COPDPhase 3NCT05890638
Comparison of Ipratropium / Levosalbutamol Fixed Dose Combination and Ipratropium and Levosalbutamol Free Dose Combination Nebuliser Solutions 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).
Trial 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… 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
- 25 Aug 2023to 6 Mar 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.
Neutec RD contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Yedikule Chest Diseases And Thoracic Surgery Training And Reseaerch Hospital
Istanbul
Didem Görgün Hattatoğlu
About this study
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)
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
- 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 CombinationDrug
New combination test treatment
Ipratropium + Levosalbutamol Free Dose CombinationDrug
Free combination control treatment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. 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 AUC0-8 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 0-4 h (FEV1 AUC0-4 h)
Change From Baseline in FEV1 AUC (0-4h).
Measured: 4 hours
FEV1 AUC4-6 h
Change From Baseline in FEV1 AUC (4-6h).
Measured: 4 to 6 hours
FEV1 AUC6-8 h
Change From Baseline in FEV1 AUC (6-8h).
Measured: 6 to 8 hours
FVC AUC0-4 h
Change From Baseline in Forced Vital Capacity (FVC) AUC (0-4h).
Measured: 4 hours
FVC AUC4-6 h
Change From Baseline in FVC AUC (4-6h).
Measured: 4 to 6 hours
FVC AUC6-8 sa
Change From Baseline in FVC AUC (6-8h).
Measured: 6 to 8 hours
FVC AUC0-8 sa
Change From Baseline in FVC AUC (0-8h).
Measured: 8 hours
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.
Measured: Baseline, 15 minutes post-dose at treatment day.
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.
Measured: Baseline, 2 hours post-dose at treatment day
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.
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.
- First posted6 Jun 2023
- Study start25 Aug 2023
- Primary completion6 Feb 2024 (estimated)
- Study completion6 Mar 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
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neutec Ar-Ge San ve Tic A.Ş
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890638
- Sponsor's protocol ID
- NEU-02.22
- Status last verified
- Sep 2023
- First submitted
- 23 Dec 2022
- Last updated
- 5 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05890638
- Acronym / sponsor ID
- NEU-02.22
- 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
- 25 Aug 2023 (actual)
- Primary completion
- 6 Feb 2024 (estimated)
- Study completion
- 6 Mar 2024 (estimated)
- First posted
- 6 Jun 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ipratropium / Levosalbutamol Fixed Dose Combination | Experimental | Drug: Ipratropium / Levosalbutamol Fixed Dose CombinationIn 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. |
| Ipratropium + Levosalbutamol Free Dose Combination | Active comparator | Drug: Ipratropium + Levosalbutamol Free Dose CombinationIn 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. |
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 | Drug | 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 AUC0-8 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 0-4 h (FEV1 AUC0-4 h)
Time frame: 4 hours
FEV1 AUC4-6 h
Time frame: 4 to 6 hours
FEV1 AUC6-8 h
Time frame: 6 to 8 hours
FVC AUC0-4 h
Time frame: 4 hours
FVC AUC4-6 h
Time frame: 4 to 6 hours
FVC AUC6-8 sa
Time frame: 6 to 8 hours
FVC AUC0-8 sa
Time frame: 8 hours
Change From Baseline in FEV1 and FVC within the first 15 minutes after dosing
Time frame: Baseline, 15 minutes post-dose at treatment day.
Mean Maximum Change From Baseline in FEV1 and FVC within the first 2 hours after dosing
Time frame: Baseline, 2 hours post-dose at treatment day
Mean Maximum Change From Baseline in FEV1 and FVC over a period of 8 hours
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 5 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Neutec RD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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).
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 5 Sep 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?
Contact Neutec RD (iremkaraman@neutecrdc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FEV1 area under the curve from 0-8 h (FEV1 AUC0-8 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?
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 5 Sep 2023.