NCT02725242

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at below P25 for phase_3 asthma

Timeline
Completed

Started Mar 2016

Shorter than P25 for phase_3 asthma

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 20, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 31, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

April 18, 2017

Status Verified

April 1, 2017

Enrollment Period

9 months

First QC Date

January 20, 2016

Last Update Submit

April 14, 2017

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

  • 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).

    Baseline and week 12

  • 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

    Baseline, week 4, week 8 and week 12

Secondary Outcomes (3)

  • Change from baseline in Peak expiratory flow (PEF)

    Baseline, week 4, week 8 and week 12

  • Change from baseline in Forced Expiratory Volume in One Second (FEV1)

    Baseline and week 12

  • Percentage of participants who were categorized from asthma controlled assessment following GINA guideline

    Baseline, week 4, week 8 and week 12

Study Arms (2)

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

EXPERIMENTAL

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

Drug: Budesonide/formoterol (160/4.5 μg/d)

Twice-daily Budesonide (200μg)

ACTIVE COMPARATOR

twice-daily Budesonide (400μg/d)

Drug: Budesonide (400μg/d)

Interventions

Budesonide/formoterol (160/4.5 μg/d)DRUG

After the patients who have all criteria, they will be randomization to take Budesonide/formoterol (160/4.5 μg/d)

Also known as: Symbicort Turbuhaler (160/4.5 μg/d)
Once-daily budesonide/formoterol (160/4.5 μg/d)
Budesonide (400μg/d)DRUG

After the patients who have all criteria, they will be randomization to take Budesonide (200 ug) twice daily

Also known as: Giona Easyhaler
Twice-daily Budesonide (200μg)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Narongwit Nakwan

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Asthma

Interventions

BudesonideFormoterol FumarateBudesonide, Formoterol Fumarate Drug Combination

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesDrug CombinationsPharmaceutical Preparations

Study Officials

  • Narongwit Nakwan, M.D.

    HatYai Hospital

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Pulmonology

Study Record Dates

First Submitted

January 20, 2016

First Posted

March 31, 2016

Study Start

March 1, 2016

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

April 18, 2017

Record last verified: 2017-04

Locations

TH(1)