Efficacy Study of SYN006 HFA MDI in Asthma Patients

An Open-Label, Randomized, Cross-Over Study to Evaluate the Dose Response of SYN006 HFA MDI in Asthma Patients

The objective of the study is to evaluate the dose response of SYN006 HFA MDI, which is a combination drug product of budesonide and procaterol hydrochloride, in asthma patients. Patients with mild to moderate asthma will be recruited. There will be two study medication administered in this study. The investigational medication is SYN006 (Budesonide/Procaterol hydrochloride, 180 mcg/10 mcg per inhalation) and the active comparative medication is Ventolin (Salbutamol sulfate 100 mcg per inhalation). The study medication will be administered by oral inhalation with the supervision of the investigator or a qualified staff.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Budesonide/Procaterol, 180/10mcg X1; Drug: Budesonide/procaterol 180/10 mcg X 2; Drug: Albuterol HFA MDI 100mcg X2

Detailed 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 schedule:

1. A-B-C,
2. B-A-C,
3. C-A-B,
4. C-B-A,
5. A-C-B,
6. 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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Phase 2

Contacts and Locations

Study Locations

• Taiwan
  • TaiChung, Taiwan
    • Chung Shan Medical University Hospital
  • Taipei, Taiwan
    • Tri-Service General Hospital
  • Taipei, Taiwan
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Mild Persistent:

1. Symptoms more than once a week but less than once a day
2. Nocturnal symptoms more than twice a month
3. Exacerbations may affect activity and sleep
4. FEV1 or PEF >= 80% predicted
5. PEF or FEV1 variability < 20 - 30%

Moderate Persistent:

1. Symptoms daily
2. Nocturnal symptoms more than once a week
3. Exacerbations may affect activity and sleep
4. Daily use of inhaled short-acting beta2-agonist
5. FEV1 or PEF > 60% - < 80% predicted
6. PEF or FEV1 variability > 30%

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Budesonide/procaterol 180/10mcg X1; HFA MDI, oral inhalation, 180/10mcg, one puff	Drug: Budesonide/Procaterol, 180/10mcg X1; one puff; Other Names: Synbitide
Experimental: Budesonide/Procaterol, 180/10mcg X2; HFA MDI, oral inhalation, two puffs	Drug: Budesonide/procaterol 180/10 mcg X 2; 2 puffs; Other Names: Synbitide
Active Comparator: Albuterol HFA MDI 100 mcg X2; HFA MDI, oral inhalation, 100mcg, two puffs	Drug: Albuterol HFA MDI 100mcg X2; HFA MDI, 100mcg, 2 puffs; Other Names: Ventolin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The variation of study medications by the area under curve of FEV1 from 0 to 120 minutes (AUC0-120min ) after inhalation.	5, 20, 40, 60, 90, 120 minutes, 4, and 6 hours after the inhalation

Secondary Outcome Measures

Outcome Measure	Time Frame
The change in Forced Expiratory Volume in 1 second (FEV1) of study medication.	5, 20, 40, 60, 90, 120 minutes, 4, and 6 hours after the inhalation
The change in Peak Expiratory Flow Rate (PEFR) of study medication.	5, 20, 40, 60, 90, 120 minutes, 4, and 6 hours after the inhalation
The change in Forced Vital Capacity (FVC) of study medication.	5, 20, 40, 60, 90, 120 minutes, 4, and 6 hours after the inhalation
The variation of study medications by the area under curve of PEFR from 0 to 120 minutes (AUC0-120min ) after inhalation.	5, 20, 40, 60, 90, 120 minutes, 4, and 6 hours after the inhalation
The variation of study medications by the area under curve of FVC from 0 to 120 minutes (AUC0-120min ) after inhalation.	5, 20, 40, 60, 90, 120 minutes, 4, and 6 hours after the inhalation

Other Outcome Measures

Outcome Measure	Time Frame
Adverse events, vital signs, abnormal ECG outcome.	5, 20, 40, 60, 90, 120 minutes, 4, and 6 hours after the inhalation

Collaborators and Investigators

• Sponsor: Intech Biopharm Ltd.

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: June 11, 2014
• First Submitted That Met QC Criteria: June 11, 2014
• First Posted (Estimate): June 13, 2014

Study Record Updates

• Last Update Posted (Estimate): June 3, 2015
• Last Update Submitted That Met QC Criteria: June 2, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Reproductive Control Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Tocolytic Agents; Sympathomimetics; Budesonide; Albuterol; Procaterol
• Other Study ID Numbers: INTB012 (Other Identifier: Taiwan FDA)