Asthma in ChildrenNCT04509921
Adjustment of Asthma Treatment in Children Based on an Indirect Hyperresponsiveness Test
A study testing asthma treatment adjustment taking account on degree of bronchial hyperresponsiveness in people with Asthma in Children, run by National Institute for Tuberculosis and Lung Diseases, Poland at 1 site in Poland.
Trial summary
The aim of the study is to assess the usefulness of the indirect bronchial hyperresponsiveness test (with hypertonic NaCl) in determining the optimal dose of inhaled steroids to maintain asthma control. The study was designed as a prospective, real-life, randomized, interventional study. Read more about this study
- Who is it for?
- Ages 7 to 15 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- asthma treatment adjustment taking account on degree of bronchial hyperresponsiveness
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 1 sitePoland
- Study dates
- 2 Jul 2018to 30 Aug 2019
- Phase
- Interventional
- 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 7 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- mild asthma with a stable course of at least 3 months
- good adherence to treatment with low dose ICS
Who cannot join
- infection or exacerbation of asthma requiring the use of systemic steroids (or changes in the dose of inhaled steroids) in the last 3 months before the study
- other chronic lung diseases or general diseases affecting the respiratory system
- tobacco smoking
- FEV1 below 80% of the predicted value
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adjustment of Asthma Treatment in Children Based on an Indirect Hyperresponsiveness Test - a Randomized Trial
The aim of the study is to assess the usefulness of the indirect bronchial hyperresponsiveness test (with hypertonic NaCl) in determining the optimal dose of inhaled steroids to maintain asthma control.
The study was designed as a prospective, real-life, randomized, interventional study. This single-site study is performed at the Allergology Clinic in Lesko.
Read more
The study included participants aged 7-15 years who met the eligibility criteria. Eligible participants were selected from a pool of 231 patients with mild asthma, under the care of the Allergology Clinic of the Regional Public Hospital in Lesko (Poland). All participants were diagnosed with chronic mild asthma for at least two years.
Subjects initially enrolled in the study had good asthma control maintained for at least 3 months on low / medium-dose ICS monotherapy, with no exacerbations requiring systemic corticosteroids in the previous 3 months, no respiratory tract infection in last month, and an FEV1 above 80% expected.
Finally, 108 children were enrolled in the study. They were aged 7-15 years, with active mild asthma, confirmed by the presence of bronchial hyperreactivity and symptoms of asthma, emerging after discontinuation of anti-inflammatory treatment.
Participation in the study lasted one year.
The study includes:
4-week run-in period (withdrawal phase) after discontinuation of anti-inflammatory treatment (ICS) with clinical symptoms and medication use recording, completed by the patient and parents.
At the end of this period, spirometry was performed, bronchial hyperreactivity was assessed with the hyperosmolar salt provocation, and the parameters of inflammation were measured: orally exhaled nitric oxide concentration (NO) and peripheral blood eosinophilia. The anti-inflammatory treatment was then resumed (with ICS in the previous doses).
Only patients with active asthma and increased bronchial responsiveness (DRS>0.55) were qualified for the main study. Stratified randomization was performed for age, clinical symptoms, and the degree of bronchial hyperresponsiveness. On this basis, the division into 2 research groups was made:
- a symptom-only monitored treatment group
- a group in which therapy changes were based on the symptoms and degree of bronchial hyperresponsiveness (BHR group).
Patients/parents were provided by an established algorithm for managing asthma symptoms/exacerbations. In the case of loss of asthma control, a beta-agonist was administered (temporarily) and the dose of ICS quadrupled. Patients had the possibility of additional visits - if necessary. Especially, severe exacerbations were verified by the attending physician, and on this basis, oral steroids would be considered.
Throughout the study, the participants kept daily observation charts (clinical symptoms and drug use) and peak expiratory flow rate (PEFR) measurements.
The telephone report was made monthly with the number of days with asthma symptoms and medications used, and this was recorded in the documentation of the study.
The clinical evaluation was performed every 3 months with symptom evaluation, spirometry, exhaled NO, peripheral blood eosinophilia, and BHR measurements (half of the patients).
The treatment adjustments were guided by the patient's and parent's reporting of symptoms, and additionally by the results of periodic clinical assessment (including the assessment of bronchial hyperresponsiveness in the BHR group). This means that the level of treatment intensity (ICS dose) was based on symptom monitoring only in the observation group, and additionally took into account the level of bronchial responsiveness in the BHR monitoring group.
The study was completed after one year of follow-up (4 visits every 3 months). The primary endpoint of the study: the number of asthma exacerbations in both study arms.
Secondary endpoints:
- days with symptoms
- asthma medication days
- final dose of ICS
- spirometry (FEV1, MMEF)
- bronchial hyperreactivity (BHR group only)
- nitric oxide in the exhaled air
- peripheral blood eosinophilia.
- Conditions
- Asthma in Children
- Being tested
- asthma treatment adjustment taking account on degree of bronchial hyperresponsiveness
- Keywords
- asthma, bronchoprovocation, inhaled corticosteroids
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
asthma treatment adjustment taking account on degree of bronchial hyperresponsivenessOther
Modification of inhaled corticosteroid dose based on the symptoms and the result of bronchial provocation (BHR group)
| Study group | Role | What they receive |
|---|---|---|
| symptoms group | No intervention | The asthma treatment adjustments guided by GINA guidelines |
| BHR group | Experimental | The asthma treatment adjustments additionally taking account to the results of the bronchial hyperresponsiveness test Receives: Other: asthma treatment adjustment taking account on degree of bronchial hyperresponsiveness |
What is being measured
The primary outcome is the main question the study is designed to answer.
asthma exacerbations
number of asthma exacerbations
Measured: 12 months
Secondary outcomes (8)
the percentage of participants with asthma exacerbations
the number of patients with at least 1 exacerbation divided by the number of patients in each group
Measured: 12 months
time to the first asthma exacerbation
the median time to the first asthma exacerbation in each group
Measured: 12 months
ICS dose
the final dose of ICS
Measured: 12 months
days with symptoms
total number of days with asthma symptoms
Measured: 12 months
days with asthma medication
total number of days with bronchodilator use
Measured: 12 months
blood eosinophilia
number of blood eosinophils
Measured: 12 months
exhaled nitric oxide
orally exhaled nitric oxide concentration
Measured: 12 months
spirometry
FEV1, forced vital capacity (FVC) and FEF (MMEF) values
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2020
- Study start2 Jul 2018
- Primary completion30 Aug 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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 N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute for Tuberculosis and Lung Diseases, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- The Regional Public Hospital in Lesko, Poland, University of Rzeszow
- Responsible party
- Principal investigator, Henryk Mazurek, National Institute for Tuberculosis and Lung Diseases, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04509921
- Sponsor's protocol ID
- BA_BHR
- Status last verified
- Aug 2020
- First submitted
- 7 Aug 2020
- Last updated
- 12 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nuijsink M, Hop WC, Sterk PJ, Duiverman EJ, de Jongste JC. Long-term asthma treatment guided by airway hyperresponsiveness in children: a randomised controlled trial. Eur Respir J. 2007 Sep;30(3):457-66. doi: 10.1183/09031936.00111806. Epub 2007 May 30.
PubMed 17537770Lipworth BJ, Short PM, Williamson PA, Clearie KL, Fardon TC, Jackson CM. A randomized primary care trial of steroid titration against mannitol in persistent asthma: STAMINA trial. Chest. 2012 Mar;141(3):607-615. doi: 10.1378/chest.11-1748. Epub 2011 Oct 13.
PubMed 21998259Szefler SJ, Mitchell H, Sorkness CA, Gergen PJ, O'Connor GT, Morgan WJ, Kattan M, Pongracic JA, Teach SJ, Bloomberg GR, Eggleston PA, Gruchalla RS, Kercsmar CM, Liu AH, Wildfire JJ, Curry MD, Busse WW. Management of asthma based on exhaled nitric oxide in addition to guideline-based treatment for inner-city adolescents and young adults: a randomised controlled trial. Lancet. 2008 Sep 20;372(9643):1065-72. doi: 10.1016/S0140-6736(08)61448-8.
