A Comparative Study on the Efficacy of Different Stepping-down Therapy for Childhood Asthma
29 juni 2021 uppdaterad 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).
Studieöversikt
Status
Okänd
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Förväntat)
90
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Shanxi
-
Xi'an, Shanxi, Kina, 710032
- Department of Pediatrics, Xijing Hospital
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
4 år till 14 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Asthma Control Test (ACT) score
Tidsram: 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
Tidsram: 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
Tidsram: Baseline (Week 0) to Week 24
|
Participants Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
|
Baseline (Week 0) to Week 24
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Fractional exhaled Nitric Oxide, FeNO
Tidsram: 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）
Tidsram: 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)
Tidsram: 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)
Tidsram: 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)
Tidsram: Baseline, 12 weeks and 24 weeks
|
Change in participant's Peak expiratory flow
|
Baseline, 12 weeks and 24 weeks
|
Samarbetspartners och utredare
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Sponsor
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Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Förväntat)
1 augusti 2021
Primärt slutförande (Förväntat)
1 augusti 2022
Avslutad studie (Förväntat)
1 augusti 2022
Studieregistreringsdatum
Först inskickad
11 juni 2021
Först inskickad som uppfyllde QC-kriterierna
29 juni 2021
Första postat (Faktisk)
8 juli 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
8 juli 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 juni 2021
Senast verifierad
1 september 2020
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Luftvägssjukdomar
- Immunsystemets sjukdomar
- Lungsjukdomar
- Överkänslighet, Omedelbar
- Bronkialsjukdomar
- Lungsjukdomar, obstruktiv
- Respiratorisk överkänslighet
- Överkänslighet
- Astma
- Läkemedels fysiologiska effekter
- Autonoma agenter
- Agenter från det perifera nervsystemet
- Antiinflammatoriska medel
- Dermatologiska medel
- Bronkdilaterande medel
- Anti-astmatiska medel
- Andningsorgan
- Anti-allergiska medel
- Flutikason
- Xhance
Andra studie-ID-nummer
- KY20202053-F-1
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Ja
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Ja
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