As-needed Budesonide/Formoterol Turbuhaler in Stepping Down Period

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-01

Study Completion Date

2022-05-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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As-needed Budesonide/Formoterol

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

Group Type EXPERIMENTAL

Budesonide/Formoterol Fumarate 160 MCG-4.5 MCG Inhalation Powder

Intervention Type DRUG

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.

Budesonide

Budesonide (200 ug) twice daily

Group Type ACTIVE_COMPARATOR

Budesonide 200Mcg Inhalation Powder

Intervention Type DRUG

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

Interventions

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Budesonide/Formoterol Fumarate 160 MCG-4.5 MCG Inhalation Powder

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

Budesonide 200Mcg Inhalation Powder

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

Intervention Type DRUG

Other Intervention Names

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Symbicort Turbuhaler (160/4.5 ug) Pulmicort Turbuhaler (200 ug)

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No