Chronic Obstructive Pulmonary DiseasePhase 3NCT04446637

Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination vs Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol Free Combination in Patients With Stable COPD

A Phase 3 study testing Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination (2 inhalations) via pMDI and Salbutamol 100 mcg Inhaler (2 inhalations) + Ipratropium 20 mcg Inhalation Aerosol (2 inhalations) Free Combination via MDI in people with Chronic Obstructive Pulmonary Disease, run by Neutec Ar-Ge San ve Tic A.Ş.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

The purpose of this study is to compare acute bronchodilator effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination (2 inhalations) via pMDI and Salbutamol 100 mcg Inhaler (2 inhalations) plus Ipratropium 20 mcg Inhalation Aerosol (2 inhalations) Free Combination in Patients with stable… Read more about this study

Who is it for?: Ages 40 to 120 years
Conditions the study is for: Chronic Obstructive Pulmonary Disease
What is being tested?: Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination (2 inhalations) via pMDI and Salbutamol 100 mcg Inhaler (2 inhalations) + Ipratropium 20 mcg Inhalation Aerosol (2 inhalations) Free Combination via MDI
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: 3 Sep 2021to 3 Sep 2022
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 to 120 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Female and male patients aged ≥40 years diagnosed with symptomathic stable moderate-severe-very severe COPD: post-bronchodilator FEV1/FVC <70% predicted and a post-bronchodilator FEV1 <80% predicted at screen visit.
Group B COPD CAT: ≥10 or mMRC: ≥ 2 Exacerbation: 0-1 (not leading to hospital admission)
Group C COPD CAT: <10 or mMRC: 0-1 Exacerbation: ≥2 (not leading to hospital admission) or ≥1 (leading to hospital admission)
Group D COPD CAT: ≥10 or mMRC: ≥ 2 Exacerbation: ≥2 (not leading to hospital admission) or ≥1 (leading to hospital admission)
Current or ex-smokers with a smoking history of at least 10 pack-years
Patients who have no exacerbation within the last 4 weeks

Show all 10Show fewer

Female patients who use effective contraception
Patients who have a capability to communicate with investigator
Patients who accept to comply with the protocol
Patients who sign written informed consent form

Who cannot join

History of hypersensitive to anticholinergics or SABAs
History of COPD exacerbation or lower respiratory track infection that required treatment with antibiotic, oral or parenteral corticosteroid within the last 4 weeks 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
Use of oral corticosteroid at unstable dosages (i.e. <6 weeks on a stable dose of prednisone)
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.

Show all 21Show fewer

Initiation of an inhaled steroid or change in dose within <6 weeks prior the screening visit
Use of beta-blocker, monoamine oxidase (MAO) inhibitor or tricyclic antidepressant within the last 30 days prior the screening visit
Recent (within ≤1 year 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 measure) 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
History of cancer within the last 5 years
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.

About this study

Official title: Comparison of Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination Delivered Via pMDI and Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol in Patients With Stable Moderate-Severe-Very Severe Chronic Obstructive Pulmonary Disease (COPD).

Conditions: Chronic Obstructive Pulmonary Disease
Being tested: Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination (2 inhalations) via pMDI, Salbutamol 100 mcg Inhaler (2 inhalations) + Ipratropium 20 mcg Inhalation Aerosol (2 inhalations) Free Combination via MDI
Keywords: COPD, ipratropium, levosalbutamol, levalbuterol, salbutamol, albuterol, MDI
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 20/50 mcg Fixed Dose Combination (2 inhalations) via pMDIDrug
Also called IPRALEV 20 mcg/50 mcg Aerosol Inhalation, Suspension
Ipratropium/Levosalbutamol 20 mcg/50 mcg Aerosol Inhalation, Suspension 2 inhalations in the morning (single day)
Salbutamol 100 mcg Inhaler (2 inhalations) + Ipratropium 20 mcg Inhalation Aerosol (2 inhalations) Free Combination via MDIDrug
Also called VENTOLİN İnhaler 100 mcg + ATROVENT N MDI 0,02 mg/dose
Salbutamol 100 mcg Inhaler, 2 inhalations + Ipratropium 20 mcg Inhalation Aerosol,2 inhalations in the morning (single day).

