at morning. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ipratropium / Levosalbutamol Fixed Dose Combination | Combination Product | New combination test treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 area under the curve from 0-8 h (FEV1 AUC 0-8 h) | Change From Baseline in Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC) 0-8h. | 8 hours |
| Measure | Description | Time Frame |
|---|---|---|
| FEV1 area under the curve from 0-3 h (FEV1 AUC 0-3 h) | Change From Baseline in FEV1 AUC (0-3h). | 3 hours |
| FEV1 AUC 3-6 h | Change From Baseline in FEV1 AUC (3-6h). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital | Istanbul | Turkey (Türkiye) |
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Randomized, Parallel Group, Phase III, Non-inferiority Study
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| Ipratropium + Levosalbutamol Free Dose Combination | Drug | Free combination control treatment |
|
| 3 to 6 hours |
| FEV1 AUC 6-8 h | Change From Baseline in FEV1 AUC (6-8h). | 6 to 8 hours |
| FVC AUC 0-3 h | Change From Baseline in FVC AUC (0-3h). | 3 hours |
| FVC AUC 3-6 h | Change From Baseline in FVC AUC (3-6h). | 3 to 6 hours |
| FVC AUC 6-8 h | Change From Baseline in FVC AUC (6-8h). | 6 to 8 hours |
| FVC AUC 0-8 h | Change From Baseline in FVC AUC (0-8h). | 0 to 8 hours |
| Change From Baseline in FEV1 and FVC within the first 30 minutes after dosing (mL) | Spirometric measurements will be performed pre-treatment and 5 min, 30 min and 1 h, 3 h, 6h, 8h after drug administration. The measurements at the time points related to the outcome will be evaluated. | Baseline, 30 minutes post-dose at treatment day |
| Mean Maximum Change From Baseline in FEV1 and FVC within the first 1 hours after dosing (mL) | Spirometric measurements will be performed pre-treatment and 5 min, 30 min and 1 h, 3 h, 6h, 8h after drug administration. The measurements at the time points related to the outcome will be evaluated. | Baseline, 1 hours post-dose at treatment day |
| Mean Maximum Change From Baseline in FEV1 and FVC over a period of 8 hours (mL) | Spirometric measurements will be performed pre-treatment and 5 min, 30 min and 1 h, 3 h, 6h, 8h after drug administration. The measurements at the time points related to the outcome will be evaluated. | 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. | 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. | Baseline, 0 to 24 hours post-dose |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D009241 | Ipratropium |
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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