Clinical Trial on Education Method of Fluterol® Inhalation Inhaler for Asthma Control
NCT ID: NCT03110874
Last Updated: 2018-02-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
184 participants
INTERVENTIONAL
2015-10-08
2017-05-10
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Experimental group (one-way education)
Experimental group (one-way education)
* Fluterol Inhalation Capsule (fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg)
* video based education
one-way education
'Fluterol Inhalation Capsule(fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) : one-way education'
Control group(two-way education)
Control group(two-way education)
* Fluterol Inhalation Capsule (fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg)
* direct education
two-way education
'Fluterol Inhalation Capsule(fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) : two-way education'
Interventions
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one-way education
'Fluterol Inhalation Capsule(fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) : one-way education'
two-way education
'Fluterol Inhalation Capsule(fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) : two-way education'
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient with partially controlled asthma (Asthma Control Test score 16\~24)
3. Written informed consent to study participation.
Exclusion Criteria
2. Cardiac tachyarrhythmia.
3. contreated respiratory fungal, bacterial, or tuberculous infection.
4. Moderate to severe bronchiectasis
5. Planned use of the investigational product (Fluterol®) as primary treatment for patients with status asthmaticus, patients with an asthmatic crisis\*, or patients with chronic obstructive pulmonary disease requiring intensive treatment.
* Asthmatic crisis: acute exacerbation of asthma meeting at least one of the followings.
* Asthma related emergency room visit or hospitalization within 2 weeks prior to screening.
* Administration of systemic steroids within 2 weeks prior to screening.
* Inhalation of rescue medication at least 10 times/day for the treatment of acute exacerbation of asthmatic symptoms within 2 weeks prior to screening.
6. Administration of systemic steroids within 2 weeks prior to screening.
7. Hypersensitivity reactions to lactose and milk.
8. Pregnant and lactating women or women who are planning to be pregnant or who are unwilling to use appropriate methods of contraception during the study.
9. Previous use of the investigational product (Fluterol®) or a similar inhaler (Onbrez, Spiriva) at least once.
10. Participation in another clinical study for drugs or medical devices to receive the investigational product or undergo a procedure using the investigational device within 4 weeks prior to participation in this study.
11. Individual considered by the he investigator to be inappropriate for study participation due to other reasons.
19 Years
ALL
No
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Byoung Whui Choi
Role: PRINCIPAL_INVESTIGATOR
Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Other Identifiers
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HM-FLU-401
Identifier Type: -
Identifier Source: org_study_id
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