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

NCT04446637 | Withdrawn Phase 3

• 1 other identifier: NEU-01.19
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

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

Outcome Measures

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.

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

Secondary Outcomes (14)

• FEV1 AUC (0-4h)

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

• FEV1 AUC (4-6h)

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

• FEV1 AUC (6-8h)

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

• FVC AUC (0-4h)

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

• FVC AUC (4-6h)

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

Study Arms (2)

Ipratropium/Levosalbutamol

EXPERIMENTAL

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

Salbutamol + Ipratropium

ACTIVE COMPARATOR

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

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

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

Ipratropium/Levosalbutamol

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 in the morning (single day).

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

Salbutamol + Ipratropium

Eligibility Criteria

• Age: 40 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Neutec Ar-Ge San ve Tic A.Ş: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Ipratropium; Albuterol; Suspensions; Nebulizers and Vaporizers

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Ethanolamines; Amino Alcohols; Alcohols; Amines; Phenethylamines; Ethylamines; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations; Equipment and Supplies

Study Officials

• Ismail Hanta, Professor Doctor

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

  PRINCIPAL INVESTIGATOR

• Hakan Gunen, Professor Doctor

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, single day, noninferiority study

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: June 25, 2020
• Study Start: September 3, 2021
• Primary Completion: September 3, 2022
• Study Completion: September 3, 2022
• Last Updated: September 13, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share