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Completed

NCT Number: NCT02725242

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

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.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Narongwit Nakwan

Hat Yai, Changwat Songkhla, 90110, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Budesonide/formoterol (160/4.5 μg/d)

Drug

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)

Budesonide (400μg/d)

Drug

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

Other names: Giona Easyhaler

Primary outcomes

  1. Change from baseline in Asthma Control Questionnaire (ACQ) score

    Time frame: Baseline and week 12

    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).

  2. Change from baseline in Asthma Controlled Test (ACT) score

    Time frame: Baseline, week 4, week 8 and week 12

    • 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

Secondary outcomes

  1. Change from baseline in Peak expiratory flow (PEF)

    Time frame: Baseline, week 4, week 8 and week 12

    The mean value of PEF (Litre per minute) for baseline, week 4, 8 and 12 was analysed.

  2. Change from baseline in Forced Expiratory Volume in One Second (FEV1)

    Time frame: Baseline and week 12

    The mean value for baseline and week 12 was analysed.

  3. Percentage of participants who were categorized from asthma controlled assessment following GINA guideline

    Time frame: Baseline, week 4, week 8 and week 12

Sponsors and collaborators

Lead sponsor

Hat Yai Medical Education Center

Other

Registry information

Official study 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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 31, 2016
Registry last updated
Apr 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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