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

NCT05890638 | Unknown Phase 3

• 1 other identifier: NEU-02.22
• 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 the Ipratropium / Levosalbutamol 1.25 mg \& 0.5 mg / 2.5 mL fixed dose combination nebuliser solution or Levosalbutamol 1.25 mg / 3 mL nebuliser solution and Ipratropium 500 mcg nebuliser solution 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 AUC0-8 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 0-4 h (FEV1 AUC0-4 h)

  4 hours

• FEV1 AUC4-6 h

  4 to 6 hours

• FEV1 AUC6-8 h

  6 to 8 hours

• FVC AUC0-4 h

  4 hours

• FVC AUC4-6 h

  4 to 6 hours

Study Arms (2)

Ipratropium / Levosalbutamol Fixed Dose Combination

EXPERIMENTAL

In this one-day study, patients will be administered "Ipratropium / Levosalbutamol 1.25 mg \& 0.5 mg / 2.5 mL Nebuliser Solution" at 6 hours intervals.

Drug: Ipratropium / Levosalbutamol Fixed Dose Combination

Ipratropium + Levosalbutamol Free Dose Combination

ACTIVE COMPARATOR

In this one-day study, patients will be administered "Levosalbutamol 1.25 mg/3 mL Inhalation Solution" and "Ipratropium Nebulization Solution 500 mcg/2 mL" at 6 hours intervals.

Drug: Ipratropium + Levosalbutamol Free Dose Combination

Interventions

Ipratropium / Levosalbutamol Fixed Dose Combination DRUG

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 Training And Reseaerch Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

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

Central Study Contacts

Neutec RD

CONTACT

iremkaraman@neutecrdc.com

Study Design

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

Study Record Dates

• First Submitted: December 23, 2022
• First Posted: June 6, 2023
• Study Start: August 25, 2023
• Primary Completion: February 6, 2024
• Study Completion: March 6, 2024
• Last Updated: September 5, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)