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NCT04215848 | Completed | Asthma

As-needed Budesonide/Formoterol Turbuhaler in Stepping Down Period
Sponsor:

Hat Yai Medical Education Center

Information provided by (Responsible Party):

Narongwit Nakwan

Brief 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.

Condition or disease

Asthma

Intervention/treatment

Budesonide/Formoterol Fumarate 160 MCG-4.5 MCG Inhalation Powder

Budesonide 200Mcg Inhalation Powder

Phase

Phase 3

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.}}

Study Type : Interventional
Estimated Enrollment : 31 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : 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
Actual Study Start Date : April 1, 2020
Estimated Primary Completion Date : October 10, 2021
Estimated Study Completion Date : May 30, 2022
Arm Intervention/treatment

Experimental: As-needed Budesonide/Formoterol

As-needed Budesonide/Formoterol (160/4.5 ug)

Drug: Budesonide/Formoterol Fumarate 160 MCG-4.5 MCG Inhalation Powder

Active Comparator: Budesonide

Budesonide (200 ug) twice daily

Drug: Budesonide 200Mcg Inhalation Powder
Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Patients who have been diagnosed as asthma at least 6 months.
  • Patients who have well controlled asthma by ACT > 23 and ACQ-7 < 0.75 at least 12 weeks with using budesonide/formoterol (160/4.5 μg/d) twice daily
  • Patient who not be taking oral bronchodilator such as montelukast, theophylline, doxophylline but accept for taking anti histamine and intranasal steroid.
  • Patients who able to do spirometry without contraindication.
Exclusion Criteria
  • History of using systemic steroid previous 12 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.
  • History smoking less than 10 pack-years or be smoking
  • History of asthma exacabation previous 12 week
As-needed Budesonide/Formoterol Turbuhaler in Stepping Down Period

Location Details

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As-needed Budesonide/Formoterol Turbuhaler in Stepping Down Period

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Thailand, Songkhla

Hatyai Hospital

Hat Yai, Songkhla, Thailand, 90110