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As-needed Budesonide/Formoterol Turbuhaler in Stepping Down Period

Primary Purpose

Asthma

Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Budesonide/Formoterol Fumarate 160 MCG-4.5 MCG Inhalation Powder
Budesonide 200Mcg Inhalation Powder
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 focused on measuring asthma, allergy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Patients who have been diagnosed as asthma at least 6 months.
  2. Patients who have well controlled asthma by ACT > 23 and ACQ-7 < 0.75 at least 12 weeks with using budesonide/formoterol (160/4.5 μg/d) twice daily
  3. Patient who not be taking oral bronchodilator such as montelukast, theophylline, doxophylline but accept for taking anti histamine and intranasal steroid.
  4. Patients who able to do spirometry without contraindication.

Exclusion Criteria:

  1. History of using systemic steroid previous 12 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.
  2. History smoking less than 10 pack-years or be smoking
  3. History of asthma exacabation previous 12 week

Sites / Locations

  • Hatyai Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

As-needed Budesonide/Formoterol

Budesonide

Arm Description

As-needed Budesonide/Formoterol (160/4.5 ug)

Budesonide (200 ug) twice daily

Outcomes

Primary Outcome Measures

Time to First moderate/severe asthma exacerbation rate or loss of asthma controlled
Duration after the patients who has been randomised to developed asthma exacerbation or loss of asthma control that evaluation by Asthma Controlled Test (ACT)
Time to First moderate/severe asthma exacarbation rate
Duration after randomisation until the patients will develop asthma exacerbation.
Time to First loss of asthma controlled
Duration after randomisation until the patients will have a loss of asthma control evaluating by Asthma Controlled Test (ACT)
The ratio of asthma controlled to total number of participants
The ratio of participants who will be classified for asthma controlled to total number of participants by ACT score

Secondary Outcome Measures

Change in lung function: FEV1%predicted
Change from baseline in FEV1%predicted
Change in blood eosinophil count
The change of absoluted eosinophil count after step down medication
Change in FENO
The change of FENO after step down medication
Mean dose of inhaled steroid
The amount of inhaled steroid dose throughout the study
Change in lung function: Peak expiratory flow
Change from baseline in Peak expiratory flow

Full Information

First Posted
December 20, 2019
Last Updated
August 2, 2022
Sponsor
Hat Yai Medical Education Center
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1. Study Identification

Unique Protocol Identification Number
NCT04215848
Brief Title
As-needed Budesonide/Formoterol Turbuhaler in Stepping Down Period
Official Title
A Pilot Study of Efficacy of As-needed Budesonide/Formoterol Turbuhaler During Stepping Down Period From Step-3 in Adult Patients With Adequately Controlled Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
April 1, 2020 (Actual)
Primary Completion Date
October 10, 2021 (Actual)
Study Completion Date
May 30, 2022 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will evaluate the efficacy of as-needed Budesonide/formoterol Turbuhaler 160/4.5 µg/d in the period of step down in well controlled asthmatic patient comparing with standard maintenance therapy in step-2 management in asthma guildeline which is low dose inhaled corticosteroid.
Detailed Description
The study will measure the efficacy of as-needed 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
Keywords
asthma, allergy

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
As-needed Budesonide/Formoterol
Arm Type
Experimental
Arm Description
As-needed Budesonide/Formoterol (160/4.5 ug)
Arm Title
Budesonide
Arm Type
Active Comparator
Arm Description
Budesonide (200 ug) twice daily
Intervention Type
Drug
Intervention Name(s)
Budesonide/Formoterol Fumarate 160 MCG-4.5 MCG Inhalation Powder
Other Intervention Name(s)
Symbicort Turbuhaler (160/4.5 ug)
Intervention Description
After the patients who have all criteria, they will be randomized to take Budesonide/formoterol (160/4.5 μg/d) as need when they have symptoms.
Intervention Type
Drug
Intervention Name(s)
Budesonide 200Mcg Inhalation Powder
Other Intervention Name(s)
Pulmicort Turbuhaler (200 ug)
Intervention Description
After the patients who have all criteria, they will be randomized to take Budesonide (200 μg) twice daily
Primary Outcome Measure Information:
Title
Time to First moderate/severe asthma exacerbation rate or loss of asthma controlled
Description
Duration after the patients who has been randomised to developed asthma exacerbation or loss of asthma control that evaluation by Asthma Controlled Test (ACT)
Time Frame
Patients will be followed for first moderate/severe asthma exacerbation rate or loss of asthma controlled (an estimated average duration of 24-48 weeks)
Title
Time to First moderate/severe asthma exacarbation rate
Description
Duration after randomisation until the patients will develop asthma exacerbation.
Time Frame
Patients will be followed for first moderate/severe asthma exacerbation rate (an estimated average duration of 24-48 weeks)
Title
Time to First loss of asthma controlled
Description
Duration after randomisation until the patients will have a loss of asthma control evaluating by Asthma Controlled Test (ACT)
Time Frame
Patients will be followed for loss of asthma controlled (an estimated average duration of 24-48 weeks)
Title
The ratio of asthma controlled to total number of participants
Description
The ratio of participants who will be classified for asthma controlled to total number of participants by ACT score
Time Frame
The ratio of asthma controlled to total number of participants at week 24th-48th.
Secondary Outcome Measure Information:
Title
Change in lung function: FEV1%predicted
Description
Change from baseline in FEV1%predicted
Time Frame
24-48 weeks.
Title
Change in blood eosinophil count
Description
The change of absoluted eosinophil count after step down medication
Time Frame
24-48 weeks.
Title
Change in FENO
Description
The change of FENO after step down medication
Time Frame
48 weeks.
Title
Mean dose of inhaled steroid
Description
The amount of inhaled steroid dose throughout the study
Time Frame
24-48 weeks.
Title
Change in lung function: Peak expiratory flow
Description
Change from baseline in Peak expiratory flow
Time Frame
24-48 weeks.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who have been diagnosed as asthma at least 6 months. Patients who have well controlled asthma by ACT > 23 and ACQ-7 < 0.75 at least 12 weeks with using budesonide/formoterol (160/4.5 μg/d) twice daily Patient who not be taking oral bronchodilator such as montelukast, theophylline, doxophylline but accept for taking anti histamine and intranasal steroid. Patients who able to do spirometry without contraindication. Exclusion Criteria: History of using systemic steroid previous 12 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. History smoking less than 10 pack-years or be smoking History of asthma exacabation previous 12 week
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Narongwit Nakwan, M.D.
Organizational Affiliation
Hatyai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hatyai Hospital
City
Hat Yai
State/Province
Songkhla
ZIP/Postal Code
90110
Country
Thailand

12. IPD Sharing Statement

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As-needed Budesonide/Formoterol Turbuhaler in Stepping Down Period

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