Asthma in ChildrenPhase 4NCT04953741
A Comparative Study on the Efficacy of Different Stepping-down Therapy for Childhood Asthma
A Phase 4 study testing Fluticasone propionate inhaled aerosol in people with Asthma in Children, run by Xijing Hospital at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 4 to 14 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Fluticasone propionate inhaled aerosol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 1 Aug 2022
- 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 4 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Pediatrics, Xijing Hospital
Xi’an, Shanxi, 710032
Xin Sun, doctor, +8613572536262, sunxin6@fmmu.edu.cn
About this study
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).
Read the detailed description
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.
- Conditions
- Asthma in Children
- Being tested
- Fluticasone propionate inhaled aerosol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone propionate inhaled aerosolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Stop Fluticasone propionate Inhaled Aerosol Firstly | Active comparator | 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 Receives: Drug: Fluticasone propionate inhaled aerosol |
| Stop Montelukast Secondly | Active comparator | 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 Receives: Drug: Fluticasone propionate inhaled aerosol |
| Stop Montelukast Firstly | Active comparator | 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 Receives: Drug: Fluticasone propionate inhaled aerosol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Test (ACT) score
Change in participant's Asthma Control Test (ACT) score
Measured: 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
Participants Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
Measured: Baseline (Week 0) to Week 12
Number of Participants Who Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
Participants Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
Measured: Baseline (Week 0) to Week 24
Secondary outcomes (5)
Fractional exhaled Nitric Oxide, FeNO
Change in participant's Fractional exhaled Nitric Oxide
Measured: Baseline, 12 weeks and 24 weeks
Forced expiratory volume in one second in predicted（FEV1%pred）
Change in participant's Forced expiratory volume in one second in predicted
Measured: Baseline, 12 weeks and 24 weeks
Forced vital capacity in predicted(FVC%pred)
Change in participant's Forced vital capacity in predicted
Measured: Baseline, 12 weeks and 24 weeks
Maximal mid expiratory flow in predicted(MMEF%pred)
Change in participant's Maximal mid expiratory flow in predicted
Measured: Baseline, 12 weeks and 24 weeks
Peak expiratory flow (PEF)
Change in participant's Peak expiratory flow
Measured: Baseline, 12 weeks and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion1 Aug 2022 (estimated)
- Study completion1 Aug 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma in ChildrenStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953741
- Sponsor's protocol ID
- KY20202053-F-1
- Status last verified
- Sep 2020
- First submitted
- 11 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Bernstein JA, Mansfield L. Step-up and step-down treatments for optimal asthma control in children and adolescents. J Asthma. 2019 Jul;56(7):758-770. doi: 10.1080/02770903.2018.1490752. Epub 2018 Sep 12.
PubMed 29972079
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study on the Efficacy of Different Stepping-down Therapy for Childhood Asthma
- ClinicalTrials.gov ID
- NCT04953741
- Acronym / sponsor ID
- KY20202053-F-1
- Conditions
- Asthma in Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 1 Aug 2022 (estimated)
- Study completion
- 1 Aug 2022 (estimated)
- First posted
- 8 Jul 2021 (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.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stop Fluticasone propionate Inhaled Aerosol Firstly | Active comparator | Drug: Fluticasone propionate inhaled aerosolReduced 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 |
| Stop Montelukast Secondly | Active comparator | Drug: Fluticasone propionate inhaled aerosolReduced 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 |
| Stop Montelukast Firstly | Active comparator | Drug: Fluticasone propionate inhaled aerosolstopped 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 |
Who may qualify
- Ages
- 4 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
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 |
|---|---|---|
| Fluticasone propionate inhaled aerosolThe 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. | Drug | Stop Fluticasone propionate Inhaled Aerosol Firstly, Stop Montelukast Firstly, Stop Montelukast Secondly |
Primary outcome
Asthma Control Test (ACT) score
Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks
Change in participant's Asthma Control Test (ACT) score
Number of Participants Who Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
Time frame: Baseline (Week 0) to Week 12
Participants Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
Number of Participants Who Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
Time frame: Baseline (Week 0) to Week 24
Participants Experienced asthma exacerbation or used oral/intravenous corticosteroids as needed
5 secondary outcomes
Fractional exhaled Nitric Oxide, FeNO
Time frame: Baseline, 12 weeks and 24 weeks
Forced expiratory volume in one second in predicted（FEV1%pred）
Time frame: Baseline, 12 weeks and 24 weeks
Forced vital capacity in predicted(FVC%pred)
Time frame: Baseline, 12 weeks and 24 weeks
Maximal mid expiratory flow in predicted(MMEF%pred)
Time frame: Baseline, 12 weeks and 24 weeks
Peak expiratory flow (PEF)
Time frame: Baseline, 12 weeks and 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- Results publication: PubMed 29972079Bernstein JA, Mansfield L. Step-up and step-down treatments for optimal asthma control in children and adolescents. J Asthma. 2019 Jul;56(7):758-770. doi: 10.1080/02770903.2018.1490752. Epub 2018 Sep 12.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluticasone propionate inhaled aerosol in people with Asthma in Children, run by Xijing Hospital at 1 site in China.
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 3 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: status not confirmed, as of the sponsor's last update on 8 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Sun, doctor (+8613572536262, sunxin6@fmmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Test (ACT) score (time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, 16 weeks, 20 weeks and 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04953741, which also lists 1 linked publication.
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 8 Jul 2021.