Study groups in NCT04446637
Study group	Role	What they receive
Ipratropium/Levosalbutamol	Experimental	Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination (2 inhalations) via pMDI Receives: Drug: Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination (2 inhalations) via pMDI
Salbutamol + Ipratropium	Active comparator	Salbutamol 100 mcg Inhaler (2 inhalations) + Ipratropium 20 mcg Inhalation Aerosol (2 inhalations) Free Combination via MDI Receives: Drug: Salbutamol 100 mcg Inhaler (2 inhalations) + Ipratropium 20 mcg Inhalation Aerosol (2 inhalations) Free Combination via MDI

What is being measured

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

FEV1 AUC (0-8h)
Change From Baseline in Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC) 0-8h.
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

Secondary outcomes (14)

FEV1 AUC (0-4h)
Change From Baseline in FEV1 AUC (0-4h). 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 4 hours post-dose at treatment day
FEV1 AUC (4-6h)
Change From Baseline in FEV1 AUC (4-6h). 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, 4 to 6 hours post-dose at treatment day
FEV1 AUC (6-8h)
Change From Baseline in FEV1 AUC (6-8h). 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, 6 to 8 hours post-dose at treatment day
FVC AUC (0-4h)
Change From Baseline in Forced Vital Capacity (FVC) AUC (0-4h). 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 4 hours post-dose at treatment day
FVC AUC (4-6h)
Change From Baseline in FVC AUC (4-6h). 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, 4 to 6 hours post-dose at treatment day
FVC AUC (6-8h)
Change From Baseline in FVC AUC (6-8h). 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, 6 to 8 hours post-dose at treatment day
FVC AUC (0-8h)
Change From Baseline in FVC AUC (0-8h). 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
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.
Measured: Baseline, 0 to 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.
Measured: Baseline, 0 to 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. 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 Maximum Effect
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
Duration of Bronchodilator Response
Bronchodilator response is defined as 100 mL improvement in FEV1. 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
Evaluation of Safety (physical examination, numbers of adverse reactions and abnormal laboratory values or ECG related to treatment)
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.

3 Sep 20213 Sep 2022

First posted25 Jun 2020
Study start3 Sep 2021 (estimated)
Primary completion3 Sep 2022 (estimated)
Study completion3 Sep 2022 (estimated)

Why it stopped: administrative decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Chronic Obstructive Pulmonary DiseaseStudies 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: Multicenter, single day, noninferiority study
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04446637
Sponsor's protocol ID: NEU-01.19
Status last verified: Sep 2021
First submitted: 23 Jun 2020
Last updated: 13 Sep 2021
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?

Official record

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All Chronic Obstructive Pulmonary Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Acute Bronchodilator Effects of Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination Delivered Via pMDI and Salbutamol 100 mcg Inhaler Plus Ipratropium 20 mcg Inhalation Aerosol in Patients With Stable Moderate-Severe-Very Severe Chronic Obstructive Pulmonary Disease (COPD).
ClinicalTrials.gov ID: NCT04446637
Acronym / sponsor ID: NEU-01.19
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD, ipratropium, levosalbutamol, levalbuterol, salbutamol, albuterol, MDI
Phase: Phase 3
Study type: Interventional
Recruitment status: WithdrawnReason stopped: administrative decision
Enrolment: 0 participants (actual)
Lead sponsor: Neutec Ar-Ge San ve Tic A.ŞIndustry (pharma, biotech, devices)
Study start: 3 Sep 2021 (estimated)
Primary completion: 3 Sep 2022 (estimated)
Study completion: 3 Sep 2022 (estimated)
First posted: 25 Jun 2020 (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: Multicenter, single day, noninferiority study

Arm	Type	Receives
Ipratropium/Levosalbutamol	Experimental	Drug: Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination (2 inhalations) via pMDIIpratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination (2 inhalations) via pMDI
Salbutamol + Ipratropium	Active comparator	Drug: Salbutamol 100 mcg Inhaler (2 inhalations) + Ipratropium 20 mcg Inhalation Aerosol (2 inhalations) Free Combination via MDISalbutamol 100 mcg Inhaler (2 inhalations) + Ipratropium 20 mcg Inhalation Aerosol (2 inhalations) Free Combination via MDI

