Clinical Trial on Education Method of Fluterol® Inhalation Inhaler for Asthma Control

Hanmi Pharmaceutical

Status and phase: Completed; Phase 4

Conditions: Asthma

Treatments: Drug: two-way education; Drug: one-way education

Study type: Interventional

Funder types: Industry

Identifiers

NCT03110874

HM-FLU-401

Details and patient eligibility

About

A multi-center, randomized, open, non-inferiority, Phase 4 study

Full description

A Multi-center, Randomized, Interventional, Open, Phase Ⅳ Clinical Trial on Education Method of Fluterol® Inhalation Capsule 250/50 μg Inhaler for Asthma Control in Patients with Partly Controlled Asthma

Enrollment: 184 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Adult at the age of 19 or older.
2. Patient with partially controlled asthma (Asthma Control Test score 16~24)
3. Written informed consent to study participation.

Exclusion criteria

1. History of hypersensitivity reactions to the investigational product (Fluterol®) or any of its component.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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184 participants in 2 patient groups

Experimental group (one-way education)

Experimental group

Description:

Experimental group (one-way education) * Fluterol Inhalation Capsule (fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) * video based education

Treatment:

Drug: one-way education

Control group(two-way education)

Active Comparator group

Description:

Control group(two-way education) * Fluterol Inhalation Capsule (fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) * direct education

Treatment:

Drug: two-way education