Comparison of Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium and Levosalbuta… (NCT06040424) | Clinical Trial Compass
UnknownPhase 3
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
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.
Who can participate
Age range40 Years
SexALL
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Inclusion Criteria:
* Male or female patients aged 40 years and older who have been newly diagnosed or followed up with a diagnosis of COPD.
* Stable moderate-severe-very severe COPD patients with a post-bronchodilator FEV1/FVC ratio \<70% and a postbronchodilator FEV1 value \<80% at the screening visit will be included in the study.
* Symptom status such as chronic cough, sputum production, and progressive dyspnea with the BCSS (Breathlessness, Cough and Sputum Scale) Index will be evaluated, and the COPD staging of the patient with CAT (COPD Assessment Test) and the severity of dyspnea with mMRC (Modified Medical Research Council) will be determined.
* Patients with at least 10 pack/year smoking status or smoking history (patients who have quit smoking for at least 6 months or more are defined as ex-smokers).
* Patients who have not experienced an exacerbation in the previous 4 weeks.
* If the study participant is female; women using appropriate contraception (pregnancy test will be performed at screening visit).
* Patients with the ability to communicate with the investigator.
* Patients who accept to comply with the protocol.
* Patients who sign written informed consent form.
Exclusion Criteria:
* History of hypersensitivity to anticholinergics or SABAs (short acting beta agonist).
* History of COPD exacerbation or lower respiratory track infection that required treatment with antibiotic, oral or parenteral corticosteroid within the last 3 days prior the screening visi…
What they're measuring
1
FEV1 area under the curve from 0-8 h (FEV1 AUC 0-8 h)