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

Chronic Obstructive Pulmonary Disease Clinical Trial

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).

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04446637
• Other study ID #: NEU-01.19
• Status: Withdrawn
• Phase: Phase 3
• Start date: September 3, 2021
• Est. completion date: September 3, 2022

Study information

• Verified date: September 2021
• Source: Neutec Ar-Ge San ve Tic A.S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 moderate-severe-very severe COPD.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 3, 2022
• Est. primary completion date: September 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 120 Years

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• 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)
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Neutec Ar-Ge San ve Tic A.S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline, 0 to 4 hours post-dose at treatment day
Secondary	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.	Baseline, 4 to 6 hours post-dose at treatment day
Secondary	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.	Baseline, 6 to 8 hours post-dose at treatment day
Secondary	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.	Baseline, 0 to 4 hours post-dose at treatment day
Secondary	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.	Baseline, 4 to 6 hours post-dose at treatment day
Secondary	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.	Baseline, 6 to 8 hours post-dose at treatment day
Secondary	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.	Baseline, 0 to 8 hours post-dose at treatment day
Secondary	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.	Baseline, 0 to 15 minutes post-dose at treatment day
Secondary	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.	Baseline, 0 to 2 hours post-dose at treatment day
Secondary	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.	Baseline, 0 to 8 hours post-dose at treatment day
Secondary	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.	Baseline, 0 to 8 hours post-dose at treatment day
Secondary	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.	Baseline, 0 to 8 hours post-dose at treatment day
Secondary	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.	Baseline, 0 to 8 hours post-dose at treatment day
Secondary	Evaluation of Safety (physical examination, numbers of adverse reactions and abnormal laboratory values or ECG related to treatment)		Baseline, 0 to 24 hours post-dose