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

NCT ID: NCT02725242

Last Updated: 2017-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

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

Group Type EXPERIMENTAL

Budesonide/formoterol (160/4.5 μg/d)

Intervention Type DRUG

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

Twice-daily Budesonide (200μg)

twice-daily Budesonide (400μg/d)

Group Type ACTIVE_COMPARATOR

Budesonide (400μg/d)

Intervention Type DRUG

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type DRUG

Budesonide (400μg/d)

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Symbicort Turbuhaler (160/4.5 μg/d) Giona Easyhaler

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hat Yai Medical Education Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Narongwit Nakwan

Head of Pulmonology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Narongwit Nakwan, M.D.

Role: STUDY_CHAIR

HatYai Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Narongwit Nakwan

Hat Yai, Changwat Songkhla, Thailand

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Thailand

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

064/2014

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Triple in Asthma Dose Finding
NCT02127866 COMPLETED PHASE2