As-needed Budesonide/Formoterol Turbuhaler in Stepping Down Period

NCT04215848 | Completed Phase 3 DMC

• 1 other identifier: 023/2562
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Asthma

Keywords

asthma; allergy

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Change in lung function: FEV1%predicted

  24-48 weeks.

• Change in blood eosinophil count

  24-48 weeks.

• Change in FENO

  48 weeks.

• Mean dose of inhaled steroid

  24-48 weeks.

• Change in lung function: Peak expiratory flow

  24-48 weeks.

Study Arms (2)

As-needed Budesonide/Formoterol

EXPERIMENTAL

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

Drug: Budesonide/Formoterol Fumarate 160 MCG-4.5 MCG Inhalation Powder

Budesonide

ACTIVE COMPARATOR

Budesonide (200 ug) twice daily

Drug: Budesonide 200Mcg Inhalation Powder

Interventions

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.

Also known as: Symbicort Turbuhaler (160/4.5 ug)

As-needed Budesonide/Formoterol

Budesonide 200Mcg Inhalation Powder DRUG

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

Also known as: Pulmicort Turbuhaler (200 ug)

Budesonide

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hat Yai Medical Education Center: lead

Study Sites (1)

Hatyai Hospital

Hat Yai, Changwat Songkhla, 90110, Thailand

Location

MeSH Terms

Conditions

Asthma; Hypersensitivity

Interventions

Budesonide; Formoterol Fumarate; Budesonide, Formoterol Fumarate Drug Combination

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Drug Combinations; Pharmaceutical Preparations

Study Officials

• Narongwit Nakwan, M.D.

  HatYai Hospital

  PRINCIPAL INVESTIGATOR

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: December 20, 2019
• First Posted: January 2, 2020
• Study Start: April 1, 2020
• Primary Completion: October 10, 2021
• Study Completion: May 30, 2022
• Last Updated: August 3, 2022

Record last verified: 2022-08

Locations

TH (1)