As-needed Budesonide/Formoterol Turbuhaler in Stepping Down Period

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Budesonide/Formoterol Fumarate 160 MCG-4.5 MCG Inhalation Powder; Drug: Budesonide 200Mcg Inhalation Powder

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.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 3

Contacts and Locations

Study Locations

• Thailand
  • Songkhla
    • Hat Yai, Songkhla, Thailand, 90110
      • Hatyai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: As-needed Budesonide/Formoterol; As-needed Budesonide/Formoterol (160/4.5 ug)	Drug: 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.; Other Names: Symbicort Turbuhaler (160/4.5 ug)
Active Comparator: Budesonide; Budesonide (200 ug) twice daily	Drug: Budesonide 200Mcg Inhalation Powder; After the patients who have all criteria, they will be randomized to take Budesonide (200 μg) twice daily; Other Names: Pulmicort Turbuhaler (200 ug)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Patients will be followed for first moderate/severe asthma exacerbation rate or loss of asthma controlled (an estimated average duration of 24-48 weeks)
Time to First moderate/severe asthma exacarbation rate	Duration after randomisation until the patients will develop asthma exacerbation.	Patients will be followed for first moderate/severe asthma exacerbation rate (an estimated average duration of 24-48 weeks)
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)	Patients will be followed for loss of asthma controlled (an estimated average duration of 24-48 weeks)
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	The ratio of asthma controlled to total number of participants at week 24th-48th.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in lung function: FEV1%predicted	Change from baseline in FEV1%predicted	24-48 weeks.
Change in blood eosinophil count	The change of absoluted eosinophil count after step down medication	24-48 weeks.
Change in FENO	The change of FENO after step down medication	48 weeks.
Mean dose of inhaled steroid	The amount of inhaled steroid dose throughout the study	24-48 weeks.
Change in lung function: Peak expiratory flow	Change from baseline in Peak expiratory flow	24-48 weeks.

Collaborators and Investigators

• Sponsor: Hat Yai Medical Education Center
• Investigators: Principal Investigator: Narongwit Nakwan, M.D., Hatyai Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2020
• Primary Completion (Actual): October 10, 2021
• Study Completion (Actual): May 30, 2022

Study Registration Dates

• First Submitted: December 20, 2019
• First Submitted That Met QC Criteria: December 31, 2019
• First Posted (Actual): January 2, 2020

Study Record Updates

• Last Update Posted (Actual): August 3, 2022
• Last Update Submitted That Met QC Criteria: August 2, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: asthma; allergy
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenergic Agonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Adrenergic beta-2 Receptor Agonists; Adrenergic beta-Agonists; Budesonide; Formoterol Fumarate
• Other Study ID Numbers: 023/2562

Drug and device information, study documents

• 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