As-needed Budesonide/Formoterol Turbuhaler in Stepping Down Period

Asthma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04215848
• Other study ID #: 023/2562
• Status: Completed
• Phase: Phase 3
• Start date: April 1, 2020
• Est. completion date: May 30, 2022

Study information

• Verified date: August 2022
• Source: Hat Yai Medical Education Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: May 30, 2022
• Est. primary completion date: October 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma

Intervention

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

Locations

Country	Name	City	State
Thailand	Hatyai Hospital	Hat Yai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Hat Yai Medical Education Center

Country where clinical trial is conducted

Thailand, 

Outcome

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