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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04446637
Other study ID # NEU-01.19
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
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
Health authority
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Status Withdrawn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.

Study Design


Related Conditions & MeSH terms


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
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