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AsthmaPhase 2NCT02162784

Efficacy Study of SYN006 HFA MDI in Asthma Patients

A Phase 2 study testing Budesonide/Procaterol, 180/10mcg X1, Budesonide/procaterol 180/10 mcg X 2 and Albuterol HFA MDI 100mcg X2 in people with Asthma, run by Intech Biopharm Ltd. at 3 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 16 years and older
Conditions the study is for
Asthma
What is being tested?
Budesonide/Procaterol, 180/10mcg X1, Budesonide/procaterol 180/10 mcg X 2 and Albuterol HFA MDI 100mcg X2
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
39 participants
Where
3 sitesTaiwan
Study dates
Feb 2013to Aug 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 16 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
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  • 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%

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

3 sites in 1 country.

Taiwan3 sites

  • Chung Shan Medical University Hospital

    Taichung

  • National Taiwan University Hospital

    Taipei

  • Tri-Service General Hospital

    Taipei

Other trials in Taiwan

About this study

Official title: 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.

Read the 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.
Conditions
Asthma
Being tested
Budesonide/Procaterol, 180/10mcg X1, Budesonide/procaterol 180/10 mcg X 2, Albuterol HFA MDI 100mcg X2
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Budesonide/Procaterol, 180/10mcg X1Drug

    Also called Synbitide

    one puff

  • Budesonide/procaterol 180/10 mcg X 2Drug

    Also called Synbitide

    2 puffs

  • Albuterol HFA MDI 100mcg X2Drug

    Also called Ventolin

    HFA MDI, 100mcg, 2 puffs

Study groups in NCT02162784
Study groupRoleWhat they receive
Budesonide/procaterol 180/10mcg X1ExperimentalHFA MDI, oral inhalation, 180/10mcg, one puff
Receives: Drug: Budesonide/Procaterol, 180/10mcg X1
Budesonide/Procaterol, 180/10mcg X2ExperimentalHFA MDI, oral inhalation, two puffs
Receives: Drug: Budesonide/procaterol 180/10 mcg X 2
Albuterol HFA MDI 100 mcg X2Active comparatorHFA MDI, oral inhalation, 100mcg, two puffs
Receives: Drug: Albuterol HFA MDI 100mcg X2

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (5)

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

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

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

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

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

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

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

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

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

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2014 (estimated)
  2. Study startFeb 2013
  3. Primary completionAug 2014
  4. Study completionAug 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
39 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02162784
Sponsor's protocol ID
INTB012
Other IDs
INTB012
Status last verified
Jun 2015
First submitted
11 Jun 2014
Last updated
3 Jun 2015
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Budesonide/Procaterol, 180/10mcg X1, Budesonide/procaterol 180/10 mcg X 2 and Albuterol HFA MDI 100mcg X2 in people with Asthma, run by Intech Biopharm Ltd. at 3 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02162784.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2015.

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