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

NCT06040424 | Unknown Phase 3

• 1 other identifier: NEU-01.22
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

COPD

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (12)

• FEV1 area under the curve from 0-3 h (FEV1 AUC 0-3 h)

  3 hours

• FEV1 AUC 3-6 h

  3 to 6 hours

• FEV1 AUC 6-8 h

  6 to 8 hours

• FVC AUC 0-3 h

  3 hours

• FVC AUC 3-6 h

  3 to 6 hours

Study Arms (2)

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.

Combination Product: Ipratropium / Levosalbutamol Fixed Dose Combination

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.

Drug: Ipratropium + Levosalbutamol Free Dose Combination

Interventions

Ipratropium / Levosalbutamol Fixed Dose Combination COMBINATION_PRODUCT

New combination test treatment

Ipratropium / Levosalbutamol Fixed Dose Combination

Ipratropium + Levosalbutamol Free Dose Combination DRUG

Free combination control treatment

Ipratropium + Levosalbutamol Free Dose Combination

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 visit or during the run-in/wash-out period or history of respiratory tract infection that required treatment with antibiotic within the last 14 days prior the screening visit.
• Hospitalization due to COPD or pneumonia within the last 3 mounts prior the screening visit.
• SGOT (serum glutamic-oxaloacetic transaminase) \>80 IU/L, SGPT (serum glutamic-pyruvic transaminase) \>80 IU/L, bilirubin \>2.0 mg/dL or creatinine \>2.0 mg/dL.
• History of asthma, significant chronic respiratory diseases (i.e., significant bronchiectasis, interstitial lung diseases, etc.) other than COPD or presence of disease that may be serious and/or potentially affect results of the study.
• Use of beta-blocker, monoamine oxidase (MAO) inhibitor or tricyclic antidepressant within the last 30 days prior the screening visit
• Recent (within ≤3 months prior the screening visit) history of heart attack, heart failure, acute ischemic heart disease or presence of serious cardiac arrhythmia requiring drug treatment.
• Regularly use of daytime CPAP (continuous positive airway pressure) oxygen therapy for longer than 1 hour per day.
• Initiation of pulmonary rehabilitation within the 3 months prior the screening visit.
• History of lung volume reduction surgery
• Drug or alcohol abuse
• Presence of active tuberculosis
• History of atopy or allergic rhinitis
• Presence of active cancer
• Attenuated live virus vaccination within the last 2 weeks prior the screening visit or during the run-in/wash-out period

Sponsors & Collaborators

• Neutec Ar-Ge San ve Tic A.Ş: lead

Study Sites (1)

Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Ipratropium; Albuterol

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Parallel Group, Phase III, Non-inferiority Study

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 15, 2023
• Study Start: September 28, 2023
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2024
• Last Updated: October 3, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)