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

October 2, 2023 updated by: Neutec Ar-Ge San ve Tic A.Ş

Randomized, Parallel Group, Phase III, Non-inferiority Study Comparing Ipratropium / Levosalbutamol Fixed Dose Combination in pMDI Form and Ipratropium and Salbutamol Free Dose Combination in pMDI Form in Stable Chronic Obstructive Pulmonary Disease (COPD)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
74

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Ipratropium / Levosalbutamol Fixed Dose Combination
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
New combination test treatment
Active Comparator: Ipratropium + Levosalbutamol Free Dose Combination
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
Free combination control treatment

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
FEV1 area under the curve from 0-8 h (FEV1 AUC 0-8 h)
Time Frame: 8 hours
Change From Baseline in Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC) 0-8h.
8 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Time to Onset of Bronchodilator Response
Time Frame: Baseline, 0 to 8 hours post-dose at treatment day
Bronchodilator response is defined as 100 mL improvement in FEV1.
Baseline, 0 to 8 hours post-dose at treatment day
FEV1 area under the curve from 0-3 h (FEV1 AUC 0-3 h)
Time Frame: 3 hours
Change From Baseline in FEV1 AUC (0-3h).
3 hours
FEV1 AUC 3-6 h
Time Frame: 3 to 6 hours
Change From Baseline in FEV1 AUC (3-6h).
3 to 6 hours
FEV1 AUC 6-8 h
Time Frame: 6 to 8 hours
Change From Baseline in FEV1 AUC (6-8h).
6 to 8 hours
FVC AUC 0-3 h
Time Frame: 3 hours
Change From Baseline in FVC AUC (0-3h).
3 hours
FVC AUC 3-6 h
Time Frame: 3 to 6 hours
Change From Baseline in FVC AUC (3-6h).
3 to 6 hours
FVC AUC 6-8 h
Time Frame: 6 to 8 hours
Change From Baseline in FVC AUC (6-8h).
6 to 8 hours
FVC AUC 0-8 h
Time Frame: 0 to 8 hours
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)
Time Frame: Baseline, 30 minutes post-dose at treatment day
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)
Time Frame: Baseline, 1 hours post-dose at treatment day
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)
Time Frame: Baseline, 0 to 8 hours post-dose at treatment day
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
Evaluation of Safety
Time Frame: Baseline, 0 to 24 hours post-dose
Number of participants with Adverse Events, with abnormal physical examinations, abnormal laboratory test results and abnormal ECGs.
Baseline, 0 to 24 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Neutec Ar-Ge San ve Tic A.Ş

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 28, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 6, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NEU-01.22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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