Clinical trial NCT03110874: Clinical Trial on Education Method of Fluterol® Inhalation Inhaler for Asthma Control
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2017-04-12
Enrollment: 184
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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

Eligibility criteria: 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.

Primary outcomes:
measure: Percent change in Forced expiratory volume 1 sec (% prediction) at Week 12 from baseline in each group.
timeFrame: Week 12
Secondary outcomes:
measure: percent change in Forced expiratory volume 1 sec (% prediction) at Week 4 from baseline in each group.
timeFrame: Week 4
measure: Change in asthma control (ACT) at Weeks 4 and 12 from baseline in each group.
timeFrame: Weeks 4 and 12
measure: Change in inhaler technique score at Weeks 4 and 12 from baseline in each group
timeFrame: Weeks 4 and 12
measure: Number of critical errors at Weeks 4 and 12 in each group.
timeFrame: Weeks 4 and 12
measure: Proportion of subjects with optimal inhaler technique at Weeks 4 and 12 in each group.
timeFrame: Weeks 4 and 12
measure: Satisfaction for the inhalation drug at Weeks 4 and 12 in each group (FSI-10 score).
timeFrame: Weeks 4 and 12
measure: Adherence rate (%) at Weeks 4 and 12 in each group.
timeFrame: Weeks 4 and 12
measure: Safety endpoint:AEs(adverse events), vital signs, incidence rate of acute exacerbation.
timeFrame: baseline(day1),weeks 4 and weeks12
Other outcomes:
Locations:
Study officials:
affiliation: Chung-Ang University Hosptial, Chung-Ang University College of Medicine
name: Byoung Whui Choi
role: PRINCIPAL_INVESTIGATOR
References: