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Efficacy Study of SYN006 HFA MDI in Asthma Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02162784
Recruitment Status : Completed
First Posted : June 13, 2014
Last Update Posted : June 3, 2015
Sponsor:
Information provided by (Responsible Party):
Intech Biopharm Ltd.

Tracking Information
First Submitted Date  ICMJE June 11, 2014
First Posted Date  ICMJE June 13, 2014
Last Update Posted Date June 3, 2015
Study Start Date  ICMJE February 2013
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
The variation of study medications by the area under curve of FEV1 from 0 to 120 minutes (AUC0-120min ) after inhalation. [ Time Frame: 5, 20, 40, 60, 90, 120 minutes, 4, and 6 hours after the inhalation ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 11, 2014)
  • The change in Forced Expiratory Volume in 1 second (FEV1) of study medication. [ Time Frame: 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. [ Time Frame: 5, 20, 40, 60, 90, 120 minutes, 4, and 6 hours after the inhalation ]
  • The change in Forced Vital Capacity (FVC) of study medication. [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: 5, 20, 40, 60, 90, 120 minutes, 4, and 6 hours after the inhalation ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 11, 2014)
Adverse events, vital signs, abnormal ECG outcome. [ Time Frame: 5, 20, 40, 60, 90, 120 minutes, 4, and 6 hours after the inhalation ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Efficacy Study of SYN006 HFA MDI in Asthma Patients
Official Title  ICMJE An Open-Label, Randomized, Cross-Over Study to Evaluate the Dose Response of SYN006 HFA MDI in Asthma Patients
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:

  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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Asthma
Intervention  ICMJE
  • Drug: Budesonide/Procaterol, 180/10mcg X1
    one puff
    Other Name: Synbitide
  • Drug: Budesonide/procaterol 180/10 mcg X 2
    2 puffs
    Other Name: Synbitide
  • Drug: Albuterol HFA MDI 100mcg X2
    HFA MDI, 100mcg, 2 puffs
    Other Name: Ventolin
Study Arms  ICMJE
  • Experimental: Budesonide/procaterol 180/10mcg X1
    HFA MDI, oral inhalation, 180/10mcg, one puff
    Intervention: Drug: Budesonide/Procaterol, 180/10mcg X1
  • Experimental: Budesonide/Procaterol, 180/10mcg X2
    HFA MDI, oral inhalation, two puffs
    Intervention: Drug: Budesonide/procaterol 180/10 mcg X 2
  • Active Comparator: Albuterol HFA MDI 100 mcg X2
    HFA MDI, oral inhalation, 100mcg, two puffs
    Intervention: Drug: Albuterol HFA MDI 100mcg X2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 2, 2015)
39
Original Estimated Enrollment  ICMJE
 (submitted: June 11, 2014)
40
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02162784
Other Study ID Numbers  ICMJE INTB012
INTB012 ( Other Identifier: Taiwan FDA )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Intech Biopharm Ltd.
Study Sponsor  ICMJE Intech Biopharm Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Intech Biopharm Ltd.
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP