NCT03110874

Brief Summary

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
184

participants targeted

Target at P50-P75 for phase_4 asthma

Timeline
Completed

Started Oct 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 8, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 31, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 12, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 10, 2017

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

11 months

First QC Date

March 31, 2017

Last Update Submit

February 21, 2018

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Percent change in Forced expiratory volume 1 sec (% prediction) at Week 12 from baseline in each group.

    method of assessment:Forced expiratory volume

    Week 12

Secondary Outcomes (8)

  • percent change in Forced expiratory volume 1 sec (% prediction) at Week 4 from baseline in each group.

    Week 4

  • Change in asthma control (ACT) at Weeks 4 and 12 from baseline in each group.

    Weeks 4 and 12

  • Change in inhaler technique score at Weeks 4 and 12 from baseline in each group

    Weeks 4 and 12

  • Number of critical errors at Weeks 4 and 12 in each group.

    Weeks 4 and 12

  • Proportion of subjects with optimal inhaler technique at Weeks 4 and 12 in each group.

    Weeks 4 and 12

  • +3 more secondary outcomes

Study Arms (2)

Experimental group (one-way education)

EXPERIMENTAL

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

Drug: one-way education

Control group(two-way education)

ACTIVE COMPARATOR

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

Drug: two-way education

Interventions

one-way educationDRUG

'Fluterol Inhalation Capsule(fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) : one-way education'

Also known as: video based education
Experimental group (one-way education)
two-way educationDRUG

'Fluterol Inhalation Capsule(fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) : two-way education'

Also known as: direct education
Control group(two-way education)

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • History of hypersensitivity reactions to the investigational product (Fluterol®) or any of its component.
  • Cardiac tachyarrhythmia.
  • contreated respiratory fungal, bacterial, or tuberculous infection.
  • Moderate to severe bronchiectasis
  • 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.
  • Administration of systemic steroids within 2 weeks prior to screening.
  • Hypersensitivity reactions to lactose and milk.
  • 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.
  • Previous use of the investigational product (Fluterol®) or a similar inhaler (Onbrez, Spiriva) at least once.
  • 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.
  • Individual considered by the he investigator to be inappropriate for study participation due to other reasons.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Byoung Whui Choi

    Chung-Ang University Hosptial, Chung-Ang University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2017

First Posted

April 12, 2017

Study Start

October 8, 2015

Primary Completion

September 1, 2016

Study Completion

May 10, 2017

Last Updated

February 23, 2018

Record last verified: 2018-02