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

21. februar 2018 opdateret af: Hanmi Pharmaceutical Company Limited

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

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

184

Fase

  • Fase 4

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

19 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Experimental group (one-way education)

Experimental group (one-way education)

  • Fluterol Inhalation Capsule (fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg)
  • video based education
Medicin: one-way education
'Fluterol Inhalation Capsule(fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) : one-way education'
Andre navne:
  • videobaseret undervisning
Aktiv komparator: Control group(two-way education)

Control group(two-way education)

  • Fluterol Inhalation Capsule (fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg)
  • direct education
Medicin: two-way education
'Fluterol Inhalation Capsule(fluticasone propionate 250 μg, salmeterol xinafoate 72.5 μg) : two-way education'
Andre navne:
  • direct education

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percent change in Forced expiratory volume 1 sec (% prediction) at Week 12 from baseline in each group.
Tidsramme: Week 12
method of assessment:Forced expiratory volume
Week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
percent change in Forced expiratory volume 1 sec (% prediction) at Week 4 from baseline in each group.
Tidsramme: Week 4
method of assessment:Forced expiratory volume
Week 4
Change in asthma control (ACT) at Weeks 4 and 12 from baseline in each group.
Tidsramme: Weeks 4 and 12
method of assessment: Check list
Weeks 4 and 12
Change in inhaler technique score at Weeks 4 and 12 from baseline in each group
Tidsramme: Weeks 4 and 12
method of assessment: Check list
Weeks 4 and 12
Number of critical errors at Weeks 4 and 12 in each group.
Tidsramme: Weeks 4 and 12
method of assessment: Check list
Weeks 4 and 12
Proportion of subjects with optimal inhaler technique at Weeks 4 and 12 in each group.
Tidsramme: Weeks 4 and 12
method of assessment: Check list
Weeks 4 and 12
Satisfaction for the inhalation drug at Weeks 4 and 12 in each group (FSI-10 score).
Tidsramme: Weeks 4 and 12
method of assessment: Check list
Weeks 4 and 12
Adherence rate (%) at Weeks 4 and 12 in each group.
Tidsramme: Weeks 4 and 12
method of assessment: drug administration calculation
Weeks 4 and 12
Safety endpoint:AEs(adverse events), vital signs, incidence rate of acute exacerbation.
Tidsramme: 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
baseline(day1),weeks 4 and weeks12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hanmi Pharmaceutical Company Limited

Efterforskere

  • Ledende efterforsker: Byoung Whui Choi, Chung-Ang University Hosptial, Chung-Ang University College of Medicine

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. oktober 2015

Primær færdiggørelse (Faktiske)

1. september 2016

Studieafslutning (Faktiske)

10. maj 2017

Datoer for studieregistrering

Først indsendt

31. marts 2017

Først indsendt, der opfyldte QC-kriterier

6. april 2017

Først opslået (Faktiske)

12. april 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

23. februar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. februar 2018

Sidst verificeret

1. februar 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HM-FLU-401

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Betingelser

Sjældne sygdomme

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Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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