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Completed

NCT Number: NCT04215848

As-needed Budesonide/Formoterol Turbuhaler in Stepping Down Period

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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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hatyai Hospital

Hat Yai, Changwat Songkhla, 90110, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Budesonide/Formoterol Fumarate 160 MCG-4.5 MCG Inhalation Powder

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.

Other names: Symbicort Turbuhaler (160/4.5 ug)

Budesonide 200Mcg Inhalation Powder

Drug

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

Other names: Pulmicort Turbuhaler (200 ug)

Primary outcomes

  1. Time to First moderate/severe asthma exacerbation rate or loss of asthma controlled

    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)

    Duration after the patients who has been randomised to developed asthma exacerbation or loss of asthma control that evaluation by Asthma Controlled Test (ACT)

  2. Time to First moderate/severe asthma exacarbation rate

    Time frame: Patients will be followed for first moderate/severe asthma exacerbation rate (an estimated average duration of 24-48 weeks)

    Duration after randomisation until the patients will develop asthma exacerbation.

  3. Time to First loss of asthma controlled

    Time frame: Patients will be followed for loss of asthma controlled (an estimated average duration of 24-48 weeks)

    Duration after randomisation until the patients will have a loss of asthma control evaluating by Asthma Controlled Test (ACT)

  4. The ratio of asthma controlled to total number of participants

    Time frame: The ratio of asthma controlled to total number of participants at week 24th-48th.

    The ratio of participants who will be classified for asthma controlled to total number of participants by ACT score

Secondary outcomes

  1. Change in lung function: FEV1%predicted

    Time frame: 24-48 weeks.

    Change from baseline in FEV1%predicted

  2. Change in blood eosinophil count

    Time frame: 24-48 weeks.

    The change of absoluted eosinophil count after step down medication

  3. Change in FENO

    Time frame: 48 weeks.

    The change of FENO after step down medication

  4. Mean dose of inhaled steroid

    Time frame: 24-48 weeks.

    The amount of inhaled steroid dose throughout the study

  5. Change in lung function: Peak expiratory flow

    Time frame: 24-48 weeks.

    Change from baseline in Peak expiratory flow

Sponsors and collaborators

Lead sponsor

Hat Yai Medical Education Center

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Jan 2, 2020
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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