Who may qualify

Ages: 40 to 120 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Female and male patients aged ≥40 years diagnosed with symptomathic stable moderate-severe-very severe COPD: post-bronchodilator FEV1/FVC <70% predicted and a post-bronchodilator FEV1 <80% predicted at screen visit.
Group B COPD CAT: ≥10 or mMRC: ≥ 2 Exacerbation: 0-1 (not leading to hospital admission)
Group C COPD CAT: <10 or mMRC: 0-1 Exacerbation: ≥2 (not leading to hospital admission) or ≥1 (leading to hospital admission)
Group D COPD CAT: ≥10 or mMRC: ≥ 2 Exacerbation: ≥2 (not leading to hospital admission) or ≥1 (leading to hospital admission)
Current or ex-smokers with a smoking history of at least 10 pack-years

Key exclusion criteria (21 listed)

History of hypersensitive to anticholinergics or SABAs
History of COPD exacerbation or lower respiratory track infection that required treatment with antibiotic, oral or parenteral corticosteroid within the last 4 weeks 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
Use of oral corticosteroid at unstable dosages (i.e. <6 weeks on a stable dose of prednisone)
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

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 20/50 mcg Fixed Dose Combination (2 inhalations) via pMDIAlso: IPRALEV 20 mcg/50 mcg Aerosol Inhalation, SuspensionIpratropium/Levosalbutamol 20 mcg/50 mcg Aerosol Inhalation, Suspension 2 inhalations in the morning (single day)	Drug	Ipratropium/Levosalbutamol
Salbutamol 100 mcg Inhaler (2 inhalations) + Ipratropium 20 mcg Inhalation Aerosol (2 inhalations) Free Combination via MDIAlso: VENTOLİN İnhaler 100 mcg + ATROVENT N MDI 0,02 mg/doseSalbutamol 100 mcg Inhaler, 2 inhalations + Ipratropium 20 mcg Inhalation Aerosol,2 inhalations in the morning (single day).	Drug	Salbutamol + Ipratropium

Primary outcome

FEV1 AUC (0-8h)
Time frame: Baseline, 0 to 8 hours post-dose at treatment day
Change From Baseline in Forced Expiratory Volume in one second (FEV1) Area Under the Curve (AUC) 0-8h. 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.

14 secondary outcomes

FEV1 AUC (0-4h)
Time frame: Baseline, 0 to 4 hours post-dose at treatment day
FEV1 AUC (4-6h)
Time frame: Baseline, 4 to 6 hours post-dose at treatment day
FEV1 AUC (6-8h)
Time frame: Baseline, 6 to 8 hours post-dose at treatment day
FVC AUC (0-4h)
Time frame: Baseline, 0 to 4 hours post-dose at treatment day
FVC AUC (4-6h)
Time frame: Baseline, 4 to 6 hours post-dose at treatment day
FVC AUC (6-8h)
Time frame: Baseline, 6 to 8 hours post-dose at treatment day
FVC AUC (0-8h)
Time frame: Baseline, 0 to 8 hours post-dose at treatment day
Change From Baseline in FEV1 and FVC within the first 15 minutes after dosing
Time frame: Baseline, 0 to 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, 0 to 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
The Time to Maximum Effect
Time frame: Baseline, 0 to 8 hours post-dose at treatment day
Duration of Bronchodilator Response
Time frame: Baseline, 0 to 8 hours post-dose at treatment day
Evaluation of Safety (physical examination, numbers of adverse reactions and abnormal laboratory values or ECG related to treatment)
Time frame: Baseline, 0 to 24 hours post-dose

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
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.

Ismail Hanta, Professor Doctor principal investigator

Cukurova University Faculty of Medicine, Chest Diseases Department Adana - Turkey

Hakan Gunen, Professor Doctor principal investigator

Sureyyapasa Training and Research Center for Chest Diseases and Thoracic Surgery, Maltepe, Istanbul - Turkey

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 10 inclusion and 21 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: withdrawn, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

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?

The study was withdrawn before enrolling participants, so there are no results.

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 AUC (0-8h) (time frame: Baseline, 0 to 8 hours post-dose at treatment day). 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 NCT04446637.

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 13 Sep 2021.