PubMed 18805335Voorend-van Bergen S, Vaessen-Verberne AA, Brackel HJ, Landstra AM, van den Berg NJ, Hop WC, de Jongste JC, Merkus PJ, Pijnenburg MW. Monitoring strategies in children with asthma: a randomised controlled trial. Thorax. 2015 Jun;70(6):543-50. doi: 10.1136/thoraxjnl-2014-206161. Epub 2015 Mar 30.
PubMed 25825006Virchow JC, Backer V, de Blay F, Kuna P, Ljorring C, Prieto JL, Villesen HH. Defining moderate asthma exacerbations in clinical trials based on ATS/ERS joint statement. Respir Med. 2015 May;109(5):547-56. doi: 10.1016/j.rmed.2015.01.012. Epub 2015 Feb 3.
PubMed 25676887Voorend-van Bergen S, Vaessen-Verberne AA, Landstra AM, Brackel HJ, van den Berg NJ, Caudri D, de Jongste JC, Merkus PJ, Pijnenburg MW. Monitoring childhood asthma: web-based diaries and the asthma control test. J Allergy Clin Immunol. 2014 Jun;133(6):1599-605.e2. doi: 10.1016/j.jaci.2013.10.005. Epub 2013 Nov 28.
PubMed 24290276Nuijsink M, De Jongste JC, Pijnenburg MW. Will symptom-based therapy be effective for treating asthma in children? Curr Allergy Asthma Rep. 2013 Oct;13(5):421-6. doi: 10.1007/s11882-013-0364-x.
PubMed 23775350Moeller A, Carlsen KH, Sly PD, Baraldi E, Piacentini G, Pavord I, Lex C, Saglani S; ERS Task Force Monitoring Asthma in Children. Monitoring asthma in childhood: lung function, bronchial responsiveness and inflammation. Eur Respir Rev. 2015 Jun;24(136):204-15. doi: 10.1183/16000617.00003914.
PubMed 26028633
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjustment of Asthma Treatment in Children Based on an Indirect Hyperresponsiveness Test - a Randomized Trial
- ClinicalTrials.gov ID
- NCT04509921
- Acronym / sponsor ID
- BA_BHR
- Conditions
- Asthma in Children
- Keywords
- asthma, bronchoprovocation, inhaled corticosteroids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- National Institute for Tuberculosis and Lung Diseases, PolandUniversity, hospital or other
- Collaborators
- The Regional Public Hospital in Lesko, Poland, University of Rzeszow
- Study start
- 2 Jul 2018 (actual)
- Primary completion
- 30 Aug 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 12 Aug 2020 (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.
The aim of the study is to assess the usefulness of the indirect bronchial hyperresponsiveness test (with hypertonic NaCl) in determining the optimal dose of inhaled steroids to maintain asthma control.
The study was designed as a prospective, real-life, randomized, interventional study. This single-site study is performed at the Allergology Clinic in Lesko.
The study included participants aged 7-15 years who met the eligibility criteria. Eligible participants were selected from a pool of 231 patients with mild asthma, under the care of the Allergology Clinic of the Regional Public Hospital in Lesko (Poland). All participants were diagnosed with chronic mild asthma for at least two years.
Subjects initially enrolled in the study had good asthma control maintained for at least 3 months on low / medium-dose ICS monotherapy, with no exacerbations requiring systemic corticosteroids in the previous 3 months, no respiratory tract infection in last month, and an FEV1 above 80% expected.
Finally, 108 children were enrolled in the study. They were aged 7-15 years, with active mild asthma, confirmed by the presence of bronchial hyperreactivity and symptoms of asthma, emerging after discontinuation of anti-inflammatory treatment.
Participation in the study lasted one year.
The study includes:
4-week run-in period (withdrawal phase) after discontinuation of anti-inflammatory treatment (ICS) with clinical symptoms and medication use recording, completed by the patient and parents.
