Efficacy Study of SYN006 HFA MDI in Asthma Patients

NCT02162784 | Completed Phase 2 DMC

• 1 other identifier: INTB012
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 3

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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 Outcomes (1)

• Adverse events, vital signs, abnormal ECG outcome.

  5, 20, 40, 60, 90, 120 minutes, 4, and 6 hours after the inhalation

Study Arms (3)

Budesonide/procaterol 180/10mcg X1

EXPERIMENTAL

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

Drug: Budesonide/Procaterol, 180/10mcg X1

Budesonide/Procaterol, 180/10mcg X2

EXPERIMENTAL

HFA MDI, oral inhalation, two puffs

Drug: Budesonide/procaterol 180/10 mcg X 2

Albuterol HFA MDI 100 mcg X2

ACTIVE COMPARATOR

HFA MDI, oral inhalation, 100mcg, two puffs

Drug: Albuterol HFA MDI 100mcg X2

Interventions

Budesonide/Procaterol, 180/10mcg X1 DRUG

one puff

Also known as: Synbitide

Budesonide/procaterol 180/10mcg X1

Budesonide/procaterol 180/10 mcg X 2 DRUG

2 puffs

Also known as: Synbitide

Budesonide/Procaterol, 180/10mcg X2

Albuterol HFA MDI 100mcg X2 DRUG

HFA MDI, 100mcg, 2 puffs

Also known as: Ventolin

Albuterol HFA MDI 100 mcg X2

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Intech Biopharm Ltd.: lead

Study Sites (3)

Chung Shan Medical University Hospital

Taichung, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Tri-Service General Hospital

Taipei, Taiwan

Location

MeSH Terms

Conditions

Asthma

Interventions

Budesonide; Procaterol; Albuterol

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Hydroxyquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Phenethylamines; Ethylamines

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 13, 2014
• Study Start: February 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: June 3, 2015

Record last verified: 2015-06

Locations

TW (3)