Efficacy of Once-daily Budesonide/Formoterol Turbuhaler 4.5/160 µg in Step Down Asthma

Hat Yai Medical Education Center

Status and phase: Completed; Phase 3

Conditions: Asthma

Treatments: Drug: Budesonide (400μg/d); Drug: Budesonide/formoterol (160/4.5 μg/d)

Study type: Interventional

Funder types: Other

Identifiers

NCT02725242

064/2014

Details and patient eligibility

About

This study will evaluate the efficacy of Once-daily Budesonide/formoterol Turbuhaler 160/4.5 µg/d in the period of step down in well controlled asthmatic patient.

Full description

The study will measure the efficacy of once daily low dose ICS/ LABA in well controlled asthmatic patient comparing with low dose ICS in step down circumstance.

Enrollment: 77 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Asthmatic patients who have well controlled asthma at least 12 weeks with using budesonide/formoterol (160/4.5 μg/d) twice daily
• Age more than 18 year-old
• Patients who able to do spirometry without contraindication
• History smoking less than 10 pack-years

Exclusion criteria

• History of using systemic steroid previous 4 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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77 participants in 2 patient groups

Once-daily budesonide/formoterol (160/4.5 μg/d)

Experimental group

Description:

once-daily budesonide/formoterol (160/4.5 μg/d)

Treatment:

Drug: Budesonide/formoterol (160/4.5 μg/d)

Twice-daily Budesonide (200μg)

Active Comparator group

Description:

twice-daily Budesonide (400μg/d)

Treatment:

Drug: Budesonide (400μg/d)