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WithdrawnNCT04446637Updated Sep 13, 2021

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 interventional study of 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 Chronic Obstructive Pulmonary Disease, sponsored by Neutec Ar-Ge San ve Tic A.Ş. Withdrawn. Open to participants aged 40 Years to 120 Years. Per ClinicalTrials.gov, last updated 2021-09-13.

Sponsored by Neutec Ar-Ge San ve Tic A.Ş · Phase 3, Interventional, and Treatment

Why this study was withdrawn
administrative decision
Phase
Phase 3
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
40 Years to 120 Years
Sex
All
01

Study 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 moderate-severe-very severe COPD.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • COPD, ipratropium, levosalbutamol, levalbuterol, salbutamol, albuterol, MDI
03

In context

Lung Diseases

3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.

Browse Lung Diseases studies →

Lead sponsor

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.

04

Who can participate

Ages eligible
40 Years to 120 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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
  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
0 participants (actual)

Study arms

  • Experimental
    Ipratropium/Levosalbutamol

    Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination (2 inhalations) via pMDI

    Drug: Ipratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination (2 inhalations) via pMDI

  • Active comparator
    Salbutamol + Ipratropium

    Salbutamol 100 mcg Inhaler (2 inhalations) + Ipratropium 20 mcg Inhalation Aerosol (2 inhalations) Free Combination via MDI

    Drug: Salbutamol 100 mcg Inhaler (2 inhalations) + Ipratropium 20 mcg Inhalation Aerosol (2 inhalations) Free Combination via MDI

Interventions

  • DrugIpratropium/Levosalbutamol 20/50 mcg Fixed Dose Combination (2 inhalations) via pMDI

    Ipratropium/Levosalbutamol 20 mcg/50 mcg Aerosol Inhalation, Suspension 2 inhalations in the morning (single day)

    Also known as: IPRALEV 20 mcg/50 mcg Aerosol Inhalation, Suspension

  • DrugSalbutamol 100 mcg Inhaler (2 inhalations) + Ipratropium 20 mcg Inhalation Aerosol (2 inhalations) Free Combination via MDI

    Salbutamol 100 mcg Inhaler, 2 inhalations + Ipratropium 20 mcg Inhalation Aerosol,2 inhalations in the morning (single day).

    Also known as: VENTOLİN İnhaler 100 mcg + ATROVENT N MDI 0,02 mg/dose

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Baseline, 0 to 8 hours post-dose at treatment day

Secondary outcomes

  1. 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.

    Time frame: Baseline, 0 to 4 hours post-dose at treatment day

  2. 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.

    Time frame: Baseline, 4 to 6 hours post-dose at treatment day

  3. 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.

    Time frame: Baseline, 6 to 8 hours post-dose at treatment day

  4. 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.

    Time frame: Baseline, 0 to 4 hours post-dose at treatment day

  5. 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.

    Time frame: Baseline, 4 to 6 hours post-dose at treatment day

  6. 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.

    Time frame: Baseline, 6 to 8 hours post-dose at treatment day

  7. 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.

    Time frame: Baseline, 0 to 8 hours post-dose at treatment day

  8. 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.

    Time frame: Baseline, 0 to 15 minutes post-dose at treatment day

  9. 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.

    Time frame: Baseline, 0 to 2 hours post-dose at treatment day

  10. 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.

    Time frame: Baseline, 0 to 8 hours post-dose at treatment day

  11. 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.

    Time frame: Baseline, 0 to 8 hours post-dose at treatment day

  12. 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.

    Time frame: Baseline, 0 to 8 hours post-dose at treatment day

  13. 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.

    Time frame: Baseline, 0 to 8 hours post-dose at treatment day

  14. 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

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04446637
Lead sponsor
Neutec Ar-Ge San ve Tic A.Ş
Responsible party
Sponsor
First posted
Jun 25, 2020
Start date
Sep 3, 2021 (estimated)
Primary completion
Sep 3, 2022 (estimated)
Completion
Sep 3, 2022 (estimated)
Last update
Sep 13, 2021

Study contacts

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

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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