NCT04215848

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Hat Yai Medical Education Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Asthma

Interventions

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

Timeline

• Start date: 2020-04-01
• Primary completion: 2021-10-10
• Completion: 2022-05-30
• First posted: 2020-01-02
• Last updated: 2022-08-03

Locations

1 site across 1 country: Thailand