Efficacy Study of SYN006 HFA MDI in Asthma Patients

June 2, 2015 updated by: Intech Biopharm Ltd.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
39

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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.
Time Frame: 5, 20, 40, 60, 90, 120 minutes, 4, and 6 hours after the inhalation
5, 20, 40, 60, 90, 120 minutes, 4, and 6 hours after the inhalation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
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
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
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
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
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
5, 20, 40, 60, 90, 120 minutes, 4, and 6 hours after the inhalation

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
Adverse events, vital signs, abnormal ECG outcome.
Time Frame: 5, 20, 40, 60, 90, 120 minutes, 4, and 6 hours after the inhalation
5, 20, 40, 60, 90, 120 minutes, 4, and 6 hours after the inhalation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Intech Biopharm Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 11, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 13, 2014

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2015

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2015

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • INTB012 (Other Identifier: Taiwan FDA)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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