AsthmaPhase 4EXPANDNCT02577497
Effect of Extra- Fine Versus Coarse-Particle Inhaled Corticosteroids (ICS) on Ventilation Heterogeneity in Children With Poorly Controlled Asthma
A Phase 4 study testing beclomethasone and fluticasone in people with Asthma, run by University of Virginia at 1 site in United States.
Trial summary
The primary objective of the study is to show that ventilation heterogeneity identified by hyperpolarized helium-3 lung MRI is prevalent children with poorly controlled asthma despite guidelines-based treatment with ICS. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Asthma
- What is being tested?
- beclomethasone and fluticasone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 6 Jul 2018
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Boys and girls between the ages of 6 and 17 years
- Diagnosis of asthma based on NAEPP3 criteria
- Poor asthma control based on one or more of the following criteria:
- an ACT ≤ 19 and/or ACQ ≥ 1.5 units at the screening and/or randomization visits despite continuous or intermittent treatment with ICS and/or an anti-leukotriene within six months before enrollment.
- Any airflow obstruction based on Hankinson et al reference standards: FEV1 % < 80% predicted, an FEV1/FVC ratio < 90% predicted, and/or an FEF 25-75 < 70% predicted at the screening and/or randomization visits.
- Frequent severe exacerbations as reflected by ≥ 2 bursts of systemic corticosteroids (≥ 3 days each) in the previous 12 months.
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- Serious exacerbations reflected by at least one hospitalization, ICU stay, or mechanical ventilation in the previous 12 months
- "Not well controlled" by NAEPP or GINA asthma treatment guidelines
- For post-pubertal females, negative urine pregnancy screen and willing if sexually active (as counseled by a female study coordinator in private) to using a consistent and appropriate method of birth control for the duration of the study.
Who cannot join
- Premature birth < 35 weeks estimated gestational age
- Maintenance oral prednisone (defined as daily or alternate day for the past three months before screening) or omalizumab treatment for asthma control
- Any significant medical condition that might inform maldistribution of ventilation apart from asthma including bronchiectasis, cardiac disease, congenital anomalies of the respiratory system, neurodevelopmental delay with cognitive impairment, ciliary dyskinesia syndromes, immune deficiency, recent lower respiratory infection (within six weeks of screen visit). Co-morbidities associated with asthma including sleep apnea syndrome, obesity, GERD, and right middle lobe syndrome are not criteria for exclusion.
- Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in the eye, pacemaker, or other contraindication to MR scanning. Subjects with any implanted device that cannot be verified as MRI compliant will be excluded.
- Chest circumference greater than that of the helium coil. The circumference of the coil is approximately 42 inches.
- Inability to understand simple instructions or to hold still for 10 seconds.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia - Fontaine Research Park
Charlottesville, Virginia, 22908
About this study
The primary objective of the study is to show that ventilation heterogeneity identified by hyperpolarized helium-3 lung MRI is prevalent children with poorly controlled asthma despite guidelines-based treatment with ICS. The secondary objective is to demonstrate whether or not eight weeks of treatment with extra-fine particle ICS (HFA-BDP) improves ventilation heterogeneity compared to treatment with a coarse particle ICS (fluticasone HFA or dry powder).
- Conditions
- Asthma
- Being tested
- beclomethasone, fluticasone
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
beclomethasoneDrug
fluticasoneDrug
| Study group | Role | What they receive |
|---|---|---|
| Beclomethasone | Experimental | Subjects are being randomized to 8 weeks of beclomethasone or fluticasone treatment followed by a 4 week study drug washout with resumption of standard asthma medication regimen for 4 weeks, followed by 8 weeks of beclomethasone or fluticasone (whichever drug was not taken the first 8 weeks) Receives: Drug: beclomethasone |
| fluticasone | Experimental | Subjects are being randomized to 8 weeks of beclomethasone or fluticasone treatment followed by a 4 week study drug washout with resumption of standard asthma medication regimen for 4 weeks, followed by 8 weeks of beclomethasone or fluticasone (whichever drug was not taken the first 8 weeks) Receives: Drug: fluticasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ventilation Heterogeneity Index (VHI)
VHI = lung defect volume divided by total lung volume. It is a ratio scale.
Measured: Baseline
Secondary outcomes (1)
Change in Ventilation Heterogenity Index (VHI)
VHI = lung defect volume divided by total lung volume. This is a ratio scale that will be measured at four timepoints: enrollment (week 0), end of treatment 1(week 12), start of treatment 2 (week 16), and end of treatment 2 (week 24). The VHI will be compared at the beginning and end of phase 1 and at the beginning and end of phase two using ANOVA based on a mixed-effects model, with fixed effects of sequence, period, and treatment of a random effect of subject within sequence, and baseline covariate.
Measured: Baseline (week 0), week 12, week 16, and week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2015 (estimated)
- Study startJun 2016
- Primary completion6 Jul 2018
- Study completion6 Jul 2018
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 AsthmaStudies of the same condition, open and under way.
