A Comparative Study on the Efficacy of Different Stepping-down Therapy for Childhood Asthma
29. juni 2021 oppdatert av: Xijing Hospital
This study is a 24-week, randomized, parallel group comparative effectiveness study to evaluate the risk of stepping down therapy for patients with well-controlled asthma treated with combination Inhaled corticosteroids (ICS) and Leukotriene receptor antagonist（LTRA).
Studieoversikt
Status
Ukjent
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Asthma guidelines recommend stepping down therapy once asthma is controlled for at least 3 months.
Leukotriene receptor antagonist（LTRA).
For children with mild persistent asthma, ICS twice a day combined with LTRA can be used for treatment, but there is no consensus on how to reduce drugs in patients with asthma that is well controlled (reducing the dose of ICS or stopping montelukast).
We propose a 24-week, randomized, parallel group comparative effectiveness study comparing three approaches in patients with asthma well-controlled for at least three months on combination ICS and LTRA: Halve the dose of ICS firstly and then stop ICS with montelukast only, stop montelukast firstly and then halve the dose of ICS, and halve the dose of ICS firstly and then stop montelukast.
Our goal is to compare the rate of treatment failure and determine the optimal treatment strategy.
Additional goals include assessing risk factors for step-down failure.
Studietype
Intervensjonell
Registrering (Forventet)
90
Fase
- Fase 4
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Shanxi
-
Xi'an, Shanxi, Kina, 710032
- Department of Pediatrics, Xijing Hospital
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
4 år til 14 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- age 4-14 years
- patients had mild to moderate persistent asthma. Patients have treated with low-dose inhaled corticosteroids (equivalent to Fluticasone propionate inhaled aerosol 250 ug/ day) combined with Leukotriene receptor antagonist (Montelulast) at least 6 months of and had no symptoms of asthma for nearly 3 months under well asthma control(Asthma Control Test (ACT) score more than or equal to 20).
- patients did not suffer from other acute or chronic diseases that may affect their growth and development
Exclusion Criteria:
- patients with severe persistent asthma or mild persistent asthma failed to be well controlled by low-dose ICS after starting treatment
- suffer from other diseases: Congenital heart disease, chronic infectious disease, protracted diarrhea, congenital airway disease, congenital vascular ring malformation, congenital immune deficiency, tracheal foreign body, bronchial lymph node tuberculosis and gastroesophageal reflux etc.
- patients with poor compliance stop medication or fail to take medication on time.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Aktiv komparator: Stop Fluticasone propionate Inhaled Aerosol Firstly
Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped Fluticasone propionate Inhaled Aerosol and continuation of montelukast once a day
|
The study consists of two stages and include three groups.
Three groups include: Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped Fluticasone propionate Inhaled Aerosol and continuation of montelukast once a day; Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug once a day; Stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug twice daily, and then Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day.
The scheme of every group is divided into two stages.
Only those whose asthma are well controlled at the end of the first phase will be allowed to proceed to the next phase.
|
|
Aktiv komparator: Stop Montelukast Secondly
Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug once a day
|
The study consists of two stages and include three groups.
Three groups include: Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped Fluticasone propionate Inhaled Aerosol and continuation of montelukast once a day; Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug once a day; Stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug twice daily, and then Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day.
The scheme of every group is divided into two stages.
Only those whose asthma are well controlled at the end of the first phase will be allowed to proceed to the next phase.
|
|
Aktiv komparator: Stop Montelukast Firstly
stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug twice daily, and then Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day
|
The study consists of two stages and include three groups.
Three groups include: Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped Fluticasone propionate Inhaled Aerosol and continuation of montelukast once a day; Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day and continuation of montelukast once a day，and then stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug once a day; Stopped montelukast and continuation of Fluticasone propionate Inhaled Aerosol 125 ug twice daily, and then Reduced dose Fluticasone propionate Inhaled Aerosol 125 ug once a day.
The scheme of every group is divided into two stages.
Only those whose asthma are well controlled at the end of the first phase will be allowed to proceed to the next phase.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Asthma Control Test (ACT) score
Tidsramme: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
|
Change in participant's Asthma Control Test (ACT) score
|
Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
|
|
Number of Participants Who Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
Tidsramme: Baseline (Week 0) to Week 12
|
Participants Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
|
Baseline (Week 0) to Week 12
|
|
Number of Participants Who Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
Tidsramme: Baseline (Week 0) to Week 24
|
Participants Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
|
Baseline (Week 0) to Week 24
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Fractional exhaled Nitric Oxide, FeNO
Tidsramme: Baseline, 12 weeks and 24 weeks
|
Change in participant's Fractional exhaled Nitric Oxide
|
Baseline, 12 weeks and 24 weeks
|
|
Forced expiratory volume in one second in predicted（FEV1%pred）
Tidsramme: Baseline, 12 weeks and 24 weeks
|
Change in participant's Forced expiratory volume in one second in predicted
|
Baseline, 12 weeks and 24 weeks
|
|
Forced vital capacity in predicted(FVC%pred)
Tidsramme: Baseline, 12 weeks and 24 weeks
|
Change in participant's Forced vital capacity in predicted
|
Baseline, 12 weeks and 24 weeks
|
|
Maximal mid expiratory flow in predicted(MMEF%pred)
Tidsramme: Baseline, 12 weeks and 24 weeks
|
Change in participant's Maximal mid expiratory flow in predicted
|
Baseline, 12 weeks and 24 weeks
|
|
Peak expiratory flow (PEF)
Tidsramme: Baseline, 12 weeks and 24 weeks
|
Change in participant's Peak expiratory flow
|
Baseline, 12 weeks and 24 weeks
|
Samarbeidspartnere og etterforskere
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Sponsor
Publikasjoner og nyttige lenker
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Studierekorddatoer
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Studer hoveddatoer
Studiestart (Forventet)
1. august 2021
Primær fullføring (Forventet)
1. august 2022
Studiet fullført (Forventet)
1. august 2022
Datoer for studieregistrering
Først innsendt
11. juni 2021
Først innsendt som oppfylte QC-kriteriene
29. juni 2021
Først lagt ut (Faktiske)
8. juli 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. juli 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. juni 2021
Sist bekreftet
1. september 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Sykdommer i luftveiene
- Sykdommer i immunsystemet
- Lungesykdommer
- Overfølsomhet, Umiddelbar
- Bronkiale sykdommer
- Lungesykdommer, obstruktiv
- Respiratorisk overfølsomhet
- Overfølsomhet
- Astma
- Fysiologiske effekter av legemidler
- Autonome agenter
- Agenter fra det perifere nervesystemet
- Anti-inflammatoriske midler
- Dermatologiske midler
- Bronkodilatatorer
- Anti-astmatiske midler
- Luftveismidler
- Anti-allergiske midler
- Flutikason
- Xhance
Andre studie-ID-numre
- KY20202053-F-1
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