COPDPhase 3NCT06040424

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

A Phase 3 study testing Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium + Levosalbutamol Free Dose Combination in people with COPD, run by Neutec Ar-Ge San ve Tic A.Ş at 1 site in Turkey (Türkiye).

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: COPD
What is being tested?: Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium + Levosalbutamol Free Dose Combination
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 74 participants
Where: 1 siteTurkey (Türkiye)
Study dates: 28 Sep 2023to Jun 2024
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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).

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Patients with the ability to communicate with the investigator.
Patients who accept to comply with the protocol.
Patients who sign written informed consent form.

Who cannot join

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

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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.

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site

Yedikule Chest Diseases and Thoracic Surgery Education and Research Hospital
Istanbul

Other trials in Turkey (Türkiye)

About this study

Official title: 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)

Conditions: COPD
Being tested: Ipratropium / Levosalbutamol Fixed Dose Combination, Ipratropium + Levosalbutamol Free Dose Combination
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ipratropium / Levosalbutamol Fixed Dose CombinationCombination product
New combination test treatment
Ipratropium + Levosalbutamol Free Dose CombinationDrug
Free combination control treatment

Study groups in NCT06040424
Study group	Role	What they receive
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. Receives: 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. Receives: Drug: Ipratropium + Levosalbutamol Free Dose Combination

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 8 hours

Secondary outcomes (12)

FEV1 area under the curve from 0-3 h (FEV1 AUC 0-3 h)
Change From Baseline in FEV1 AUC (0-3h).
Measured: 3 hours
FEV1 AUC 3-6 h
Change From Baseline in FEV1 AUC (3-6h).
Measured: 3 to 6 hours
FEV1 AUC 6-8 h
Change From Baseline in FEV1 AUC (6-8h).
Measured: 6 to 8 hours
FVC AUC 0-3 h
Change From Baseline in FVC AUC (0-3h).
Measured: 3 hours
FVC AUC 3-6 h
Change From Baseline in FVC AUC (3-6h).
Measured: 3 to 6 hours
FVC AUC 6-8 h
Change From Baseline in FVC AUC (6-8h).
Measured: 6 to 8 hours
FVC AUC 0-8 h
Change From Baseline in FVC AUC (0-8h).
Measured: 0 to 8 hours
Change From Baseline in FEV1 and FVC within the first 30 minutes after dosing (mL)
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.
Measured: 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)
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.
Measured: Baseline, 1 hours post-dose at treatment day
Mean Maximum Change From Baseline in FEV1 and FVC over a period of 8 hours (mL)
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.
Measured: Baseline, 0 to 8 hours post-dose at treatment day
The Time to Onset of Bronchodilator Response
Bronchodilator response is defined as 100 mL improvement in FEV1.
Measured: Baseline, 0 to 8 hours post-dose at treatment day
Evaluation of Safety
Number of participants with Adverse Events, with abnormal physical examinations, abnormal laboratory test results and abnormal ECGs.
Measured: Baseline, 0 to 24 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

28 Sep 2023Jun 2024

First posted15 Sep 2023
Study start28 Sep 2023
Primary completionJun 2024 (estimated)
Study completionJun 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for COPDStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Randomized, Parallel Group, Phase III, Non-inferiority Study
Masking: None (open label)
Enrolment: 74 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06040424
Sponsor's protocol ID: NEU-01.22
Status last verified: Oct 2023
First submitted: 6 Sep 2023
Last updated: 3 Oct 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All COPD trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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)
ClinicalTrials.gov ID: NCT06040424
Acronym / sponsor ID: NEU-01.22
Conditions: COPD
Phase: Phase 3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 74 participants (estimated)
Lead sponsor: Neutec Ar-Ge San ve Tic A.ŞIndustry (pharma, biotech, devices)
Study start: 28 Sep 2023 (actual)
Primary completion: Jun 2024 (estimated)
Study completion: Jun 2024 (estimated)
First posted: 15 Sep 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2
Model description: Randomized, Parallel Group, Phase III, Non-inferiority Study

Arm	Type	Receives
Ipratropium / Levosalbutamol Fixed Dose Combination	Experimental	Combination Product: Ipratropium / Levosalbutamol Fixed Dose CombinationIn this one-day study, patients will be administered 2 inhalation of "İPRALEV 20 mcg/50 mcg aerosol inhalasyonu, süspansiyon" at morning.
Ipratropium + Levosalbutamol Free Dose Combination	Active comparator	Drug: Ipratropium + Levosalbutamol Free Dose CombinationIn 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.

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

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.

Key exclusion criteria (19 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ipratropium / Levosalbutamol Fixed Dose CombinationNew combination test treatment	Combination product	Ipratropium / Levosalbutamol Fixed Dose Combination
Ipratropium + Levosalbutamol Free Dose CombinationFree combination control treatment	Drug	Ipratropium + Levosalbutamol Free Dose Combination

Primary outcome

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.

12 secondary outcomes

FEV1 area under the curve from 0-3 h (FEV1 AUC 0-3 h)
Time frame: 3 hours
FEV1 AUC 3-6 h
Time frame: 3 to 6 hours
FEV1 AUC 6-8 h
Time frame: 6 to 8 hours
FVC AUC 0-3 h
Time frame: 3 hours
FVC AUC 3-6 h
Time frame: 3 to 6 hours
FVC AUC 6-8 h
Time frame: 6 to 8 hours
FVC AUC 0-8 h
Time frame: 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
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
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
The Time to Onset of Bronchodilator Response
Time frame: Baseline, 0 to 8 hours post-dose at treatment day
Evaluation of Safety
Time frame: Baseline, 0 to 24 hours post-dose

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2023.
Individual participant dataSharing planned: No

Related trials for COPD

Active, not recruiting
Symptoms and Functions in Patients With COPD and Chronic Bronchitis Switching From CIG to THS
COPD, Smoking
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Not yet recruiting
The Aim of the Study is to Decipher the Alterations in Signalling Pathways of Skeletal Muscle Stem Cells (Satellite Cells (SCs)) in Individuals With COPD, as Well as to Examine the Effect of Exercise Training on SCs.
COPD (Chronic Obstructive Pulmonary Disease), Sarcopenia in Elderly
Not yet recruitingPhase 2
Study of Treprostinil Administered Via Soft Mist Inhaler (SMI) in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 1
A Study for GSK3862995B in Healthy Participants and Participants With Chronic Obstructive Pulmonary Disease
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

FEV1 area under the curve from 0-8 h (FEV1 AUC 0-8 h) (time frame: 8 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06040424.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2023.