AsthmaPhase 4NCT03110874
Clinical Trial on Education Method of Fluterol® Inhalation Inhaler for Asthma Control
A Phase 4 study testing one-way education and two-way education in people with Asthma, run by Hanmi Pharmaceutical Company Limited.
Trial summary
A multi-center, randomized, open, non-inferiority, Phase 4 study Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- one-way education and two-way education
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2015to 10 May 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 15Show fewer
- 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.
About this study
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
A multi-center, randomized, open, non-inferiority, Phase 4 study
Read the 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
- Conditions
- Asthma
- Being tested
- one-way education, two-way education
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
one-way educationDrug
Also called video based education
'Fluterol Inhalation Capsule(fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) : one-way education'
two-way educationDrug
Also called direct education
'Fluterol Inhalation Capsule(fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) : two-way education'
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: two-way education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in Forced expiratory volume 1 sec (% prediction) at Week 12 from baseline in each group.
method of assessment:Forced expiratory volume
Measured: Week 12
Secondary outcomes (8)
percent change in Forced expiratory volume 1 sec (% prediction) at Week 4 from baseline in each group.
method of assessment:Forced expiratory volume
Measured: Week 4
Change in asthma control (ACT) at Weeks 4 and 12 from baseline in each group.
method of assessment: Check list
Measured: Weeks 4 and 12
Change in inhaler technique score at Weeks 4 and 12 from baseline in each group
method of assessment: Check list
Measured: Weeks 4 and 12
Number of critical errors at Weeks 4 and 12 in each group.
method of assessment: Check list
Measured: Weeks 4 and 12
Proportion of subjects with optimal inhaler technique at Weeks 4 and 12 in each group.
method of assessment: Check list
Measured: Weeks 4 and 12
Satisfaction for the inhalation drug at Weeks 4 and 12 in each group (FSI-10 score).
method of assessment: Check list
Measured: Weeks 4 and 12
Adherence rate (%) at Weeks 4 and 12 in each group.
method of assessment: drug administration calculation
Measured: Weeks 4 and 12
Safety endpoint:AEs(adverse events), vital signs, incidence rate of acute exacerbation.
occur frequency of adverse events and incidence rate of acute in each group, vital signs: blood pressure and pulse
Measured: baseline(day1),weeks 4 and weeks12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2017
- Study start8 Oct 2015
- Primary completion1 Sep 2016
- Study completion10 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Hanmi Pharmaceutical Company LimitedThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 184 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hanmi Pharmaceutical Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Byoung Whui Choi, Principal investigator, Chung-Ang University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03110874
- Sponsor's protocol ID
- HM-FLU-401
- Status last verified
- Feb 2018
- First submitted
- 31 Mar 2017
- Last updated
- 23 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03110874
- Acronym / sponsor ID
- HM-FLU-401
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 184 participants (actual)
- Lead sponsor
- Hanmi Pharmaceutical Company LimitedIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2015 (actual)
- Primary completion
- 1 Sep 2016 (actual)
- Study completion
- 10 May 2017 (actual)
- First posted
- 12 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group (one-way education) | Experimental | Drug: one-way educationExperimental group (one-way education) * Fluterol Inhalation Capsule (fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) * video based education |
| Control group(two-way education) | Active comparator | Drug: two-way educationControl group(two-way education) * Fluterol Inhalation Capsule (fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) * direct education |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| one-way educationAlso: video based education'Fluterol Inhalation Capsule(fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) : one-way education' | Drug | Experimental group (one-way education) |
| two-way educationAlso: direct education'Fluterol Inhalation Capsule(fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) : two-way education' | Drug | Control group(two-way education) |
Primary outcome
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
8 secondary outcomes
percent change in Forced expiratory volume 1 sec (% prediction) at Week 4 from baseline in each group.
Time frame: Week 4
Change in asthma control (ACT) at Weeks 4 and 12 from baseline in each group.
Time frame: Weeks 4 and 12
Change in inhaler technique score at Weeks 4 and 12 from baseline in each group
Time frame: Weeks 4 and 12
Number of critical errors at Weeks 4 and 12 in each group.
Time frame: Weeks 4 and 12
Proportion of subjects with optimal inhaler technique at Weeks 4 and 12 in each group.
Time frame: Weeks 4 and 12
Satisfaction for the inhalation drug at Weeks 4 and 12 in each group (FSI-10 score).
Time frame: Weeks 4 and 12
Adherence rate (%) at Weeks 4 and 12 in each group.
Time frame: Weeks 4 and 12
Safety endpoint:AEs(adverse events), vital signs, incidence rate of acute exacerbation.
Time frame: baseline(day1),weeks 4 and weeks12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Byoung Whui Choi principal investigator
Chung-Ang University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing one-way education and two-way education in people with Asthma, run by Hanmi Pharmaceutical Company Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in Forced expiratory volume 1 sec (% prediction) at Week 12 from baseline in each group. (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2018.