Recruitment

Recruitment Status
Completed
Estimated Enrollment
40

Inclusion Criteria

Male or female patient aged >= 16 years old
Pre-bronchodilator FEV1 > 60% and < 90% of predicted normal value at enrollment;
Diagnosis of mild to moderate persistent asthma according to GINA with a documented history of at least 6 months duration.
...
Male or female patient aged >= 16 years old
Pre-bronchodilator FEV1 > 60% and < 90% of predicted normal value at enrollment;
Diagnosis of mild to moderate persistent asthma according to GINA with a documented history of at least 6 months duration.
History of FEV1 >=12% and 200 ml increase after inhalation of short-acting beta 2-agonist;
Ability to inhale correctly through MDI inhaler
Written informed consent obtained.

Exclusion Criteria

Patients who received any investigational new drug within the last 3 months at enrollment;
Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study;
Pregnant or lactating females or not able to exclude pregnancy during the study period;
...
Patients who received any investigational new drug within the last 3 months at enrollment;
Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study;
Pregnant or lactating females or not able to exclude pregnancy during the study period;
Abnormal ECG at enrollment;
Current smokers or recent (less than one year) ex-smokers, defined as smoking at least 10 pack/years;
Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients;
Inability to carry out pulmonary function testing;
Hospitalization for asthma during the past 3 months at enrollment;
History or current evidence of heart failure, coronary artery disease, myocardial infarction, severe hypertension, or cardiac arrhythmias;
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;
History of alcohol or drug abuse;
Currently uncontrolled asthma according to GINA guideline;
History of near-fatal asthma and/or admission intensive care unit because of asthma;
Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 3 months at enrollment;
Severe asthma associated with reduced lung function;
Patients who have been previously enrolled in this study.
Percutaneous transluminal coronary angioplasty (PTCA) or coronary artery by-pass graft (CABG) during the previous 6 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

Male or female patient aged >= 16 years old
Pre-bronchodilator FEV1 > 60% and < 90% of predicted normal value at enrollment;
Diagnosis of mild to moderate persistent asthma according to GINA with a documented history of at least 6 months duration.
...
Male or female patient aged >= 16 years old
Pre-bronchodilator FEV1 > 60% and < 90% of predicted normal value at enrollment;
Diagnosis of mild to moderate persistent asthma according to GINA with a documented history of at least 6 months duration.
History of FEV1 >=12% and 200 ml increase after inhalation of short-acting beta 2-agonist;
Ability to inhale correctly through MDI inhaler
Written informed consent obtained.

Exclusion Criteria

Patients who received any investigational new drug within the last 3 months at enrollment;
Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study;
Pregnant or lactating females or not able to exclude pregnancy during the study period;
...
Patients who received any investigational new drug within the last 3 months at enrollment;
Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study;
Pregnant or lactating females or not able to exclude pregnancy during the study period;
Abnormal ECG at enrollment;
Current smokers or recent (less than one year) ex-smokers, defined as smoking at least 10 pack/years;
Allergy, sensitivity or intolerance to study drugs and/or study drug formulation ingredients;
Inability to carry out pulmonary function testing;
Hospitalization for asthma during the past 3 months at enrollment;
History or current evidence of heart failure, coronary artery disease, myocardial infarction, severe hypertension, or cardiac arrhythmias;
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;
History of alcohol or drug abuse;
Currently uncontrolled asthma according to GINA guideline;
History of near-fatal asthma and/or admission intensive care unit because of asthma;
Evidence of severe asthma exacerbation or symptomatic infection of the airways in the previous 3 months at enrollment;
Severe asthma associated with reduced lung function;
Patients who have been previously enrolled in this study.
Percutaneous transluminal coronary angioplasty (PTCA) or coronary artery by-pass graft (CABG) during the previous 6 months at enrollment;

Tracking Information

NCT #
NCT02162784
Collaborators
Not Provided
Investigators
Not Provided
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