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

NCT ID: NCT04446637

Last Updated: 2021-09-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-03
• Study Completion Date: 2022-09-03

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ipratropium/Levosalbutamol

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

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Salbutamol + Ipratropium

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

Group Type: ACTIVE_COMPARATOR

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

Intervention Type: DRUG

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

Interventions

Ipratropium/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)

Intervention Type: DRUG

Salbutamol 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).

Intervention Type: DRUG

Other Intervention Names

IPRALEV 20 mcg/50 mcg Aerosol Inhalation, Suspension; VENTOLİN İnhaler 100 mcg + ATROVENT N MDI 0,02 mg/dose

Eligibility Criteria

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

• 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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Neutec Ar-Ge San ve Tic A.Ş

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ismail Hanta, Professor Doctor

Role: PRINCIPAL_INVESTIGATOR

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

Hakan Gunen, Professor Doctor

Role: PRINCIPAL_INVESTIGATOR

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

Other Identifiers

NEU-01.19

Identifier Type: -

Identifier Source: org_study_id