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

April 14, 2017 updated by: Narongwit Nakwan, Hat Yai Medical Education Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

77

Phase

  • Phase 3

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

  • Thailand
    • Songkhla
      • Hatyai, Songkhla, Thailand, 90110
        • Narongwit Nakwan

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Once-daily budesonide/formoterol (160/4.5 μg/d)
once-daily budesonide/formoterol (160/4.5 μg/d)
Drug: Budesonide/formoterol (160/4.5 μg/d)
After the patients who have all criteria, they will be randomization to take Budesonide/formoterol (160/4.5 μg/d)
Other Names:
  • Symbicort Turbuhaler (160/4.5 μg/d)
ACTIVE_COMPARATOR: Twice-daily Budesonide (200μg)
twice-daily Budesonide (400μg/d)
Drug: Budesonide (400μg/d)
After the patients who have all criteria, they will be randomization to take Budesonide (200 ug) twice daily
Other Names:
  • Giona Easyhaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Asthma Control Questionnaire (ACQ) score
Time Frame: Baseline and week 12
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).
Baseline and week 12
Change from baseline in Asthma Controlled Test (ACT) score
Time Frame: Baseline, week 4, week 8 and week 12
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
Baseline, week 4, week 8 and week 12

Secondary Outcome Measures

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

Collaborators and Investigators

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

Sponsor

Hat Yai Medical Education Center

Investigators

  • Study Chair: Narongwit Nakwan, M.D., Hatyai Hospital

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

March 1, 2016

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

December 1, 2016

Study Registration Dates

First Submitted

January 20, 2016

First Submitted That Met QC Criteria

March 30, 2016

First Posted (ESTIMATE)

March 31, 2016

Study Record Updates

Last Update Posted (ACTUAL)

April 18, 2017

Last Update Submitted That Met QC Criteria

April 14, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 064/2014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Asthma

Clinical Trials on Budesonide/formoterol (160/4.5 μg/d)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Gambia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe