Efficacy Study of SYN006 HFA MDI in Asthma Patients
Last updated on April 2022Recruitment
- Recruitment Status
- Completed
- Estimated Enrollment
- 40
Inclusion Criteria
- Diagnosis of mild to moderate persistent asthma according to GINA with a documented history of at least 6 months duration.
- Ability to inhale correctly through MDI inhaler
- Male or female patient aged >= 16 years old
- ...
- Diagnosis of mild to moderate persistent asthma according to GINA with a documented history of at least 6 months duration.
- Ability to inhale correctly through MDI inhaler
- Male or female patient aged >= 16 years old
- Written informed consent obtained.
- Pre-bronchodilator FEV1 > 60% and < 90% of predicted normal value at enrollment;
- History of FEV1 >=12% and 200 ml increase after inhalation of short-acting beta 2-agonist;
Exclusion Criteria
- Clinically significant or unstable concurrent diseases: uncontrolled hyperthyroidism, significant hepatic impairment, poorly controlled pulmonary disease (tuberculosis, active mycotic infection of the lung), gastrointestinal (e.g., active peptic ulcer), neurological or haematological autoimmune diseases;
- Severe asthma associated with reduced lung function;
- Currently uncontrolled asthma according to GINA guideline;
- ...
- Clinically significant or unstable concurrent diseases: uncontrolled hyperthyroidism, significant hepatic impairment, poorly controlled pulmonary disease (tuberculosis, active mycotic infection of the lung), gastrointestinal (e.g., active peptic ulcer), neurological or haematological autoimmune diseases;
- Severe asthma associated with reduced lung function;
- Currently uncontrolled asthma according to GINA guideline;
- Percutaneous transluminal coronary angioplasty (PTCA) or coronary artery by-pass graft (CABG) during the previous 6 months at enrollment;
- Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study;
- Inability to carry out pulmonary function testing;
- Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients;
- History of alcohol or drug abuse;
- History or current evidence of heart failure, coronary artery disease, myocardial infarction, severe hypertension, or cardiac arrhythmias;
- Patients who have been previously enrolled in this study.
- History of near-fatal asthma and/or admission intensive care unit because of asthma;
- Patients who received any investigational new drug within the last 3 months at enrollment;
- Pregnant or lactating females or not able to exclude pregnancy during the study period;
- Current smokers or recent (less than one year) ex-smokers, defined as smoking at least 10 pack/years;
- Abnormal ECG at enrollment;
- Hospitalization for asthma during the past 3 months at enrollment;
- Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 3 months at enrollment;
Summary
- Conditions
- Asthma
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Masking: None (Open Label)
- Primary Purpose: Treatment
Participation Requirements
- Age
- Between 16 years and 125 years
- Gender
- Both males and females
Description
Three treatments will be administered in a patient: A. Two inhalations of Ventolin 100 mcg, B. One inhalation of SYN006 180/10 mcg, C. Two inhalations of SYN006 180/10 mcg. Patients will be received the study treatment according to one of the six treatment sequences according to the randomization sc...
Three treatments will be administered in a patient: A. Two inhalations of Ventolin 100 mcg, B. One inhalation of SYN006 180/10 mcg, C. Two inhalations of SYN006 180/10 mcg. Patients will be received the study treatment according to one of the six treatment sequences according to the randomization schedule: A-B-C, B-A-C, C-A-B, C-B-A, A-C-B, B-C-A. The efficacy endpoint is The change in Forced Expiratory Volume in 1 second (FEV1) within 6 hours. The change in Peak Expiratory Flow Rate (PEFR) within 6 hours. The change in Force Vital Capacity (FVC) within 6 hours.
Inclusion Criteria
- Diagnosis of mild to moderate persistent asthma according to GINA with a documented history of at least 6 months duration.
- Ability to inhale correctly through MDI inhaler
- Male or female patient aged >= 16 years old
- ...
- Diagnosis of mild to moderate persistent asthma according to GINA with a documented history of at least 6 months duration.
- Ability to inhale correctly through MDI inhaler
- Male or female patient aged >= 16 years old
- Written informed consent obtained.
- Pre-bronchodilator FEV1 > 60% and < 90% of predicted normal value at enrollment;
- History of FEV1 >=12% and 200 ml increase after inhalation of short-acting beta 2-agonist;
Exclusion Criteria
- Clinically significant or unstable concurrent diseases: uncontrolled hyperthyroidism, significant hepatic impairment, poorly controlled pulmonary disease (tuberculosis, active mycotic infection of the lung), gastrointestinal (e.g., active peptic ulcer), neurological or haematological autoimmune diseases;
- Severe asthma associated with reduced lung function;
- Currently uncontrolled asthma according to GINA guideline;
- ...
- Clinically significant or unstable concurrent diseases: uncontrolled hyperthyroidism, significant hepatic impairment, poorly controlled pulmonary disease (tuberculosis, active mycotic infection of the lung), gastrointestinal (e.g., active peptic ulcer), neurological or haematological autoimmune diseases;
- Severe asthma associated with reduced lung function;
- Currently uncontrolled asthma according to GINA guideline;
- Percutaneous transluminal coronary angioplasty (PTCA) or coronary artery by-pass graft (CABG) during the previous 6 months at enrollment;
- Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study;
- Inability to carry out pulmonary function testing;
- Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients;
- History of alcohol or drug abuse;
- History or current evidence of heart failure, coronary artery disease, myocardial infarction, severe hypertension, or cardiac arrhythmias;
- Patients who have been previously enrolled in this study.
- History of near-fatal asthma and/or admission intensive care unit because of asthma;
- Patients who received any investigational new drug within the last 3 months at enrollment;
- Pregnant or lactating females or not able to exclude pregnancy during the study period;
- Current smokers or recent (less than one year) ex-smokers, defined as smoking at least 10 pack/years;
- Abnormal ECG at enrollment;
- Hospitalization for asthma during the past 3 months at enrollment;
- Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 3 months at enrollment;
Tracking Information
- NCT #
- NCT02162784
- Collaborators
- Not Provided
- Investigators
- Not Provided