Trial | NCT02725242  Report issue

Title

Efficacy of Once-daily Budesonide/Formoterol Turbuhaler 4.5/160 µg in Step Down Asthma
A 12-week, Randomized, Parallel-group, Phase III Study Comparing the Efficacy of Once-daily Budesonide/Formoterol Turbuhaler (160/4.5 μg/d) and Twice-daily Budesonide Giona Easyhaler (400 μg/d) During Step-down Period in Well Controlled Asthma

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    formoterol budesonide ...

  • Study Participants

    77
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.
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.
Study Started
Mar 31
2016
Primary Completion
Dec 31
2016
Study Completion
Dec 31
2016
Last Update
Apr 18
2017

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

After the patients who have all criteria, they will be randomization to take Budesonide/formoterol (160/4.5 μg/d)

  • Other names: Symbicort Turbuhaler (160/4.5 μg/d)

Drug Budesonide (400μg/d)

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

  • Other names: Giona Easyhaler

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

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

Twice-daily Budesonide (200μg) Active Comparator

twice-daily Budesonide (400μg/d)

Criteria 

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.
No Results Posted