At the end of this period, spirometry was performed, bronchial hyperreactivity was assessed with the hyperosmolar salt provocation, and the parameters of inflammation were measured: orally exhaled nitric oxide concentration (NO) and peripheral blood eosinophilia. The anti-inflammatory treatment was then resumed (with ICS in the previous doses).
Only patients with active asthma and increased bronchial responsiveness (DRS>0.55) were qualified for the main study. Stratified randomization was performed for age, clinical symptoms, and the degree of bronchial hyperresponsiveness. On this basis, the division into 2 research groups was made:
- a symptom-only monitored treatment group
- a group in which therapy changes were based on the symptoms and degree of bronchial hyperresponsiveness (BHR group).
Patients/parents were provided by an established algorithm for managing asthma symptoms/exacerbations. In the case of loss of asthma control, a beta-agonist was administered (temporarily) and the dose of ICS quadrupled. Patients had the possibility of additional visits - if necessary. Especially, severe exacerbations were verified by the attending physician, and on this basis, oral steroids would be considered.
Throughout the study, the participants kept daily observation charts (clinical symptoms and drug use) and peak expiratory flow rate (PEFR) measurements.
The telephone report was made monthly with the number of days with asthma symptoms and medications used, and this was recorded in the documentation of the study.
The clinical evaluation was performed every 3 months with symptom evaluation, spirometry, exhaled NO, peripheral blood eosinophilia, and BHR measurements (half of the patients).
The treatment adjustments were guided by the patient's and parent's reporting of symptoms, and additionally by the results of periodic clinical assessment (including the assessment of bronchial hyperresponsiveness in the BHR group). This means that the level of treatment intensity (ICS dose) was based on symptom monitoring only in the observation group, and additionally took into account the level of bronchial responsiveness in the BHR monitoring group.
The study was completed after one year of follow-up (4 visits every 3 months). The primary endpoint of the study: the number of asthma exacerbations in both study arms.
Secondary endpoints:
- days with symptoms
- asthma medication days
- final dose of ICS
- spirometry (FEV1, MMEF)
- bronchial hyperreactivity (BHR group only)
- nitric oxide in the exhaled air
- peripheral blood eosinophilia.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| symptoms group | No intervention | –The asthma treatment adjustments guided by GINA guidelines |
| BHR group | Experimental | Other: asthma treatment adjustment taking account on degree of bronchial hyperresponsivenessThe asthma treatment adjustments additionally taking account to the results of the bronchial hyperresponsiveness test |
Who may qualify
- Ages
- 7 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- mild asthma with a stable course of at least 3 months
- good adherence to treatment with low dose ICS
Key exclusion criteria (4 listed)
- infection or exacerbation of asthma requiring the use of systemic steroids (or changes in the dose of inhaled steroids) in the last 3 months before the study
- other chronic lung diseases or general diseases affecting the respiratory system
- tobacco smoking
- FEV1 below 80% of the predicted value
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 |
|---|---|---|
| asthma treatment adjustment taking account on degree of bronchial hyperresponsivenessModification of inhaled corticosteroid dose based on the symptoms and the result of bronchial provocation (BHR group) | Other | BHR group |
Primary outcome
asthma exacerbations
Time frame: 12 months
number of asthma exacerbations
8 secondary outcomes
the percentage of participants with asthma exacerbations
Time frame: 12 months
time to the first asthma exacerbation
Time frame: 12 months
ICS dose
Time frame: 12 months
days with symptoms
Time frame: 12 months
days with asthma medication
Time frame: 12 months
blood eosinophilia
Time frame: 12 months
exhaled nitric oxide
Time frame: 12 months
spirometry
Time frame: 12 months
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 12 Aug 2020.
- Background: PubMed 17537770Nuijsink M, Hop WC, Sterk PJ, Duiverman EJ, de Jongste JC. Long-term asthma treatment guided by airway hyperresponsiveness in children: a randomised controlled trial. Eur Respir J. 2007 Sep;30(3):457-66. doi: 10.1183/09031936.00111806. Epub 2007 May 30.
