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Efficacy Study of SYN006 HFA MDI in Asthma Patients

Primary Purpose

Asthma

Status

Completed

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

Budesonide/Procaterol, 180/10mcg X1

Budesonide/procaterol 180/10 mcg X 2

Albuterol HFA MDI 100mcg X2

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

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

Moderate Persistent:

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

Sites / Locations

Chung Shan Medical University Hospital
National Taiwan University Hospital
Tri-Service General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Budesonide/procaterol 180/10mcg X1

Budesonide/Procaterol, 180/10mcg X2

Albuterol HFA MDI 100 mcg X2

Arm Description

HFA MDI, oral inhalation, 180/10mcg, one puff

HFA MDI, oral inhalation, two puffs

HFA MDI, oral inhalation, 100mcg, two puffs

Outcomes

Primary Outcome Measures

The variation of study medications by the area under curve of FEV1 from 0 to 120 minutes (AUC0-120min ) after inhalation.

Secondary Outcome Measures

The change in Forced Expiratory Volume in 1 second (FEV1) of study medication.

The change in Peak Expiratory Flow Rate (PEFR) of study medication.

The change in Forced Vital Capacity (FVC) of study medication.

The variation of study medications by the area under curve of PEFR from 0 to 120 minutes (AUC0-120min ) after inhalation.

The variation of study medications by the area under curve of FVC from 0 to 120 minutes (AUC0-120min ) after inhalation.

Full Information

NCT ID

NCT02162784

First Posted

June 11, 2014

Last Updated

June 2, 2015

Sponsor

Intech Biopharm Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02162784

Brief Title

Efficacy Study of SYN006 HFA MDI in Asthma Patients

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

February 2013 (undefined)

Primary Completion Date

August 2014 (Actual)

Study Completion Date

August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Intech Biopharm Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

39 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Budesonide/procaterol 180/10mcg X1

Arm Type

Experimental

Arm Description

HFA MDI, oral inhalation, 180/10mcg, one puff

Arm Title

Budesonide/Procaterol, 180/10mcg X2

Arm Type

Experimental

Arm Description

HFA MDI, oral inhalation, two puffs

Arm Title

Albuterol HFA MDI 100 mcg X2

Arm Type

Active Comparator

Arm Description

HFA MDI, oral inhalation, 100mcg, two puffs

Intervention Type

Drug

Intervention Name(s)

Budesonide/Procaterol, 180/10mcg X1

Other Intervention Name(s)

Synbitide

Intervention Description

one puff

Intervention Type

Drug

Intervention Name(s)

Budesonide/procaterol 180/10 mcg X 2

Other Intervention Name(s)

Synbitide

Intervention Description

2 puffs

Intervention Type

Drug

Intervention Name(s)

Albuterol HFA MDI 100mcg X2

Other Intervention Name(s)

Ventolin

Intervention Description

HFA MDI, 100mcg, 2 puffs

Primary Outcome Measure Information:

Title

The variation of study medications by the area under curve of FEV1 from 0 to 120 minutes (AUC0-120min ) after inhalation.

Time Frame