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Completed

NCT Number: NCT03110874

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

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

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

one-way education

Drug

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

Other names: video based education

two-way education

Drug

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

Other names: direct education

Primary outcomes

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

    Time frame: Week 12

    method of assessment:Forced expiratory volume

Secondary outcomes

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

    Time frame: Week 4

    method of assessment:Forced expiratory volume

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

    Time frame: Weeks 4 and 12

    method of assessment: Check list

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

    Time frame: Weeks 4 and 12

    method of assessment: Check list

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

    Time frame: Weeks 4 and 12

    method of assessment: Check list

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

    Time frame: Weeks 4 and 12

    method of assessment: Check list

  6. Satisfaction for the inhalation drug at Weeks 4 and 12 in each group (FSI-10 score).

    Time frame: Weeks 4 and 12

    method of assessment: Check list

  7. Adherence rate (%) at Weeks 4 and 12 in each group.

    Time frame: Weeks 4 and 12

    method of assessment: drug administration calculation

  8. Safety endpoint:AEs(adverse events), vital signs, incidence rate of acute exacerbation.

    Time frame: baseline(day1),weeks 4 and weeks12

    occur frequency of adverse events and incidence rate of acute in each group, vital signs: blood pressure and pulse

Sponsors and collaborators

Lead sponsor

Hanmi Pharmaceutical Company Limited

Industry

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Apr 12, 2017
Registry last updated
Feb 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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