A Phase 3 interventional study of Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium + Levosalbutamol Free Dose Combination in COPD, sponsored by Neutec Ar-Ge San ve Tic A.Ş. Active, not recruiting at 1 site in Turkey. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2023-10-03.
Sponsored by Neutec Ar-Ge San ve Tic A.Ş · Phase 3, Interventional, and Treatment
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.
5,520 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 856 are open to participants now.
This study's planned enrollment of 74 is above the median of 62 across 3,839 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.
Browse Pulmonary Disease, Chronic Obstructive studies →Neutec Ar-Ge San ve Tic A.Ş is the lead sponsor of 20 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FEV1
From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
Drug pages: Ipratropium · Levalbuterol
New combination test treatment
Free combination control treatment
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.
Time frame: 8 hours
FEV1 area under the curve from 0-3 h (FEV1 AUC 0-3 h)
Change From Baseline in FEV1 AUC (0-3h).
Time frame: 3 hours
FEV1 AUC 3-6 h
Change From Baseline in FEV1 AUC (3-6h).
Time frame: 3 to 6 hours
FEV1 AUC 6-8 h
Change From Baseline in FEV1 AUC (6-8h).
Time frame: 6 to 8 hours
FVC AUC 0-3 h
Change From Baseline in FVC AUC (0-3h).
Time frame: 3 hours
FVC AUC 3-6 h
Change From Baseline in FVC AUC (3-6h).
Time frame: 3 to 6 hours
FVC AUC 6-8 h
Change From Baseline in FVC AUC (6-8h).
Time frame: 6 to 8 hours
FVC AUC 0-8 h
Change From Baseline in FVC AUC (0-8h).
Time frame: 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.
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)
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.
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)
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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, 0 to 24 hours post-dose
Plan to share: No
No publications or documents are linked to this record.
Started Sep 2023 (actual). Primary completion is estimated for Jun 2024, 9 months after the start.
Of 108 industry-sponsored phase 3 interventional studies under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 36. This study's planned 9 months is below that.
Counting every sponsor, half of 141 studies reached it within 23 months; a quarter within 14 and three quarters within 44.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Ipratropium · Levalbuterol
Pulmonary Disease, Chronic Obstructive →
Neutec Ar-Ge San ve Tic A.Ş