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).
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 |
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.
Status | Withdrawn |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. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Neutec Ar-Ge San ve Tic A.S |
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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05102305 -
A Multi-center,Prospective, OS to Evaluate the Effectiveness of 'NAC' Nebulizer Therapy in COPD (NEWEST)
|
||
Completed |
NCT01867762 -
An Effectiveness and Safety Study of Inhaled JNJ 49095397 (RV568) in Patients With Moderate to Severe Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
Recruiting |
NCT05562037 -
Stepped Care vs Center-based Cardiopulmonary Rehabilitation for Older Frail Adults Living in Rural MA
|
N/A | |
Terminated |
NCT04921332 -
Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD
|
N/A | |
Completed |
NCT03089515 -
Small Airway Chronic Obstructive Disease Syndrome Following Exposure to WTC Dust
|
N/A | |
Completed |
NCT02787863 -
Clinical and Immunological Efficiency of Bacterial Vaccines at Adult Patients With Bronchopulmonary Pathology
|
Phase 4 | |
Recruiting |
NCT05552833 -
Pulmonary Adaptive Responses to HIIT in COPD
|
N/A | |
Recruiting |
NCT05835492 -
A Pragmatic Real-world Multicentre Observational Research Study to Explore the Clinical and Health Economic Impact of myCOPD
|
||
Recruiting |
NCT05631132 -
May Noninvasive Mechanical Ventilation (NIV) and/or Continuous Positive Airway Pressure (CPAP) Increase the Bronchoalveolar Lavage (BAL) Salvage in Patients With Pulmonary Diseases?
|
N/A | |
Completed |
NCT03244137 -
Effects of Pulmonary Rehabilitation on Cognitive Function in Patients With Severe to Very Severe Chronic Obstructive Pulmonary Disease
|
||
Not yet recruiting |
NCT03282526 -
Volume Parameters vs Flow Parameters in Assessment of Reversibility in Chronic Obstructive Pulmonary Disease
|
N/A | |
Completed |
NCT02546700 -
A Study to Evaluate Safety and Efficacy of Lebrikizumab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 2 | |
Completed |
NCT04535986 -
A Phase 3 Clinical Trial to Evaluate the Safety and Efficacy of Ensifentrine in Patients With COPD
|
Phase 3 | |
Recruiting |
NCT05865184 -
Evaluation of Home-based Sensor System to Detect Health Decompensation in Elderly Patients With History of CHF or COPD
|
||
Completed |
NCT03295474 -
Telemonitoring in Pulmonary Rehabilitation: Feasibility and Acceptability of a Remote Pulse Oxymetry System.
|
||
Completed |
NCT03256695 -
Evaluate the Relationship Between Use of Albuterol Multidose Dry Powder Inhaler With an eModule (eMDPI) and Exacerbations in Participants With Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 3 | |
Withdrawn |
NCT04042168 -
Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 4 | |
Completed |
NCT03414541 -
Safety And Efficacy Study Of Orally Administered DS102 In Patients With Chronic Obstructive Pulmonary Disease
|
Phase 2 | |
Completed |
NCT02552160 -
DETECT-Register DocumEnTation and Evaluation of a COPD Combination Therapy
|
||
Recruiting |
NCT05306743 -
PRagmatic EVAluation of a Quality Improvement Program for People Living With Modifiable High-risk COPD.
|
N/A |