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Efficacy of Once-daily Budesonide/Formoterol Turbuhaler 4.5/160 µg in Step Down Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Budesonide/formoterol (160/4.5 μg/d)
Budesonide (400μg/d)
Sponsored by
Hat Yai Medical Education Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Asthmatic patients who have well controlled asthma at least 12 weeks with using budesonide/formoterol (160/4.5 μg/d) twice daily
  • Age more than 18 year-old
  • Patients who able to do spirometry without contraindication
  • History smoking less than 10 pack-years

Exclusion Criteria:

  • History of using systemic steroid previous 4 week and respiratory infection
  • History of pulmonary tuberculosis with residual lung lesion by chest radiograph
  • recent serious medical condition such as myocardial infarction, stroke, pneumonia etc.

Sites / Locations

  • Narongwit Nakwan

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Once-daily budesonide/formoterol (160/4.5 μg/d)

Twice-daily Budesonide (200μg)

Arm Description

once-daily budesonide/formoterol (160/4.5 μg/d)

twice-daily Budesonide (400μg/d)

Outcomes

Primary Outcome Measures

Change from baseline in Asthma Control Questionnaire (ACQ) score
Asthma Control Questionnaire (ACQ) that is 6 items of self-administered and 1 item of FEV1%. It has 7-point scale (=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%). Scores range between 0 (totally controlled) and 6 (severely uncontrolled).
Change from baseline in Asthma Controlled Test (ACT) score
1. Asthma Controlled Test (ACT); grouped in five domains; frequency of shortness of breath, general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled). The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma

Secondary Outcome Measures

Change from baseline in Peak expiratory flow (PEF)
The mean value of PEF (Litre per minute) for baseline, week 4, 8 and 12 was analysed.
Change from baseline in Forced Expiratory Volume in One Second (FEV1)
The mean value for baseline and week 12 was analysed.
Percentage of participants who were categorized from asthma controlled assessment following GINA guideline

Full Information

First Posted
January 20, 2016
Last Updated
April 14, 2017
Sponsor
Hat Yai Medical Education Center
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1. Study Identification

Unique Protocol Identification Number
NCT02725242
Brief Title
Efficacy of Once-daily Budesonide/Formoterol Turbuhaler 4.5/160 µg in Step Down Asthma
Official Title
A 12-week, Randomized, Parallel-group, Phase III Study Comparing the Efficacy of Once-daily Budesonide/Formoterol Turbuhaler (160/4.5 μg/d) and Twice-daily Budesonide Giona Easyhaler (400 μg/d) During Step-down Period in Well Controlled Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
March 2016 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hat Yai Medical Education Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the efficacy of Once-daily Budesonide/formoterol Turbuhaler 160/4.5 µg/d in the period of step down in well controlled asthmatic patient.
Detailed Description
The study will measure the efficacy of once daily low dose ICS/ LABA in well controlled asthmatic patient comparing with low dose ICS in step down circumstance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
77 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Once-daily budesonide/formoterol (160/4.5 μg/d)
Arm Type
Experimental
Arm Description
once-daily budesonide/formoterol (160/4.5 μg/d)
Arm Title
Twice-daily Budesonide (200μg)
Arm Type
Active Comparator
Arm Description
twice-daily Budesonide (400μg/d)
Intervention Type
Drug
Intervention Name(s)
Budesonide/formoterol (160/4.5 μg/d)
Other Intervention Name(s)
Symbicort Turbuhaler (160/4.5 μg/d)
Intervention Description
After the patients who have all criteria, they will be randomization to take Budesonide/formoterol (160/4.5 μg/d)
Intervention Type
Drug
Intervention Name(s)
Budesonide (400μg/d)
Other Intervention Name(s)
Giona Easyhaler
Intervention Description
After the patients who have all criteria, they will be randomization to take Budesonide (200 ug) twice daily
Primary Outcome Measure Information:
Title
Change from baseline in Asthma Control Questionnaire (ACQ) score
Description
Asthma Control Questionnaire (ACQ) that is 6 items of self-administered and 1 item of FEV1%. It has 7-point scale (=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%). Scores range between 0 (totally controlled) and 6 (severely uncontrolled).
Time Frame
Baseline and week 12
Title
Change from baseline in Asthma Controlled Test (ACT) score
Description
1. Asthma Controlled Test (ACT); grouped in five domains; frequency of shortness of breath, general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled). The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma
Time Frame
Baseline, week 4, week 8 and week 12
Secondary Outcome Measure Information:
Title
Change from baseline in Peak expiratory flow (PEF)
Description
The mean value of PEF (Litre per minute) for baseline, week 4, 8 and 12 was analysed.
Time Frame
Baseline, week 4, week 8 and week 12
Title
Change from baseline in Forced Expiratory Volume in One Second (FEV1)
Description
The mean value for baseline and week 12 was analysed.
Time Frame
Baseline and week 12
Title
Percentage of participants who were categorized from asthma controlled assessment following GINA guideline
Time Frame
Baseline, week 4, week 8 and week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Asthmatic patients who have well controlled asthma at least 12 weeks with using budesonide/formoterol (160/4.5 μg/d) twice daily Age more than 18 year-old Patients who able to do spirometry without contraindication History smoking less than 10 pack-years Exclusion Criteria: History of using systemic steroid previous 4 week and respiratory infection History of pulmonary tuberculosis with residual lung lesion by chest radiograph recent serious medical condition such as myocardial infarction, stroke, pneumonia etc.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Narongwit Nakwan, M.D.
Organizational Affiliation
Hatyai Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Narongwit Nakwan
City
Hatyai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Efficacy of Once-daily Budesonide/Formoterol Turbuhaler 4.5/160 µg in Step Down Asthma

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