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

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02725242
• Other study ID #: 064/2014
• Status: Completed
• Phase: Phase 3
• First received: January 20, 2016
• Last updated: April 14, 2017
• Start date: March 2016
• Est. completion date: December 2016

Study information

• Verified date: April 2017
• Source: Hat Yai Medical Education Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

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)
• Budesonide (400µg/d)
After the patients who have all criteria, they will be randomization to take Budesonide (200 ug) twice daily

Locations

Country	Name	City	State
Thailand	Narongwit Nakwan	Hatyai	Songkhla

Sponsors (1)

Lead Sponsor	Collaborator
Hat Yai Medical Education Center

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in Asthma Control Questionnaire (ACQ) score	Asthma Control Questionnaire (ACQ) that is 6 items of self-administered and 1 item of FEV1%. It has 7-point scale (=no impairment, 6= maximum impairment for symptoms and rescue use; and 7 categories for FEV1%). Scores range between 0 (totally controlled) and 6 (severely uncontrolled).	Baseline and week 12
Primary	Change from baseline in Asthma Controlled Test (ACT) score	1. Asthma Controlled Test (ACT); grouped in five domains; frequency of shortness of breath, general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled). The scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma	Baseline, week 4, week 8 and week 12
Secondary	Change from baseline in Peak expiratory flow (PEF)	The mean value of PEF (Litre per minute) for baseline, week 4, 8 and 12 was analysed.	Baseline, week 4, week 8 and week 12
Secondary	Change from baseline in Forced Expiratory Volume in One Second (FEV1)	The mean value for baseline and week 12 was analysed.	Baseline and week 12
Secondary	Percentage of participants who were categorized from asthma controlled assessment following GINA guideline		Baseline, week 4, week 8 and week 12