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

Primary Purpose

COPD

Status
Recruiting
Phase
Phase 3
Locations
Turkey
Study Type
Interventional
Intervention
Ipratropium / Levosalbutamol Fixed Dose Combination
Ipratropium + Levosalbutamol Free Dose Combination
Sponsored by
Neutec Ar-Ge San ve Tic A.Ş
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COPD

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 Pregnancy or lactation Presence of known symptomatic prostatic hypertrophy requiring treatment Presence of known narrow-angle glaucoma requiring treatment Currently participating in another clinical trial or treatment with another investigational study drug within the last month or 6-half-lives, whichever is longer.

Sites / Locations

  • Yedikule Chest Diseases And Thoracic Surgery Training And Reseaerch HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ipratropium / Levosalbutamol Fixed Dose Combination

Ipratropium + Levosalbutamol Free Dose Combination

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

FEV1 area under the curve from 0-4 h (FEV1 AUC0-4 h)
Change From Baseline in FEV1 AUC (0-4h).
FEV1 AUC4-6 h
Change From Baseline in FEV1 AUC (4-6h).
FEV1 AUC6-8 h
Change From Baseline in FEV1 AUC (6-8h).
FVC AUC0-4 h
Change From Baseline in Forced Vital Capacity (FVC) AUC (0-4h).
FVC AUC4-6 h
Change From Baseline in FVC AUC (4-6h).
FVC AUC6-8 sa
Change From Baseline in FVC AUC (6-8h).
FVC AUC0-8 sa
Change From Baseline in FVC AUC (0-8h).
Change From Baseline in FEV1 and FVC within the first 15 minutes after dosing
Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration. The measurements at the time points related to the outcome will be evaluated.
Mean Maximum Change From Baseline in FEV1 and FVC within the first 2 hours after dosing
Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration. The measurements at the time points related to the outcome will be evaluated.
Mean Maximum Change From Baseline in FEV1 and FVC over a period of 8 hours
Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.
The Time to Onset of Bronchodilator Response
Bronchodilator response is defined as 100 mL improvement in FEV1.
Evaluation of Safety
Number of participants with Adverse Events, with abnormal physical examinations, abnormal laboratory test results and abnormal ECGs

Full Information

First Posted
December 23, 2022
Last Updated
September 1, 2023
Sponsor
Neutec Ar-Ge San ve Tic A.Ş
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1. Study Identification

Unique Protocol Identification Number
NCT05890638
Brief Title
Comparison of Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium and Levosalbutamol Free Dose Combination Nebuliser Solutions in Stable Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title
A Randomized, Parallel Group, Phase III, Non-inferiority Study Comparing Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium and Levosalbutamol Free Dose Combination Nebuliser Solutions in Stable Chronic Obstructive Pulmonary Disease (COPD)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 25, 2023 (Actual)
Primary Completion Date
February 6, 2024 (Anticipated)
Study Completion Date
March 6, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Neutec Ar-Ge San ve Tic A.Ş

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ipratropium / Levosalbutamol Fixed Dose Combination
Arm Type
Experimental
Arm Description
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.
Arm Title
Ipratropium + Levosalbutamol Free Dose Combination
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ipratropium / Levosalbutamol Fixed Dose Combination
Intervention Description
New combination test treatment
Intervention Type
Drug
Intervention Name(s)
Ipratropium + Levosalbutamol Free Dose Combination
Intervention Description
Free combination control treatment
Primary Outcome Measure Information:
Title
FEV1 area under the curve from 0-8 h (FEV1 AUC0-8 h)
Description
Change From Baseline in Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC) 0-8h.
Time Frame
8 hours
Secondary Outcome Measure Information:
Title
FEV1 area under the curve from 0-4 h (FEV1 AUC0-4 h)
Description
Change From Baseline in FEV1 AUC (0-4h).
Time Frame
4 hours
Title
FEV1 AUC4-6 h
Description
Change From Baseline in FEV1 AUC (4-6h).
Time Frame
4 to 6 hours
Title
FEV1 AUC6-8 h
Description
Change From Baseline in FEV1 AUC (6-8h).
Time Frame
6 to 8 hours
Title
FVC AUC0-4 h
Description
Change From Baseline in Forced Vital Capacity (FVC) AUC (0-4h).
Time Frame
4 hours
Title
FVC AUC4-6 h
Description
Change From Baseline in FVC AUC (4-6h).
Time Frame
4 to 6 hours
Title
FVC AUC6-8 sa
Description
Change From Baseline in FVC AUC (6-8h).
Time Frame
6 to 8 hours
Title
FVC AUC0-8 sa
Description
Change From Baseline in FVC AUC (0-8h).
Time Frame
8 hours
Title
Change From Baseline in FEV1 and FVC within the first 15 minutes after dosing
Description
Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration. The measurements at the time points related to the outcome will be evaluated.
Time Frame
Baseline, 15 minutes post-dose at treatment day.
Title
Mean Maximum Change From Baseline in FEV1 and FVC within the first 2 hours after dosing
Description
Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration. The measurements at the time points related to the outcome will be evaluated.
Time Frame
Baseline, 2 hours post-dose at treatment day
Title
Mean Maximum Change From Baseline in FEV1 and FVC over a period of 8 hours
Description
Spirometric measurements will be performed pre-treatment and 5 min, 15 min, 30 min, 45 min and 1 h, 2 h, 3 h, 4 h, 5 h, 6h, 7h, 8h after drug administration.
Time Frame
Baseline, 0 to 8 hours post-dose at treatment day
Title
The Time to Onset of Bronchodilator Response
Description
Bronchodilator response is defined as 100 mL improvement in FEV1.
Time Frame
Baseline, 0 to 8 hours post-dose at treatment day
Title
Evaluation of Safety
Description
Number of participants with Adverse Events, with abnormal physical examinations, abnormal laboratory test results and abnormal ECGs
Time Frame
Baseline, 0 to 24 hours post-dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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 Pregnancy or lactation Presence of known symptomatic prostatic hypertrophy requiring treatment Presence of known narrow-angle glaucoma requiring treatment Currently participating in another clinical trial or treatment with another investigational study drug within the last month or 6-half-lives, whichever is longer.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Neutec RD
Email
iremkaraman@neutecrdc.com
Facility Information:
Facility Name
Yedikule Chest Diseases And Thoracic Surgery Training And Reseaerch Hospital
City
Istanbul
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Didem Görgün Hattatoğlu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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