- More trials run by University of VirginiaThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Willliam Gerald Teague, University of Virginia
- Investigators
- W. Gerald Teague, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02577497
- Sponsor's protocol ID
- 18422
- Acronym
- EXPAND
- Status last verified
- Oct 2018
- First submitted
- 8 Oct 2015
- Last updated
- 25 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gerald Teague W, Mata J, Qing K, Tustison NJ, Mugler JP, Meyer CH, de Lange EE, Shim YM, Wavell K, Altes TA. Measures of ventilation heterogeneity mapped with hyperpolarized helium-3 MRI demonstrate a T2-high phenotype in asthma. Pediatr Pulmonol. 2021 Jun;56(6):1440-1448. doi: 10.1002/ppul.25303. Epub 2021 Feb 23.
PubMed 33621442
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Extra- Fine Versus Coarse-Particle Inhaled Corticosteroids (ICS) on Ventilation Heterogeneity in Children With Poorly Controlled Asthma
- ClinicalTrials.gov ID
- NCT02577497
- Acronym / sponsor ID
- EXPAND / 18422
- Conditions
- Asthma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- Jun 2016 (actual)
- Primary completion
- 6 Jul 2018 (actual)
- Study completion
- 6 Jul 2018 (actual)
- First posted
- 16 Oct 2015 (estimated)
- 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 primary objective of the study is to show that ventilation heterogeneity identified by hyperpolarized helium-3 lung MRI is prevalent children with poorly controlled asthma despite guidelines-based treatment with ICS. The secondary objective is to demonstrate whether or not eight weeks of treatment with extra-fine particle ICS (HFA-BDP) improves ventilation heterogeneity compared to treatment with a coarse particle ICS (fluticasone HFA or dry powder).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beclomethasone | Experimental | Drug: beclomethasoneSubjects are being randomized to 8 weeks of beclomethasone or fluticasone treatment followed by a 4 week study drug washout with resumption of standard asthma medication regimen for 4 weeks, followed by 8 weeks of beclomethasone or fluticasone (whichever drug was not taken the first 8 weeks) |
| fluticasone | Experimental | Drug: fluticasoneSubjects are being randomized to 8 weeks of beclomethasone or fluticasone treatment followed by a 4 week study drug washout with resumption of standard asthma medication regimen for 4 weeks, followed by 8 weeks of beclomethasone or fluticasone (whichever drug was not taken the first 8 weeks) |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- Boys and girls between the ages of 6 and 17 years
- Diagnosis of asthma based on NAEPP3 criteria
- Poor asthma control based on one or more of the following criteria:
- an ACT ≤ 19 and/or ACQ ≥ 1.5 units at the screening and/or randomization visits despite continuous or intermittent treatment with ICS and/or an anti-leukotriene within six months before enrollment.
- Any airflow obstruction based on Hankinson et al reference standards: FEV1 % < 80% predicted, an FEV1/FVC ratio < 90% predicted, and/or an FEF 25-75 < 70% predicted at the screening and/or randomization visits.
Key exclusion criteria (6 listed)
- Premature birth < 35 weeks estimated gestational age
- Maintenance oral prednisone (defined as daily or alternate day for the past three months before screening) or omalizumab treatment for asthma control
- Any significant medical condition that might inform maldistribution of ventilation apart from asthma including bronchiectasis, cardiac disease, congenital anomalies of the respiratory system, neurodevelopmental delay with cognitive impairment, ciliary dyskinesia syndromes, immune deficiency, recent lower respiratory infection (within six weeks of screen visit). Co-morbidities associated with asthma including sleep apnea syndrome, obesity, GERD, and right middle lobe syndrome are not criteria for exclusion.
- Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in the eye, pacemaker, or other contraindication to MR scanning. Subjects with any implanted device that cannot be verified as MRI compliant will be excluded.
- Chest circumference greater than that of the helium coil. The circumference of the coil is approximately 42 inches.
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 |
|---|---|---|
| beclomethasone | Drug | Beclomethasone |
| fluticasone | Drug | fluticasone |
Primary outcome
Ventilation Heterogeneity Index (VHI)
Time frame: Baseline
VHI = lung defect volume divided by total lung volume. It is a ratio scale.
1 secondary outcome
Change in Ventilation Heterogenity Index (VHI)
Time frame: Baseline (week 0), week 12, week 16, and week 24
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 25 Oct 2018.
- Derived from this study: PubMed 33621442Gerald Teague W, Mata J, Qing K, Tustison NJ, Mugler JP, Meyer CH, de Lange EE, Shim YM, Wavell K, Altes TA. Measures of ventilation heterogeneity mapped with hyperpolarized helium-3 MRI demonstrate a T2-high phenotype in asthma. Pediatr Pulmonol. 2021 Jun;56(6):1440-1448. doi: 10.1002/ppul.25303. Epub 2021 Feb 23.
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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.
W. Gerald Teague, MD principal investigator
University of Virginia
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 beclomethasone and fluticasone in people with Asthma, run by University of Virginia at 1 site in United States.
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 9 inclusion and 6 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 25 Oct 2018. 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 United States. 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?
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?
Ventilation Heterogeneity Index (VHI) (time frame: Baseline). 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 NCT02577497, 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 25 Oct 2018.