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Efficacy Study of SYN006 HFA MDI in Asthma Patients

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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.

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.

Condition or disease Intervention/treatment Phase
Asthma Drug: Budesonide/Procaterol, 180/10mcg X1 Drug: Budesonide/procaterol 180/10 mcg X 2 Drug: Albuterol HFA MDI 100mcg X2 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Randomized, Cross-Over Study to Evaluate the Dose Response of SYN006 HFA MDI in Asthma Patients
Study Start Date : February 2013
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: Budesonide/procaterol 180/10mcg X1
HFA MDI, oral inhalation, 180/10mcg, one puff
Drug: Budesonide/Procaterol, 180/10mcg X1
one puff
Other Name: Synbitide

Experimental: Budesonide/Procaterol, 180/10mcg X2
HFA MDI, oral inhalation, two puffs
Drug: Budesonide/procaterol 180/10 mcg X 2
2 puffs
Other Name: 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 Name: Ventolin




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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. 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 ]

Other Outcome Measures:
  1. Adverse events, vital signs, abnormal ECG outcome. [ Time Frame: 5, 20, 40, 60, 90, 120 minutes, 4, and 6 hours after the inhalation ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02162784


Locations
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Taiwan
Chung Shan Medical University Hospital
TaiChung, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Sponsors and Collaborators
Intech Biopharm Ltd.

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Responsible Party: Intech Biopharm Ltd.
ClinicalTrials.gov Identifier: NCT02162784     History of Changes
Other Study ID Numbers: INTB012
INTB012 ( Other Identifier: Taiwan FDA )
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: June 3, 2015
Last Verified: June 2015
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Albuterol
Procaterol
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action