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Corticosteroid

As-needed Budesonide/Formoterol for Asthma

Phase 3
Waitlist Available
Led By Narongwit Nakwan, M.D.
Research Sponsored by Hat Yai Medical Education Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-48 weeks.
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group
Pivotal 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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-48 weeks.
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-48 weeks. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
The ratio of asthma controlled to total number of participants
Time to First loss of asthma controlled
Time to First moderate/severe asthma exacarbation rate
+1 more
Secondary study objectives
Change in FENO
Change in blood eosinophil count
Change in lung function: FEV1%predicted
+2 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: As-needed Budesonide/FormoterolExperimental Treatment1 Intervention
As-needed Budesonide/Formoterol (160/4.5 ug)
Group II: BudesonideActive Control1 Intervention
Budesonide (200 ug) twice daily
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Formoterol
FDA approved

Find a Location

Who is running the clinical trial?

Hat Yai Medical Education CenterLead Sponsor
7 Previous Clinical Trials
2,042 Total Patients Enrolled
4 Trials studying Asthma
730 Patients Enrolled for Asthma
Narongwit Nakwan, M.D.Principal InvestigatorHatYai Hospital
3 Previous Clinical Trials
646 Total Patients Enrolled
3 Trials studying Asthma
646 Patients Enrolled for Asthma
~6 spots leftby Oct 2025
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