- Background: PubMed 21998259Lipworth BJ, Short PM, Williamson PA, Clearie KL, Fardon TC, Jackson CM. A randomized primary care trial of steroid titration against mannitol in persistent asthma: STAMINA trial. Chest. 2012 Mar;141(3):607-615. doi: 10.1378/chest.11-1748. Epub 2011 Oct 13.
- Background: PubMed 18805335Szefler SJ, Mitchell H, Sorkness CA, Gergen PJ, O'Connor GT, Morgan WJ, Kattan M, Pongracic JA, Teach SJ, Bloomberg GR, Eggleston PA, Gruchalla RS, Kercsmar CM, Liu AH, Wildfire JJ, Curry MD, Busse WW. Management of asthma based on exhaled nitric oxide in addition to guideline-based treatment for inner-city adolescents and young adults: a randomised controlled trial. Lancet. 2008 Sep 20;372(9643):1065-72. doi: 10.1016/S0140-6736(08)61448-8.
- Background: PubMed 25825006Voorend-van Bergen S, Vaessen-Verberne AA, Brackel HJ, Landstra AM, van den Berg NJ, Hop WC, de Jongste JC, Merkus PJ, Pijnenburg MW. Monitoring strategies in children with asthma: a randomised controlled trial. Thorax. 2015 Jun;70(6):543-50. doi: 10.1136/thoraxjnl-2014-206161. Epub 2015 Mar 30.
- Background: PubMed 25676887Virchow JC, Backer V, de Blay F, Kuna P, Ljorring C, Prieto JL, Villesen HH. Defining moderate asthma exacerbations in clinical trials based on ATS/ERS joint statement. Respir Med. 2015 May;109(5):547-56. doi: 10.1016/j.rmed.2015.01.012. Epub 2015 Feb 3.
- Background: PubMed 24290276Voorend-van Bergen S, Vaessen-Verberne AA, Landstra AM, Brackel HJ, van den Berg NJ, Caudri D, de Jongste JC, Merkus PJ, Pijnenburg MW. Monitoring childhood asthma: web-based diaries and the asthma control test. J Allergy Clin Immunol. 2014 Jun;133(6):1599-605.e2. doi: 10.1016/j.jaci.2013.10.005. Epub 2013 Nov 28.
- Background: PubMed 23775350Nuijsink M, De Jongste JC, Pijnenburg MW. Will symptom-based therapy be effective for treating asthma in children? Curr Allergy Asthma Rep. 2013 Oct;13(5):421-6. doi: 10.1007/s11882-013-0364-x.
- Background: PubMed 26028633Moeller A, Carlsen KH, Sly PD, Baraldi E, Piacentini G, Pavord I, Lex C, Saglani S; ERS Task Force Monitoring Asthma in Children. Monitoring asthma in childhood: lung function, bronchial responsiveness and inflammation. Eur Respir Rev. 2015 Jun;24(136):204-15. doi: 10.1183/16000617.00003914.
- GINA guidelinesLink provided by the sponsor.
Related trials for Asthma in Children
Not yet recruiting
Asthma Ctrl SMART Trial
Asthma in Children, Asthma Chronic
Not yet recruiting
Artificially Intelligent Robot Control
Asthma in Children, Artificial Intelligence
Not yet recruiting
Bilevel Positive Airway Pressure (BPAP) for Severe Asthma
Pediatric Asthma, Acute Asthma
Recruiting
Effects of Tele-rehabilitation-Guided Qigong on Children and Adolescents With Asthma
Asthma Childhood
Enrolling by invitationObservational study
Investigating Novel Strategies in Pediatric Immune Responses and Microbiome Environment: Comprehensive Lung Disease Investigation in Children.
Lung Diseases
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing asthma treatment adjustment taking account on degree of bronchial hyperresponsiveness in people with Asthma in Children, run by National Institute for Tuberculosis and Lung Diseases, Poland at 1 site in Poland.
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 2 inclusion and 4 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 12 Aug 2020. 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 Poland. 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.
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?
asthma exacerbations (time frame: 12 months). 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 NCT04509921, which also lists 8 linked publications.
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 12 Aug 2020.